Spreadsheet: 608806d0-eba0-4c48-9f6b-8012c74da858
Sheet: Sheet1

Unnamed: 0 | Pharmaceutical Content Architecture | Unnamed: 2 | Date: | Unnamed: 4 | Unnamed: 5 | Unnamed: 6 | Unnamed: 7 | Unnamed: 8 | Unnamed: 9 | 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
 | Context of Use: | Regulatory Submission | 2009-10-30 00:00:00 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Entity | Attribute Label
Document Taxonomy |  |  |  |  |  |  |  |  | Domain Specific - Columns apply to '[NAME]' column |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Product Name | NOTE: At least one required |  |  |  |  | Content Management |  |  |  |  |  |  |  | Document Management
 | Process Zone | Domain | Group | Sub-Group | Region |  | Artifact Name |  | 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
 |  |  |  |  |  |  | Work in progress |  | PRESCRIBE | Indication
 |  |  |  |  |  |  |  |  | QUALITY | DS Name | Manuf | Formulation | Mfg Process | Impurity | Batch Number | Container Closure | Controlled Document# | DP Name | Dosage Form | Dosage Strength
 |  |  |  |  |  |  |  |  | NON-CLIN | Study# | Study Type | Study Director | Dosage Strength | Dosage Form | Test Facility Location | Route-of-Admin | Duration | GLP | Species
 | Process Zone | Domain | Group | Sub-Group | Region |  | Artifact Name |  | 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.
Document Taxonomy |  |  |  |  |  |  |  |  | Domain Specific - Columns apply to '[NAME]' column |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | NOTE: Inherited from submission management elements |  |  |  |  |  |  |  | Product Name | NOTE: At least one required |  |  |  |  | Content Management |  |  |  |  |  |  |  | Document Management
 | Process Zone | Domain | Group | Sub-Group | Region |  | Artifact Name |  | 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 | Cover Letter | General |  | Cover Letter |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [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 | Administrative Information | Table of Contents | General |  | Table of Contents |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [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 | General |  | Application Form |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 1571 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 356h |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 3397 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 2252 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 2253 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | USA |  | FDA Form 2567 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Renewal 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 | 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 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [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 |  | Informed consent letter of marketing authorisation holder of authorised medicinal product |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 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 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 1.3.1.1 |  |  |  |  | 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 | Sponsor Agent | General |  | Change of Agent |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | Applicant Information | General |  | Sponsor Change |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Transfer of Obligation |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | Applicant Information | Contact-Sponsor-Applicant Information | General |  | Change of Ownership of an Application |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Field Copy 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 |  | Debarment Certification |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | Administrative Information | USA |  | Financial Disclosure Cover Note |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 Information |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Patent Certifications |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | Patent and Exclusivity | USA |  | Exclusivity Request |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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-Quality |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [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-Non-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 | Information about the Experts | EU |  | Information about the Experts-Clinical |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [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 |  | Letter of Authorization |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Statement of Right to 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 |  | List of Authorized to Persons to Incorporate by Reference |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | References | General |  | Cross Reference to Other 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 Bibliographical 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 |  | Information for Generic, 'Hybrid' or Bio-similar Applications |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | (Extended) Data or Market Exclusivity |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Exceptional Circumstances |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | Administrative Information | Specific Requirements for Different Types of Applications | EU |  | Conditional Marketing Authorisation |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Withdrawal 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 |  | Inactivation 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 |  | Reactivation 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 | General |  | Reinstatement request |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | USA |  | Withdrawal of an unapproved NDA |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Withdrawal of a listed drug |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | Application Status | General |  | Request for withdrawal of application approval |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 - Non-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 | Applicant Information | Environmental Risk Assessment | EU |  | Environmental Risk Assessment - GMO |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Meeting Request |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | [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 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Meeting Background Materials |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Regulatory Correspondence |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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-Similarity |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | Information relating to Orphan Market Exclusivity | EU |  | [NAME] Market Exclusivity-Market Exclusivity |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | USA |  | Fast Track Designation Request |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 Designation Withdrawal Request | USA |  | Fast Track Designation Request Withdrawal |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | USA |  | Rolling Review Request |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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-Clinical 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-Carcinogenicity 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 | Applicant Information | Special Protocol Assessment Request | USA |  | Special Protocol Assessment Request-Stability Study |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 Waiver 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 Deferral of Pediatric Studies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Request for Pediatric Exclusivity Determination |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Proposed Pediatric Study Request and Amendments |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Proposal for Written Agreement |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | Pediatric Administrative Information | USA |  | Other Correspondence Regarding Pediatric Exclusivity or Study Plans |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Request for 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 | Administrative Information | Dispute Resolution | USA |  | Correspondence Related to Dispute Resolution |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Multiple Module 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 |  | Quality 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 (info not covered under modules 2-5) | EU |  | Safety 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 | Applicant Information | Information Amendment | EU |  | Efficacy Information Amendment |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Generic Drug Enforcement Act 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 |  | Basis for Submission Statement |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Comparison of Generic Drug and Reference Listed Drug |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 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 for Waiver for In Vivo Bioavalability Studies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Request to Charge |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Notification of Charging Under Treatment IND |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Request for Waiver |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Exemption from Informed Consent for Emergency 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 |  | Public Disclosure Statement for 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 |  | Correspondence Regarding Emergency Care Research |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | Administrative Information | Other Correspondence | General |  | Notification of Discontinuation of Clinical Trial |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | IND or NDA Annual Report |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Summary for Nonclinical Studies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Foreign marketing history |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Distribution Data |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 Postmarketing Study Commitments |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Status of Other Postmarketing Studies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Log of Outstanding Regulatory Business |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 Clinical Pharmacology 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 Safety Information |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 Manufacturing 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 Microbiological Changes |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 |  | Summary of Other Significant New 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 |  | Individual Study Information |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | Annual Report | USA |  | General Investigational Plan |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | Labeling | USA |  | Label Comprehension Studies
 | 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 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | Risk Management Plans | USA |  | Risk Management Plan
 | 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 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | Additional Data and Response to Questions | General |  | Additional Data |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | Application Withdrawal | EU |  | MA Withdrawal or Cancellation |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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 | 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 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 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
 | Regulatory-Submission | Regulatory/Admin | Applicant Information | Summaries | General |  | Introduction |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.2 |  |  |  |  | O | O(0..*) | O(0..*) | O(0..*) |  |  | O | M | M | O | O | M |  |  | M | M | M | M | M | M | M | M
 |  |  |  |  |  |  |  |  | Domain Specific - Columns apply to '[NAME]' column |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Product Name | NOTE: At least one required |  |  |  |  | Content Management |  |  |  |  |  |  |  | Document Management
 | Process Zone | Domain | Group | Sub-Group | Sub-Group |  | Artifact Name |  | 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 |  | General Information |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.1
 | Regulatory-Submission | Quality | Drug Substance | Characterization | General |  | Nomenclature |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.1.1
 | Regulatory-Submission | Quality | Drug Substance | Characterization | General |  | Structure |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.1.2
 | Regulatory-Submission | Quality | Drug Substance | Characterization | General |  | General Properties |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.1.3
 | Regulatory-Submission | Quality | Drug Substance | Characterization | General |  | Elucidation of Structure and Other Characteristics |  |  | M | M |  | O |  | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.3.1
 | Regulatory-Submission | Quality | Drug Substance | Characterization | General |  | Impurities - Drug Substance |  |  | M | M |  | O | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.3.2
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Manufacturers - Drug Substance |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.2.1
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Description of the Drug Substance Manufacturing Process |  |  | M | M |  | M |  |  |  | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.2.2
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Control of Materials |  |  | M | M |  | M |  |  |  | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.2.3
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Cell Line Development (Biotech) |  |  | M | M |  | M |  | M |  | O
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Cell Bank Testing (Biotech) |  |  | M | M |  | M |  | M |  | M
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Control of Critical Steps and Intermediates - Drug Substance |  |  | M | M |  | M |  | M |  | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.2.4
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Process Validation and/or Evaluation - Drug Substance |  |  | M | M |  | M |  | M | O | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.2.5
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Drug Substance Manufacturing Development |  |  | M | M |  | M |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.2.6
 | Regulatory-Submission | Quality | Drug Substance | Manufacture | General |  | Executed Production Record - Drug Substance |  |  | M | M |  | M |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R.1
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | Specifications - Drug Substance |  |  | M | M |  |  |  |  |  | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.4.1
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | Analytical Procedures - Drug Substance |  |  | M | M |  |  | O |  |  | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.4.2
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | Assay - Drug Substance (Example of recommended granularity)
 | 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 |  |  | M | M |  |  | O | M |  | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.4.3
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | [NAME] |  |  | M | M |  | M | O | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.4.4
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | Justification of Specifications - Drug Substance |  |  | M | M |  | O | O | M | O | O |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.4.5
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | Reference Standards or Materials - Drug Substance |  |  | M | M |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.5
 | Regulatory-Submission | Quality | Drug Substance | Controls | General |  | Method Validation Package - Drug Substance |  |  | M | M |  |  |  | M |  | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R.3
 | Regulatory-Submission | Quality | Drug Substance | Container Closure | General |  | Container Closure Specifications, QC Testing - Drug Substance |  |  | M | M |  |  |  |  | M | M
 | Regulatory-Submission | Quality | Drug Substance | Container Closure | General |  | Suitability Studies - Drug Substance Container Closure |  |  | M | M |  |  |  | M | M | M
 | Regulatory-Submission | Quality | Drug Substance | Stability | General |  | Stability Summary and Conclusions - Drug Substance |  |  | M | M |  | M | O | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.7.1
 | Regulatory-Submission | Quality | Drug Substance | Stability | General |  | Postapproval Stability Protocol and Stability Commitment - Drug Substance |  |  | M | M |  | M |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.7.2
 | Regulatory-Submission | Quality | Drug Substance | Stability | General |  | Stability Data - Drug Substance |  |  | M | M |  | M | O | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.S.7.3
 | Regulatory-Submission | Quality | Drug Substance | Stability | General |  | Primary Stability Data (Optional granularity)
 | 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 |  |  | M | M |  | M |  |  |  | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R.2
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Substance | General |  | General Information - Summary |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.S.1
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Substance | General |  | Drug Substance Manufacture - Summary |  |  | M | M |  | M |  |  | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.S.2
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Substance | General |  | Drug Substance Characterization - Summary |  |  | M | M |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.S.3
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Substance | General |  | Control of Drug Substance - Summary |  |  | M | M |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.S.4
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Substance | General |  | Drug Substance Reference Standards or Materials - Summary |  |  | M | M |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.S.5
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Substance | General |  | Drug Substance Container Closure System - summary |  |  | M | M |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.S.6
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Substance | General |  | Drug Substance Stability - Summary |  |  | M | M |  | M |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.S.7
 | Regulatory-Submission | Quality | Drug Substance | Drug Master Files | USA |  | Drug Master File Facility A (recommended granularity) |  |  | M | M |  | M |  |  | M
 | 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 | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.1
 | Regulatory-Submission | Quality | Drug Product | Pharmaceutical Development | General |  | Components |  |  | M | M |  |  |  |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.2.1
 | Regulatory-Submission | Quality | Drug Product | Pharmaceutical Development | General |  | Formulation Development |  |  | M | M | M |  |  |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.2.2
 | Regulatory-Submission | Quality | Drug Product | Pharmaceutical Development | General |  | Drug Product Manufacturing Process Development |  |  | M | M |  | M |  | M | M |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.2.3
 | Regulatory-Submission | Quality | Drug Product | Pharmaceutical Development | General |  | Drug Product Container Closure Development |  |  | M | M |  |  |  |  | M |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.2.4
 | Regulatory-Submission | Quality | Drug Product | Pharmaceutical Development | General |  | Microbiological Attributes |  |  | M | M |  |  |  |  | M |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.2.5
 | Regulatory-Submission | Quality | Drug Product | Pharmaceutical Development | General |  | Compatibility |  |  | M | M |  |  |  |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2,P.2.6
 | Regulatory-Submission | Quality | Drug Product | Manufacture | General |  | Manufacturer(s) - Drug Product |  |  | M | M |  |  |  |  |  |  | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.3.1
 | Regulatory-Submission | Quality | Drug Product | Manufacture | General |  | [NAME]) |  |  | M | M | M | M |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.3.2
 | 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.3.3
 | Regulatory-Submission | Quality | Drug Product | Manufacture | General |  | Control of Critical Steps and Intermediate(s) - Drug Product |  |  | M | M |  | M |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.3.4
 | Regulatory-Submission | Quality | Drug Product | Manufacture | General |  | Process Validation and/or Evaluation - Drug Product |  |  | M | M |  | M |  | M | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.3.5
 | Regulatory-Submission | Quality | Drug Product | Manufacture | General |  | Executed Production Record - Drug Product |  |  | M | M | M | M |  | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R.1.P
 | Regulatory-Submission | Quality | Drug Product | Excipients | General |  | Specifications for Excipients |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.4.1
 | Regulatory-Submission | Quality | Drug Product | Excipients | General |  | Analytical Procedures - Excipients |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.4.2
 | Regulatory-Submission | Quality | Drug Product | Excipients | General |  | Validation of Analytical Procedures - Excipients |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.4.3
 | Regulatory-Submission | Quality | Drug Product | Excipients | General |  | Justification of Specification - Excipients |  |  | M | M |  |  |  | O |  | O | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.4.4
 | Regulatory-Submission | Quality | Drug Product | Excipients | General |  | Excipients of Biological Origin |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.4.5
 | Regulatory-Submission | Quality | Drug Product | Excipients | General |  | Novel Excipients |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.4.6
 | Regulatory-Submission | Quality | Drug Product | Excipients | General |  | Novel Excipients Appendix |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.A.2
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | Specifications |  |  | M | M |  |  | O |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.5.1
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | Analytical Procedures - Drug Product |  |  | M | M |  |  | O |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.5.2
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | Assay (Recommended granularity)
 | 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 |  |  | M | M |  |  | O | O | O | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.5.3
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | Batch Analysis - Drug Product |  |  | M | M | M | M | O | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.5.4
 | 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.5.5
 | 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.5.6
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | Method Validation Package - Drug Product |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R.3
 | Regulatory-Submission | Quality | Drug Product | Controls | General |  | [NAME] |  |  | M | M | M | M | O | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.6
 | Regulatory-Submission | Quality | Drug Product | Container Closure | General |  | Container Closure - Drug Product |  |  | M | M |  |  |  |  | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.7
 | Regulatory-Submission | Quality | Drug Product | Stability | General |  | Drug Product Stability Summary and Conclusions |  |  | M | M | M | M | O | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.8.1
 | Regulatory-Submission | Quality | Drug Product | Stability | General |  | Postapproval Stability Protocol and Stability Commitment - Drug Product |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.8.2
 | Regulatory-Submission | Quality | Drug Product | Stability | General |  | Drug Product Stability Data |  |  | M | M | M | M | O | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.P.8.3
 | Regulatory-Submission | Quality | Drug Product | Stability | General |  | Primary Stability Data (Optional granularity)
 | 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 |  |  | M | M |  | M |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R.2
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Product | General |  | Description and Composition of the Drug Product - Summary |  |  | M | M | M | M |  |  | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.P.1
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Product | General |  | Pharmaceutical Development - Summary |  |  | M | M | M | M |  | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.P.2
 | 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.3
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Product | General |  | Excipients - Summary |  |  | M | M | M |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.P.4
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Product | General |  | Control of Drug Product - 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 Reference Standard(s) - 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 Container Closure System - Summary |  |  | M | M |  |  |  |  | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.P.7
 | Regulatory-Submission | Quality | Quality Overall Summary | Drug Product | General |  | Drug Product Stability - Summary |  |  | M | M | M | M |  | M | M | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.P.8
 | Regulatory-Submission | Quality | Drug Substance | Facilities and Equipment | USA |  | Facility A (recommended granularity) |  |  | M | M |  | M |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.A.1
 | 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 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.A.1
 | Regulatory-Submission | Quality | Adventitious Agents | Safety Evaluation | USA |  | TSE/BSE Documentation (Optional granularity) |  |  | M | M |  |  |  |  |  | M | M | M | M |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.A.2
 | 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 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 2.3.A.2
 | Regulatory-Submission | Quality | Drug Product | Regional | EU |  | Process Validation Scheme (EU) |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 3.2.R
 | 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
 | 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 | Quality Information | Environmental Analysis | USA |  | Environmental Analysis
 |  |  |  |  |  |  |  |  | Domain Specific - Columns apply to '[NAME]' column |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Product Name | NOTE: At least one required |  |  |  |  | Content Management |  |  |  |  |  |  |  | Document Management
 | Process Zone | Domain | Group | Sub-Group | Sub-Group |  | Artifact Name |  | 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 | Non-Clinical Study Reports | Non-Clinical Study Reports | General |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Pharmacology | General |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.1
 | Regulatory-Submission | Non-Clinical | Pharmacology Study Reports | Primary Pharmacodynamics | General |  | 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 |  | 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 | Primary Pharmacodynamics | General |  | 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 |  | 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 |  | Key Personnel List (supervisory personnel involved w/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 |  | Audit certifications and 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 |  | 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 |  | 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 |  | Individual 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 | Secondary Pharmacodynamics | 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 | Safety Pharmacology | 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 | Pharmacology Study Reports | Pharmacodynamic Drug Interactions | 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 | Pharmacokinetics | 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 | Analytical Methods and Validation Reports | 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 | Absorption | 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 | Distribution | 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 | Metabolism | 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 | Excretion | 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 | Pharmacokinetic Drug Interactions | 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 | Pharmacokinetics Study Reports | Other Pharmacokinetic Studies | 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 | Toxicology | 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 | Single 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 | Repeat dose toxicity | 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 |  |  |  |  | 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 vitro |  |  | 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 | Genotoxicity | General |  | In vivo |  |  | 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 |  |  |  |  | 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 |  | Long 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 |  | Short or medium term 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 | Carcinogenicity | General |  | Other studies |  |  | 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 |  | Reproductive and developmental toxicity |  |  | 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 |  | Fertility and early embryonic 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 |  | Embryofetal development |  |  | 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 |  | Prenatal and postnatal development, including maternal fucntionality |  |  | 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 | 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 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 4.2.3.5.4 |  |  |  |  | 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 | Local tolerance | General |  |  |  |  | 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 | Other toxicity studies | General |  | Other toxicity studies |  |  | 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 | Antigenicity | General |  | Antigenicity |  |  | 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 | Immunotoxicity | General |  | Immunotoxicity |  |  | 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 | Mechanistic studies | General |  | Mechanistic studies |  |  | 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 | Dependence | General |  | Dependence |  |  | 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 | [NAME] | General |  | [NAME] |  |  | 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 | Impurities | General |  | Impurities |  |  | 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 | Toxicology Study Reports | Other | General |  | Other |  |  | 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 | Literature References | Literature References | 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 | Summary documents | General
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Nonclinical Overview |  |  | 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 |  | Nonclinical Summary |  |  | 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 |  | Introduction |  |  | 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 Written Summary |  |  | 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 |  | Pharmacology Tabulated Summaries |  |  | 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 Written Summary |  |  | 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 |  | Pharmacokinetics Tabulated Summaries |  |  | 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 Written Summary |  |  | 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 Tabulated Summaries |  |  | 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 |  | Toxicology Overview |  |  | 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 |  | Toxicokinetics Studies & Data |  |  | 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 |  | Toxicology Drug Substance |  |  | 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 |  | Single-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 |  | Repeat-Dose Toxicity |  |  | 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 |  | Genotoxicity |  |  | 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 |  | Carcinogenicity |  |  | 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 |  | Reproductive and Developmental Toxicity |  |  | 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 |  | Local Tolerance |  |  | 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
 | Regulatory-Submission | Non-Clinical | Summary documents | Non-clinical Summaries | General |  | Other Toxicity Studies |  |  | 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
 |  |  |  |  |  |  |  |  | Domain Specific - Columns apply to '[NAME]' column |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Product Name | NOTE: At least one required |  |  |  |  | Content Management |  |  |  |  |  |  |  | Document Management
 | Process Zone | Domain | Group | Sub-Group | Sub-Group |  | Artifact Name |  | 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 |  |  |  |  | Information relating to Clinical Trials |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | [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 | Overview | General |  | Clinical Overview |  |  | 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 |  |  |  |  |  |  |  |  | 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 | M | M | M | M | 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 |  |  | ?
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Data management plan |  |  | M | 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 |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | General |  | Publication |  |  | 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 | M | M
 | Regulatory-Submission | Clinical | Clinical Study Reports | Datasets | USA |  | