Spreadsheet: 0145cd73-2f44-4cb0-ab9e-77c21fdf6296
Sheet: Sheet1

DIA EDM Reference Model for Regulatory Submissions | Unnamed: 1 | Unnamed: 2 | Unnamed: 3 | Unnamed: 4 | Unnamed: 5 | Unnamed: 6 | Version 1.3 | Unnamed: 8 | 2013-04-18 00:00:00 | Unnamed: 10 | Unnamed: 11 | Unnamed: 12 | Unnamed: 13 | Unnamed: 14 | Unnamed: 15 | Unnamed: 16 | Unnamed: 17 | Unnamed: 18 | Unnamed: 19 | Unnamed: 20 | Unnamed: 21 | Unnamed: 22 | Unnamed: 23 | Unnamed: 24 | Unnamed: 25 | Unnamed: 26 | Unnamed: 27 | Unnamed: 28 | Unnamed: 29 | Unnamed: 30 | Unnamed: 31 | Unnamed: 32 | Unnamed: 33 | Unnamed: 34 | Unnamed: 35 | Unnamed: 36 | Unnamed: 37 | Unnamed: 38 | Unnamed: 39 | Unnamed: 40 | Unnamed: 41 | Unnamed: 42 | Unnamed: 43 | Unnamed: 44 | Unnamed: 45 | Unnamed: 46 | Unnamed: 47 | Unnamed: 48 | Unnamed: 49 | Unnamed: 50 | Unnamed: 51 | Unnamed: 52 | Unnamed: 53 | Unnamed: 54 | Unnamed: 55 | Unnamed: 56 | Unnamed: 57 | Unnamed: 58 | Unnamed: 59 | Unnamed: 60 | Unnamed: 61 | Unnamed: 62 | Unnamed: 63 | Unnamed: 64 | Unnamed: 65 | Unnamed: 66 | Unnamed: 67 | Unnamed: 68 | Unnamed: 69 | Unnamed: 70 | Unnamed: 71 | Unnamed: 72 | Unnamed: 73 | Unnamed: 74 | Unnamed: 75
Artifacts should not be combined or split:
Unless submission output is paper volumes
If granularity is not supported in ICH M4(R3) granularity annex http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_Organisation/M4_R3__organisation.pdf
If granularity is not supported by target health authority guidances, regulations, and specifications
Each artifact as listed includes all approvals, amendments and change summaries (change control), translations and certifications.  Retention of draft versions is at the discretion of the sponsor.
Drafts to be excluded unless specifically submitted for approval
x
M = suggested "Mandatory" metadata
O = suggested "Optional" metadata
 | Pharmaceutical Content Architecture |  | Date:
 | Context of Use: | Regulatory Submission | 2009-10-30 00:00:00
Document Taxonomy |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Entity | Attribute Label
 | Process Zone | Domain | Group | Sub-Group | Region |  | Artifact Name |  |  | Domain Specific - Columns apply to '[NAME]' column |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Product Name | NOTE: At least one required |  |  |  |  | Content Management |  |  |  |  |  |  |  | Document Management
 |  |  |  |  |  |  | Work in progress |  |  | REGULATORY/ADMIN | Applicant Address | [NAME] | Application Number | Application Status | Application Type | ATC Code | Authorization Number | Concentration | Dispatch Date | Dosage Form | Dosage Strength | Drug Indication | Fill Volume | Generic Name | Health Authority | [NAME] | [NAME] | Manufacturing Site | Market Authorization Holder | Packaging Component | Procedure Type | Region | Related Sequence Number | Renewal Date | Route of Administration | Sequence Number | Submission Date | Submission Description | Submission Type | Submission Country | Trade Name |  | Region | Submission Country | Application Type | Submission Type | Procedure Type | Transaction | CTD/Section | Project | Submit Date |  |  | Chemical Name | Compound ID | Generic Name | Trade Name |  |  | Author | Business Owner | Component Name | Contributor | Document Title | Issued Date |  |  | Creation Date | Creator | Language | Litigation Hold | Modify Date | Status | Version Label | Version Number
 |  |  |  |  |  |  | Work in progress |  |  | TMF
 |  |  |  |  |  |  | Work in progress |  |  | PHARMVIG
 |  |  |  |  |  |  |  |  |  | PRESCRIBING INFORMATION | Review / Approval Process Type | [NAME] | Regulatory Status Date | Product / package identifiers | Product Family | Product Class | Indication | Labeler(s) | Project | Based On | Source Labeling | Source Link | Key Changes | [NAME] | Reference Link | Artifact contents, human readable description | Internal Status | Interal Status Date | Publication Status | Publication Status Date | Flagged Statements | Layout identifiers ([NAME] codes) | Submission Document | Artifact id | Submission Date | Submission Description
 |  |  |  |  |  |  |  |  |  | QUALITY | DS Name | Manuf | Formulation | Mfg Process | Impurity | Batch Number | Container Closure | Controlled Document# | DP Name | Dosage Form | Dosage Strength
 | Process Zone | Domain | Group | Sub-Group | Region |  | Artifact Name |  |  | NON-CLIN | Study# | Study Type | Study Director | Dosage Strength | Dosage Form | Test Facility Location | Route-of-Admin | Duration | GLP | Species
Document Taxonomy |  |  |  |  |  |  |  |  |  | CLINICAL | Indication | Clinical Study # | Clinical Study Title | Route-of-Admin | Study Phase | Clinical Trial Indentifier | Type of Control | Site Identifier | [NAME] | eCTD STF Tag Elem.
