Spreadsheet: d941b781-bd0c-4d53-908d-8ecb7e0dc800
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..*)