 | Process Zone | Domain | Group | Sub-Group | Region |  | Artifact Name |  |  | Domain Specific - Columns apply to '[NAME]' column |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | NOTE: Inherited from submission management elements |  |  |  |  |  |  |  | Product Name | NOTE: At least one required |  |  |  |  | Content Management |  |  |  |  |  |  |  | Document Management
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Cover Letter | General |  | Cover Letter |  |  | REGULATORY/ADMIN | Applicant Address | [NAME] | Application Number | Application Status | Application Type | ATC Code | Authorization Number | Concentration | Dispatch Date | Dosage Form | Dosage Strength | Drug Indication | Fill Volume | Generic Name | Health Authority | [NAME] | [NAME] | Manufacturing Site | Market Authorization Holder | Packaging Component | Procedure Type | Region | Related Sequence Number | Renewal Date | Route of Administration | Sequence Number | Submission Date | Submission Description | Submission Type | Submission Country | Trade Name |  | Region | Submission Country | Application Type | Submission Type | Procedure Type | Transaction | CTD/Section | Project |  |  |  | Chemical Name | Compound ID | Generic Name | Trade Name |  |  | Author | Business Owner | Component Name | Contributor | Document Title | Issued Date |  |  | Creation Date | Creator | Language | Litigation Hold | Modify Date | Status | Version Label | Version Number
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Table of Contents | General |  | Table of Contents |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [NAME] | emea | MAA | initial-maa | centralised | 0000 | 1.0 | [NAME] |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | General |  | Application Form |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [NAME] | emea | MAA | initial-maa | centralised | 0000 | 1.1 | [NAME] |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | USA |  | FDA Form 1571 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | USA |  | FDA Form 356h |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.1.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | USA |  | FDA Form 3397 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | USA |  | FDA Form 2252 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.1.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | USA |  | FDA Form 2253 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.1.4 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | USA |  | FDA Form 2567 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.1.5 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | General |  | Renewal Form |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.1.6 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | General |  | Signature Page |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | General |  | Variation Form |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Regulatory Correspondence | USA |  | Pediatric Document Filing |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Regulatory Correspondence | EU |  | Scientific Advice Request |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Proof of payment |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Informed consent letter of marketing authorisation holder of authorised medicinal product |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [NAME] | emea | MAA | initial-maa | centralised | 0000 | 1.2 | [NAME] |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Proof of establishment of the applicant in the EEA |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Letter of authorisation for communication on behalf of the applicant/MAH |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Curriculum Vitae of the Qualified Person for Pharmacovigilance |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Manufacturing Authorisation |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Justification for more than one manufacturer responsible for batch release in the EEA |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Flow-chart indicating all sites involved in the manufacturing process |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Statement (or GMP Certificate issued by an EEA inspectorate, when available) from the CA which carried out the inspection of the manufacturing site(s) |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Letter(s) of access to Active Substance Master File(s) |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Written confirmation from the manufacturer of the active substance to inform the applicant in case of modification of the manufacturing process or specifications |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Ph. Eur. Certificate(s) of suitability for TSE |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Written consent(s) of the CAs regarding GMO release in the environment. |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Scientific Advice given by CHMP |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Marketing Authorization(s) |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Correspondence with EC regarding multiple applications. |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | List of Mock-ups or Samples/specimens sent with the application |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Orphan Designation Decision |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | List of proposed (invented) names and marketing authorisation holders in the concerned member states |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | EMEA certificate for a Vaccine Antigen Master File (VAMF) |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | EMEA certificate for a Plasma Master File (PMF) |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Form | EU |  | Declaration from the QP that each active substance manufacturer(s) operate in compliance with the detailed guidelines on GMP |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Sponsor Address | General |  | Change of Address |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Sponsor Agent | General |  | Change of Agent |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.3.1.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Applicant Information | General |  | Sponsor Change |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.3.1.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Contact-Sponsor-Applicant Information | General |  | Transfer of Obligation |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.3.1.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Contact-Sponsor-Applicant Information | General |  | Change of Ownership of an Application |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.3.1.4 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Administrative Information | USA |  | Field Copy Certification |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.3.1.5 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Administrative Information | USA |  | Debarment Certification |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.3.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Administrative Information | USA |  | Financial Disclosure Cover Note |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.3.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Patent and Exclusivity | USA |  | Patent Information |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.3.4 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Patent and Exclusivity | USA |  | Patent Certifications |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.3.5.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Patent and Exclusivity | USA |  | Exclusivity Request |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.3.5.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Information about the Experts | EU |  | Information about the Experts-Quality |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.3.5.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Information about the Experts | EU |  | Information about the Experts-Non-Clinical |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [NAME] | emea | MAA | initial-maa | centralised | 0000 | 1.4.1 | [NAME] |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Information about the Experts | EU |  | Information about the Experts-Clinical |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [NAME] | emea | MAA | initial-maa | centralised | 0000 | 1.4.2 | [NAME] |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | References | General |  | Letter of Authorization |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [NAME] | emea | MAA | initial-maa | centralised | 0000 | 1.4.3 | [NAME] |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | References | General |  | Statement of Right to Reference |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.4.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | References | General |  | List of Authorized to Persons to Incorporate by Reference |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.4.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | References | General |  | Cross Reference to Other Applications |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.4.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Specific Requirements for Different Types of Applications | EU |  | Information for Bibliographical Applications |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.4.4 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Specific Requirements for Different Types of Applications | EU |  | Information for Generic, 'Hybrid' or Bio-similar Applications |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.5.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Specific Requirements for Different Types of Applications | EU |  | (Extended) Data or Market Exclusivity |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.5.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Specific Requirements for Different Types of Applications | EU |  | Exceptional Circumstances |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.5.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Specific Requirements for Different Types of Applications | EU |  | Conditional Marketing Authorisation |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.5.4 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Status | General |  | Withdrawal request |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.5.5 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Status | General |  | Inactivation request |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.5.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Status | General |  | Reactivation request |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.5.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Status | General |  | Reinstatement request |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.5.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Status | USA |  | Withdrawal of an unapproved NDA |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.5.4 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Status | General |  | Withdrawal of a listed drug |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.5.5 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Status | General |  | Request for withdrawal of application approval |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.5.6 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Environmental Risk Assessment | EU |  | Environmental Risk Assessment - Non-GMO |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.5.7 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Environmental Risk Assessment | EU |  | Environmental Risk Assessment - GMO |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [NAME] | emea | MAA | initial-maa | centralised | 0000 | 1.6.1 | [NAME] |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Regulatory Meetings | General |  | Meeting Request |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.6.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Regulatory Meetings | General |  | [NAME] |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.6.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Correspondence Regarding Meetings | General |  | Regulatory Meeting Minutes |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.6.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Regulatory Meetings | General |  | Meeting Background Materials |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.6.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Regulatory Meetings | General |  | Regulatory Meeting Presentation |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.6.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Regulatory Meetings | General |  | Correspondence Regarding Meetings |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.6.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Regulatory Correspondence | General |  | Regulatory Correspondence |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.6.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Regulatory Correspondence | General |  | Post-approval Commitment |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.6.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Information relating to Orphan Market Exclusivity | EU |  | [NAME] Market Exclusivity-Similarity |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.6.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Information relating to Orphan Market Exclusivity | EU |  | [NAME] Market Exclusivity-Market Exclusivity |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.7.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Fast Track | USA |  | Fast Track Designation Request |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.7.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Fast Track Designation Withdrawal Request | USA |  | Fast Track Designation Request Withdrawal |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.7.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Fast Track | USA |  | Rolling Review Request |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.7.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Special Protocol Assessment Request | USA |  | Special Protocol Assessment Request-Clinical Study |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.7.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Special Protocol Assessment Request | USA |  | Special Protocol Assessment Request-Carcinogenicity Study |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.8.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Special Protocol Assessment Request | USA |  | Special Protocol Assessment Request-Stability Study |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.8.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Pediatric Administrative Information | USA |  | Request for Waiver of Pediatric Studies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.8.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Pediatric Administrative Information | USA |  | Request for Deferral of Pediatric Studies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.9.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Pediatric Administrative Information | USA |  | Request for Pediatric Exclusivity Determination |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.9.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Pediatric Administrative Information | USA |  | Proposed Pediatric Study Request and Amendments |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.9.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Pediatric Administrative Information | USA |  | Proposal for Written Agreement |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.9.4 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Pediatric Administrative Information | USA |  | Other Correspondence Regarding Pediatric Exclusivity or Study Plans |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.9.5 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Dispute Resolution | USA |  | Request for Dispute Resolution |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.9.6 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Dispute Resolution | USA |  | Correspondence Related to Dispute Resolution |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.10.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Information amendment (info not covered under modules 2-5) | EU |  | Multiple Module Information Amendment |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.10.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Information amendment (info not covered under modules 2-5) | EU |  | Quality Information Amendment |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.11 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Information amendment (info not covered under modules 2-5) | EU |  | Safety Information Amendment |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.11.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Information Amendment | EU |  | Efficacy Information Amendment |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.11.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Other Correspondence | General |  | Generic Drug Enforcement Act Statement |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.11.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Other Correspondence | General |  | Basis for Submission Statement |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.12.10 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Other Correspondence | General |  | Comparison of Generic Drug and Reference Listed Drug |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.12.11 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Other Correspondence | General |  | Request for Waiver for In Vivo Studies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 | 1.12.12 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Other Correspondence | General |  | Request for Waiver for In Vivo Bioavalability Studies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.12.13 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Other Correspondence | General |  | Request to Charge |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.12.16 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Other Correspondence | General |  | Notification of Charging Under Treatment IND |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.12.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Other Correspondence | General |  | Request for Waiver |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.12.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Other Correspondence | General |  | Exemption from Informed Consent for Emergency Research |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.12.5 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Other Correspondence | General |  | Public Disclosure Statement for Emergency Care Research |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.12.6 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Other Correspondence | General |  | Correspondence Regarding Emergency Care Research |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.12.7 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Other Correspondence | General |  | Notification of Discontinuation of Clinical Trial |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.12.8 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Annual Report | USA |  | IND or NDA Annual Report |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.12.9 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Annual Report | USA |  | Summary for Nonclinical Studies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.13 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Annual Report | USA |  | Foreign marketing history |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.13.1 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Annual Report | USA |  | Distribution Data |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.13.10 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Annual Report | USA |  | Status of Postmarketing Study Commitments |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.13.11 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Annual Report | USA |  | Status of Other Postmarketing Studies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.13.12 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Annual Report | USA |  | Log of Outstanding Regulatory Business |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.13.13 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Annual Report | USA |  | Summary of Clinical Pharmacology Information |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.13.14 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Annual Report | USA |  | Summary of Safety Information |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.13.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Annual Report | USA |  | Summary of Manufacturing Changes |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.13.3 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Annual Report | USA |  | Summary of Microbiological Changes |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.13.5 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Annual Report | USA |  | Summary of Other Significant New Information |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.13.6 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Annual Report | USA |  | Individual Study Information |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.13.7 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Annual Report | USA |  | General Investigational Plan |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.13.8 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Labeling | USA |  | Label Comprehension Studies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.13.9 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Listed Drug Labeling | USA |  | Annotated Comparison with Listed Drug
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Promotional Material | USA |  | Promotional Materials
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Risk Management Plans | USA |  | Risk Management Plan |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.15 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Ad Hoc Regulatory safety Reports | USA |  | IND Safety Report
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Additional Data and Response to Questions | General |  | Responses to Questions
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Additional Data and Response to Questions | General |  | Additional Data |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.A |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Application Withdrawal | EU |  | MA Withdrawal or Cancellation |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.B |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Product Name and Classification | EU |  | [NAME] |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | N-A |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Regulatory Approval | EU |  | Medical Device Approval Certificate |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | N-A |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Regulatory Correspondence | EU |  | Compassionate Use |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | N-A |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Regulatory Submission EU CTA | EU |  | CTA Amendment |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | N-A |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Administrative Information | Administrative Information | USA |  | Financial Disclosure Information |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | N-A |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Summaries | General |  | Introduction |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | North America | USA | NDA | original-application | 0000 | REG-01 |  |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 |  |  |  |  |  |  |  |  |  |  |  | Submissable to: |  |  |  |  |  | Domain Specific -  Columns apply to '[NAME]' column |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Product Name | NOTE: At least one required
 | Process Zone | Domain | Group | Sub-Group | Region |  | Artifact Name | Notes | Definition |  | Is the artifact: Mandatory (M) / Recommended (R) / Extension of a Submission (E) or Optional (O) | US | EMEA | EU | JP | National |  | Labeling | Review / Approval Process Type | [NAME] | Regulatory Status Date | Product / package identifiers | Product Family | Product Class | Indication | Labeler(s) | Project | Based On | Source Labeling | Source Link | Key Changes | [NAME] | Reference Link | Artifact contents, human readable description | Internal Status | Interal Status Date | Publication Status | Publication Status Date | Flagged Statements | Layout identifiers ([NAME] codes) | Submission Document | Artifact id | Submission Date | Submission Description |  |  | Chemical Name | Compound ID | International Nonproprietary Name | Generic Name | Trade Name
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Annex II |  |  |  | M |  | X | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Blister Label |  |  |  | M |  | X | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Combined Label |  | Combined Blister, Immediate, Intermediate, [NAME] labels all of one strength |  | M |  | X | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Combined Product Information |  | Single EU submission document containing [NAME] I, Annex II and Annex III submitted as part of a Centralised Procedure |  | M |  | X | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Consolidated Combined Label |  | Multiple Combined Labels, one after another per strength |  | M |  | X | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Consolidated Patient Information Leaflet |  | Multiple Patient Information Leaflets concatentated, one after another per strength |  | M |  | X | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Consolidated SmPC |  | Multiple SmPC documents concatenated, one after another per strength |  | M |  | X | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Core Safeity Profile |  | Typically a European document that contains pertinent safety information from the Core Data Sheet |  | M |  | X | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Immediate Label |  |  |  | M |  | X | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Intermediate Label |  |  |  | M |  | X | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Outer Label |  |  |  | M |  | X | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Patient Information Leaflet |  |  |  | M |  | X | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Summary of Product Characteristics |  |  |  | M |  | X | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Company Core Data Sheet |  | The companies stance on a labeling document. Mostly refers to the Presribing Information or the Summary of Product Characteristics |  | E | X |  | X | X | X |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Company Core Safety Information |  | Typically a European document that contains pertinent safety information from the Core Data Sheet |  | E | X |  | X | X | X |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Core Patient Information leaflet |  | Company stance on mandatory information required for Patient Information Leaflet |  | E | X |  | X | X | X |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Developmental Core Data Sheet |  | Multiple developmental core data sheets are used to create the company core data sheet |  | O | X |  | X | X | X |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Readability Testing | [NAME] thinks this can also coinside with 1.3.4 Consultation with Target Patient Groups |  |  | R |  |  | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Target Product Profile |  | Target profile document used to create Developmental Core Data Sheets |  | R | X |  | X | X | X |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Local Label |  | Local label submitted which is submitted to non-US non-EU health authorities |  | M |  |  |  | X | X |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Consumer Brief Summary |  | Could be authored individually or as part of the SPL. Recommendation requested from committee on what to do, recommend method of construction |  | R | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Medication Guide |  | Could be authored individually or as part of the SPL. Recommendation requested from committee on what to do, recommend method of construction |  | R | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Package Insert |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Patient Instructions For Use |  | Could be authored individually or as part of the SPL. Recommendation requested from committee on what to do, recommend method of construction |  | R | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Patient Package Insert |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Prescribing Information |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Principal Display Panel |  | Could be authored individually or as part of the SPL. Recommendation requested from committee on what to do, recommend method of construction |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Professional Brief Summary |  | Could be authored individually or as part of the SPL. Recommendation requested from committee on what to do, recommend method of construction |  | R | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | SPL - Non-PLR |  |  |  | O | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | SPL - PLR |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Annotated Label |  | Prescribing information document that contains citations to the information that is the basis of the labeling statement. |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | [NAME] |  | Used in an ANDA to compare the current label to the reference label drug |  | O | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Supporting Labeling |  |  | [NAME] |  | A complete listing of all the changes made to a label document. |  | M | X |  | X | X | X |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Mock-Up |  | A ‘mock-up’ is a copy of the flat artwork design in full colour, presented so that, following cutting and folding where necessary, it provides a replica of both the outer and immediate packaging so that the three dimensional presentation of the label text is clear. |  | M |  |  | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Supporting Labeling |  |  | Negotiation Label |  | The track changed / marked up / annotated document that is sent back and forth between Health Authority during review.  EU is PDF and US is PDF, [NAME] and draft SPL file submitted for review with the Health Authority |  | M | X |  | X | X | X |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | [NAME] |  | A ‘specimen’ is a sample of the actual printed outer and immediate packaging materials and package leaflet (i.e. the sales presentation). |  | M |  |  | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Product Information already approved in the member state |  |  |  | M |  |  | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Braile |  |  |  | M |  |  | X |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Establishment Registration |  | Any establishment involved in the production and distribution of any pharmacetical product or medical devices intended for commercial distribution in the U.S.A are required to complete an Establishment Registration |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Estalishment |  | The Establishment information is the listing of the sites that help manufacture, label or package the product.  Establishment information is used in an Establishment Registration and within SPL in PLR Format. |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | NDC-Labeler Code |  | NDC Labeler Code Requests |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | Affordable Care Act  6004 |  | Currently draft guidance. [NAME] |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.1 [NAME] labeling |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.1.1 Draft carton and container labels |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.1.2 Annotated draft labeling text |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.1.3 [NAME] labeling text |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.1.4 Label comprehension studies |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.1.5 Labeling history |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.2 Final labeling |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.2.1 Final carton or container labels |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.2.2 Final package insert (package inserts, patient information, medication guides) |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.2.3 Final labeling text |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.3 Listed drug labeling |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.3.1 Annotated comparison with listed drug |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.3.2 Approved labeling text for listed drug |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.3.3 Labeling text for reference listed drug |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.4 Investigational drug labeling |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.4.1 Investigational brochure |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.4.2 Investigational drug labeling |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.5 Foreign labeling |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Regulatory-Submission | Labeling | Labeling | Labeling |  |  | 1.14.6 Product labeling for 2253 submissions |  |  |  | M | X |  |  |  |  |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..*) | O (0..1) | O (0..*) | O (0..*) | O (*..1) | O (0..*) | O (0..*) | O (*..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..*) | O (0..1) | O (0..1) | M (1..1) | O (0..1) | O (0..1) |  |  | O (0..1) | O (0..1) | O (0..1) | O (0..1) | O (0..1)
 | Process Zone | Domain | Group | Sub-Group | Sub-Group |  | Artifact Name |  |  | Domain Specific - Columns apply to '[NAME]' column |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Product Name | NOTE: At least one required |  |  |  |  | Content Management |  |  |  |  |  |  |  | Document Management
 | Regulatory-Submission | Quality | Drug Substance | Characterization | General |  | General Information |  |  | QUALITY | DS Name | Manuf | Formulation | Mfg Process | Impurity | Batch Number | Container Closure | Controlled Document# | DP Name | Dosage Form | Dosage Strength |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Region | Submission Country | Application Type | Submission Type | Procedure Type | Transaction | CTD/Section | Project | Submit Date |  |  | Chemical Name | Compound ID | Generic Name | Trade Name |  |  | Author | Business Owner | Component Name | Contributor | Document Title | Issued Date |  |  | Creation Date | Creator | Language | Litigation Hold | Modify Date | Status | Version Label | Version Number
 | Regulatory-Submission | Quality | Drug Substance | Characterization | General |  | Nomenclature |  |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.1
 | Regulatory-Submission | Quality | Drug Substance | Characterization | General |  | Structure |  |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.1.1
 | Regulatory-Submission | Quality | Drug Substance | Characterization | General |  | General Properties |  |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.1.2
 | Regulatory-Submission | Quality | Drug Substance | Characterization | General |  | Elucidation of Structure and Other Characteristics |  |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.1.3
 | Regulatory-Submission | Quality | Drug Substance | Characterization | General |  | Impurities - Drug Substance |  |  |  | M | M |  | O |  | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.3.1
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Manufacturers - Drug Substance |  |  |  | M | M |  | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.3.2
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Description of the Drug Substance Manufacturing Process |  |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.2.1
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Control of Materials |  |  |  | M | M |  | M |  |  |  | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.2.2
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Cell Line Development (Biotech) |  |  |  | M | M |  | M |  |  |  | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.2.3
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Cell Bank Testing (Biotech) |  |  |  | M | M |  | M |  | M |  | O
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Control of Critical Steps and Intermediates - Drug Substance |  |  |  | M | M |  | M |  | M |  | M
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Process Validation and/or Evaluation - Drug Substance |  |  |  | M | M |  | M |  | M |  | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.2.4
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Drug Substance Manufacturing Development |  |  |  | M | M |  | M |  | M | O | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.2.5
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Executed Production Record - Drug Substance |  |  |  | M | M |  | M |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.2.6
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | Specifications - Drug Substance |  |  |  | M | M |  | M |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R.1
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | Analytical Procedures - Drug Substance |  |  |  | M | M |  |  |  |  |  | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.4.1
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | Assay - Drug Substance (Example of recommended granularity) |  |  |  | M | M |  |  | O |  |  | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.4.2
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | HPLC of Drug Substance Impurities (Example of recommended granularity)
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | Validation of Analytical Proceduress - Drug Substance
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | [NAME] |  |  |  | M | M |  |  | O | M |  | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.4.3
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | Justification of Specifications - Drug Substance |  |  |  | M | M |  | M | O | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.4.4
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | Reference Standards or Materials - Drug Substance |  |  |  | M | M |  | O | O | M | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.4.5
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | Method Validation Package - Drug Substance |  |  |  | M | M |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.5
 | Regulatory-Submission | Quality | Drug Substance | Container Closure | General |  | Container Closure Specifications, QC Testing - Drug Substance |  |  |  | M | M |  |  |  | M |  | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R.3
 | Regulatory-Submission | Quality | Drug Substance | Container Closure | General |  | Suitability Studies - Drug Substance Container Closure |  |  |  | M | M |  |  |  |  | M | M
 | Regulatory-Submission | Quality | Drug Substance | Stability | General |  | Stability Summary and Conclusions - Drug Substance |  |  |  | M | M |  |  |  | M | M | M
 | Regulatory-Submission | Quality | Drug Substance | Stability | General |  | Postapproval Stability Protocol and Stability Commitment - Drug Substance | wording to Post approval, but need verification |  |  | M | M |  | M | O | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.7.1
 | Regulatory-Submission | Quality | Drug Substance | Stability | General |  | Stability Data - Drug Substance |  |  |  | M | M |  | M |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.7.2
 | Regulatory-Submission | Quality | Drug Substance | Stability | General |  | Primary Stability Data (Optional granularity) |  |  |  | M | M |  | M | O | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.7.3
 | Regulatory-Submission | Quality | Drug Substance | Stability | General |  | Supportive Stability Data (Optional granularity)
 | Regulatory-Submission | Quality | Drug Substance | Stability | General |  | Forced Degradation Studies (Optional granularity)
 | Regulatory-Submission | Quality | Drug Substance | Stability | General |  | Stability of Intermediates (Optional granularity)
 | Regulatory-Submission | Quality | Drug Substance | Comparability Protocols | General |  | Comparability protocols
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Substance | General |  | General Information - Summary |  |  |  | M | M |  | M |  |  |  | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R.2
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Substance | General |  | Drug Substance Manufacture - Summary |  |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.S.1
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Substance | General |  | Drug Substance Characterization - Summary |  |  |  | M | M |  | M |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.S.2
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Substance | General |  | Control of Drug Substance - Summary |  |  |  | M | M |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.S.3
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Substance | General |  | Drug Substance Reference Standards or Materials - Summary |  |  |  | M | M |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.S.4
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Substance | General |  | Drug Substance Container Closure System - summary |  |  |  | M | M |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.S.5
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Substance | General |  | Drug Substance Stability - Summary |  |  |  | M | M |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.S.6
 | Regulatory-Submission | Quality | Drug Substance | Drug Master Files | USA |  | Drug Master File Facility A (recommended granularity) |  |  |  | M | M |  | M |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.S.7
 | Regulatory-Submission | Quality | Drug Product | Drug Master Files | USA |  | Drug Master File Facility B, etc. (recommended granularity) |  |  |  | M | M |  | M |  |  | M
 | Regulatory-Submission | Quality | Drug Product | Composition | General |  | Description and Composition |  |  |  | M | M |  | M |  |  | M
 | Regulatory-Submission | Quality | Drug Product | Pharmaceutical Development | General |  | Components |  |  |  | M | M |  |  |  |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.1
 | Regulatory-Submission | Quality | Drug Product | Pharmaceutical Development | General |  | Formulation Development |  |  |  | M | M |  |  |  |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.2.1
 | Regulatory-Submission | Quality | Drug Product | Pharmaceutical Development | General |  | Drug Product Manufacturing Process Development |  |  |  | M | M | M |  |  |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.2.2
 | Regulatory-Submission | Quality | Drug Product | Pharmaceutical Development | General |  | Drug Product Container Closure Development |  |  |  | M | M |  | M |  | M | M |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.2.3
 | Regulatory-Submission | Quality | Drug Product | Pharmaceutical Development | General |  | Microbiological Attributes |  |  |  | M | M |  |  |  |  | M |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.2.4
 | Regulatory-Submission | Quality | Drug Product | Pharmaceutical Development | General |  | Compatibility |  |  |  | M | M |  |  |  |  | M |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.2.5
 | Regulatory-Submission | Quality | Drug Product | Manufacture | General |  | Manufacturer(s) - Drug Product |  |  |  | M | M |  |  |  |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2,P.2.6
 | Regulatory-Submission | Quality | Drug Product | Manufacture | General |  | [NAME]) |  |  |  | M | M |  |  |  |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.3.1
 | Regulatory-Submission | Quality | Drug Product | Manufacture | General |  | Description of the Drug Product Manufacturing Process |  |  |  | M | M | M | M |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.3.2
 | Regulatory-Submission | Quality | Drug Product | Manufacture | General |  | Control of Critical Steps and Intermediate(s) - Drug Product |  |  |  | M | M | M | M |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.3.3
 | Regulatory-Submission | Quality | Drug Product | Manufacture | General |  | Process Validation and/or Evaluation - Drug Product |  |  |  | M | M |  | M |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.3.4
 | Regulatory-Submission | Quality | Drug Product | Manufacture | General |  | Executed Production Record - Drug Product |  |  |  | M | M |  | M |  | M | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.3.5
 | Regulatory-Submission | Quality | Drug Product | Excipients | General |  | Specifications for Excipients |  |  |  | M | M | M | M |  | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R.1.P
 | Regulatory-Submission | Quality | Drug Product | Excipients | General |  | Analytical Procedures - Excipients |  |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.4.1
 | Regulatory-Submission | Quality | Drug Product | Excipients | General |  | Validation of Analytical Procedures - Excipients |  |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.4.2
 | Regulatory-Submission | Quality | Drug Product | Excipients | General |  | Justification of Specification - Excipients |  |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.4.3
 | Regulatory-Submission | Quality | Drug Product | Excipients | General |  | Excipients of Biological Origin |  |  |  | M | M |  |  |  | O |  | O | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.4.4
 | Regulatory-Submission | Quality | Drug Product | Excipients | General |  | Novel Excipients |  |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.4.5
 | Regulatory-Submission | Quality | Drug Product | Excipients | General |  | Novel Excipients Appendix |  |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.4.6
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | Specifications |  |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.A.2
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | Analytical Procedures - Drug Product |  |  |  | M | M |  |  | O |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.5.1
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | Assay (Recommended granularity) |  |  |  | M | M |  |  | O |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.5.2
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | HPLC of Impurities, etc.(Recommended granularity)
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | Validation of Analytical Procedures - Drug Product
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | Batch Analysis - Drug Product |  |  |  | M | M |  |  | O | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.5.3
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | Characterization of Drug Product Iimpurities |  |  |  | M | M | M | M | O | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.5.4
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | Justification of Specification - Drug Product |  |  |  | M | M | M | M | O | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.5.5
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | Method Validation Package - Drug Product |  |  |  | M | M | M | M | O | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.5.6
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | [NAME] |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R.3
 | Regulatory-Submission | Quality | Drug Product | Container Closure | General |  | Container Closure - Drug Product |  |  |  | M | M | M | M | O | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.6
 | Regulatory-Submission | Quality | Drug Product | Stability | General |  | Drug Product Stability Summary and Conclusions |  |  |  | M | M |  |  |  |  | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.7
 | Regulatory-Submission | Quality | Drug Product | Stability | General |  | Postapproval Stability Protocol and Stability Commitment - Drug Product |  |  |  | M | M | M | M | O | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.8.1
 | Regulatory-Submission | Quality | Drug Product | Stability | General |  | Drug Product Stability Data |  |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.8.2
 | Regulatory-Submission | Quality | Drug Product | Stability | General |  | Primary Stability Data (Optional granularity) |  |  |  | M | M | M | M | O | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.8.3
 | Regulatory-Submission | Quality | Drug Product | Stability | General |  | Supportive Stability Data (Optional granularity)
 | Regulatory-Submission | Quality | Drug Product | Stability | General |  | Forced Degradation Studies (Optional granularity)
 | Regulatory-Submission | Quality | Drug Product | Stability | General |  | In-Use Stability (Optional granularity)
 | Regulatory-Submission | Quality | Drug Product | Stability | General |  | Stability of Intermediates (Optional granularity)
 | Regulatory-Submission | Quality | Drug Product | Comparability Protocols | General |  | Comparability protocols
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Product | General |  | Description and Composition of the Drug Product - Summary |  |  |  | M | M |  | M |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R.2
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Product | General |  | Pharmaceutical Development - Summary |  |  |  | M | M | M | M |  |  | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.P.1
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Product | General |  | Manufacture of Drug Product - Summary |  |  |  | M | M | M | M |  | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.P.2
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Product | General |  | Excipients - Summary |  |  |  | M | M | M | M |  | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.P.3
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Product | General |  | Control of Drug Product - Summary |  |  |  | M | M | M |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.P.4
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Product | General |  | Drug Product Reference Standard(s) - Summary |  |  |  | M | M |  | M | O | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.P.5
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Product | General |  | Drug Product Container Closure System - Summary |  |  |  | M | M | M | M |  | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.P.6
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Product | General |  | Drug Product Stability - Summary |  |  |  | M | M |  |  |  |  | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.P.7
 | Regulatory-Submission | Quality | Drug Substance | Facilities and Equipment | USA |  | Facility A (recommended granularity) |  |  |  | M | M | M | M |  | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.P.8
 | Regulatory-Submission | Quality | Drug Product | Facilities and Equipment | USA |  | Facility B (recommended granularity) |  |  |  | M | M |  | M |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.A.1
 | Regulatory-Submission | Quality | Quality Overall Summary | Facilities and Equipment | USA |  | Facilities and Equipment Quality Overall Summary |  |  |  | M | M |  | M |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.A.1
 | Regulatory-Submission | Quality | Adventitious Agents | Safety Evaluation | USA |  | TSE/BSE Documentation (Optional granularity) |  |  |  | M | M |  | M |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.A.1
 | Regulatory-Submission | Quality | Adventitious Agents | Safety Evaluation | USA |  | Virus Testing (Optional granularity) |  |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.A.2
 | Regulatory-Submission | Quality | Adventitious Agents | Safety Evaluation | USA |  | Viral Clearance |  |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.A.2
 | Regulatory-Submission | Quality | Adventitious Agents | Safety Evaluation | USA |  | Other Adventitious Agents |  |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.A.2
 | Regulatory-Submission | Quality | Adventitious Agents | Safety Evaluation | USA |  | Adventitious Agents Quality Overall Summary |  |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.A.2
 | Regulatory-Submission | Quality | Drug Product | Regional | EU |  | Process Validation Scheme (EU) |  |  |  | M | M |  |  |  |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.A.2
 | Regulatory-Submission | Quality | Medical Device | Regional | EU |  | Medical Device (EU) |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R
 | Regulatory-Submission | Quality | Quality Information | Annual Report | USA |  | Annual Report - Summary of Manufacturing Changes |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R
 | Regulatory-Submission | Quality | Quality Information | Annual Report | USA |  | Annual Report - Summary of Microbiological Changes
 | Regulatory-Submission | Quality | Quality Information | Annual Report | USA |  | Annual Report - Distribution Data
 | Regulatory-Submission | Quality | Quality Information | Amendment | General |  | Quality Information Amendment
 | Regulatory-Submission | Quality | Literature References | Quality Literature References | ? |  | Quality Literature References |  | In Quality [NAME] but not listed here
 | Process Zone | Domain | Group | Sub-Group | Sub-Group |  | Artifact Name |  |  | Domain Specific - Columns apply to '[NAME]' column |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Product Name | NOTE: At least one required |  |  |  |  | Content Management |  |  |  |  |  |  |  | Document Management
 | Regulatory-Submission | Non-Clinical | Non-Clinical Study Reports | Non-Clinical Study Reports | General |  |  |  |  | NON-CLIN | Study# | Study Type | Study Director | Dosage Strength | Dosage Form | Test Facility Location | Route-of-Admin | Duration | GLP | Species |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Region | Submission Country | Application Type | Submission Type | Procedure Type | Transaction | CTD/Section | Project | Submit Date |  |  | Chemical Name | Compound ID | Generic Name | Trade Name |  |  | Author | Business Owner | Component Name | Contributor | Document Title | Issued Date |  |  | Creation Date | Creator | Language | Litigation Hold | Modify Date | Status | Version Label | Version Number
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Pharmacology | General |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Audit certifications and report | Audit certifications and report |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.1
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Contributing scientist reports/signatures | Contributing scientist reports/signatures |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Data Appendices (possibly organized by type) | Data Appendices (possibly organized by type) |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Drug concentration data | Drug concentration data |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Figures | Figures |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Individual animal data listings | Individual animal data listings | Publications based on the study |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Key Personnel List (supervisory personnel involved w/study) | Key Personnel List (supervisory personnel involved w/study) | Compliance and/or drug concentration data |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Legacy study report | Legacy study report |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Other study data | Other study data |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Protocol deviations | Protocol deviations |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Protocol/amendments | Protocol/amendments |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Publications based on study | Publications based on study |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Statistical analysis run on study (occasionally this is included as a separate appendix) | Statistical analysis run on study (occasionally this is included as a separate appendix) |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Study report amendment | Study report amendment |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Study report body | Study report body |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Summary animal data listings | Summary animal data listings |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | Synopsis/abstract | Synopsis/abstract |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Secondary Pharmacodynamics | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Safety Pharmacology | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.1.2 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Pharmacodynamic Drug Interactions | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.1.3 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacokinetics Study Reports | Pharmacokinetics | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.1.4 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacokinetics Study Reports | Analytical Methods and Validation Reports | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.2 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacokinetics Study Reports | Absorption | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.2.1 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacokinetics Study Reports | Distribution | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.2.2 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacokinetics Study Reports | Metabolism | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.2.3 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacokinetics Study Reports | Excretion | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.2.4 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacokinetics Study Reports | Pharmacokinetic Drug Interactions | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.2.5 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Pharmacokinetics Study Reports | Other Pharmacokinetic Studies | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.2.6 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Toxicology | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.2.7 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Single dose toxicity | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Repeat dose toxicity | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.1 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Genotoxicity | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.2 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Genotoxicity | General |  | In vitro |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.3 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Genotoxicity | General |  | In vivo |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.3.1 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Carcinogenicity | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.3.2 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Carcinogenicity | General |  | Long term studies |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.4 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Carcinogenicity | General |  | Short or medium term studies |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.4.1 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Carcinogenicity | General |  | Other studies |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.4.2 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Reproductive and developmental toxicity | General |  | Reproductive and developmental toxicity |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.4.3 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Reproductive and developmental toxicity | General |  | Fertility and early embryonic development |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.5 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Reproductive and developmental toxicity | General |  | Embryofetal development |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.5.1 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Reproductive and developmental toxicity | General |  | Prenatal and postnatal development, including maternal fucntionality |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.5.2 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Reproductive and developmental toxicity | General |  | Studies in which the offspring (juvenile animals) are dosed and/or further evaluated |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.5.3 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Local tolerance | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.5.4 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Other toxicity studies | General |  | Other toxicity studies |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.6 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Antigenicity | General |  | Antigenicity |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.7 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Immunotoxicity | General |  | Immunotoxicity |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.7.1 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Mechanistic studies | General |  | Mechanistic studies |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.7.2 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Dependence | General |  | Dependence |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.7.3 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | [NAME] | General |  | [NAME] |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.7.4 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Impurities | General |  | Impurities |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.7.5 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Toxicology Study Reports | Other | General |  | Other |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.7.6 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Literature References | Literature References | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.7.7 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Summary documents | General |  |  |  |  |  | M | O | M | M | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.3 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Nonclinical Overview |  | Nonclinical Overview
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Nonclinical Summary |  | Nonclinical Summary |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.4 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Introduction |  | Introduction |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Pharmacology Written Summary |  | Pharmacology Written Summary |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.1 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Pharmacology Tabulated Summaries |  | Pharmacology Tabulated Summaries |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.2 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Pharmacokinetics Written Summary |  | Pharmacokinetics Written Summary |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.3 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Pharmacokinetics Tabulated Summaries |  | Pharmacokinetics Tabulated Summaries |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.4 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Toxicology Written Summary |  | Toxicology Written Summary |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.5 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Toxicology Tabulated Summaries |  | Toxicology Tabulated Summaries |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.6 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Toxicology Overview |  | Toxicology Overview |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.7 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Toxicokinetics Studies & Data |  | Toxicokinetics Studies & Data |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.7.1 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Toxicology Drug Substance |  | Toxicology Drug Substance |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.7.2/3 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Single-Dose Toxicity |  | Single-Dose Toxicity |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.7.4 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Repeat-Dose Toxicity |  | Repeat-Dose Toxicity |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.7.5 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Genotoxicity |  | Genotoxicity |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.7.6/7 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Carcinogenicity |  | Carcinogenicity |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.7.8/9 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Reproductive and Developmental Toxicity |  | Reproductive and Developmental Toxicity |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.7.10 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Local Tolerance |  | Local Tolerance |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.7.11-15 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Other Toxicity Studies |  | Other Toxicity Studies |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.7.16 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 |  |  |  |  |  |  |  |  |  |  | M | O | O | O | O | O | O | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.6.7.17 |  |  |  |  | M | M | O | O |  |  | M | M | M | O | M | M |  |  | M | M | M | M | M | M | M | M
 | Process Zone | Domain | Group | Sub-Group | Sub-Group |  | Artifact Name |  |  | Domain Specific - Columns apply to '[NAME]' column |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Product Name | NOTE: At least one required |  |  |  |  | Content Management |  |  |  |  |  |  |  | Document Management
 | Regulatory-Submission | Clinical |  |  |  |  | Information relating to Clinical Trials |  |  | CLINICAL | Indication | Clinical Study # | Clinical Study Title | Route of Admin | Study Phase | Clinical Trial Indentifier | Type of Control | Site Identifier | [NAME] | eCTD STF Tag Elem. |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Region | Submission Country | Application Type | Submission Type | Procedure Type | Transaction | CTD/Section | Project | Submit Date |  |  | Chemical Name | Compound ID | Generic Name | Trade Name |  |  | Author | Business Owner | Component Name | Contributor | Document Title | Issued Date |  |  | Creation Date | Creator | Language | Litigation Hold | Modify Date | Status | Version Label | Version Number
 | Regulatory-Submission | Clinical | Summaries | Overview | General |  | Clinical Overview |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [NAME] | emea | MAA | initial-maa | centralised | 0000 | 1.9 | [NAME] |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Clinical | Summaries | Biopharmaceutic Studies and Analytical Methods | General |  | Summary of Biopharmaceutic Studies and Analytical Methods |  |  |  | M
 | Regulatory-Submission | Clinical | Summaries | Clinical Pharmacology Studies | General |  | Summary of Clinical Pharmacology Studies |  |  |  | M
 | Regulatory-Submission | Clinical | Summaries | Clinical Efficacy | General |  | Summary of Clinical Efficacy |  |  |  | M
 | Regulatory-Submission | Clinical | Summaries | Clinical Safety | General |  | Summary of Clinical Safety |  |  |  | M
 | Regulatory-Submission | Clinical | Summaries | References | General |  | References |  |  |  | M
 | Regulatory-Submission | Clinical | Summaries | Synopsis | General |  | Synopses of individual studies |  |  |  | M
 | Regulatory-Submission | Clinical | Summaries | ISS | USA |  | Integrated Summary of Safety |  |  |  | M
 | Regulatory-Submission | Clinical | Summaries | ISE | USA |  | Integrated Summary of Efficacy |  |  |  | M |  |  |  |  |  |  |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports | Clinical Study Report | General |  | Legacy clinical study report |  |  |  | M |  |  |  |  |  |  |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports | Synopsis | General |  | Synopsis |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Report body |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Statistical output |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Full protocol |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Protocol amendment |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports | Case Report Forms | General |  | Sample CRF |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | List of IECs and IRBs |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Informed consent |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | List and description of investigators and sites |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Signature page |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | List of patients receiving test drug |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Data Monitoring Committee |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Data management plan |  |  |  | M | M | M | M | M | M | M |  |  | ?
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Randomization scheme |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Audit certificates report |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Statistical analysis plan |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Interlaboratory standardization methods |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Publications based on study |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Investigator CVs |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Publication |  |  |  | M | M | M | M | M | M | M | M |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Patient data listing |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Discontinued Patients Listing |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Protocol Deviation Listing |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | [NAME] from Efficacy Analysis Listing |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Demographic Data Listing |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Compliance and/or Drug Concentration Data Listing |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Individual Efficacy Response Data Listing |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Adverse Event Listings |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Individual Laboratory Measurements Listing |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports | Case Report Forms | USA |  | CRF |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports | Datasets | USA |  | Data tabulation dataset |  |  |  | M | M | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Clinical | Clinical Study Reports | Data Definitions | USA |  | Data definitions for data tabulation |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports | Datasets | USA |  | Datasets |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports | Datasets | USA |  | Data listing dataset |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports | Datasets | USA |  | Data definitions for data listing datasets |  |  |  | M | M | M | M | M | M | M |  |  | M
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 | Regulatory-Submission | Clinical | Clinical Study Reports |  | USA |  | Program file for analysis dataset |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports | Data Definitions | USA |  | Data definition for analysis datasets |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports | Case Report Forms | USA |  | Annotated CRF |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | USA |  | Annotated ECG waveform dataset |  |  |  | M | M | M | M | M | M | M |  |  | M
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 | Regulatory-Submission | Clinical | Clinical Study Reports |  | USA |  | Subject profiles |  |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | USA |  | IND safety report |  |  |  | M | M | M | M | M | M | M | M | M | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | USA |  | Individual subject data listing |  |  |  | M | M | M | M | M | M | M |  |  | M
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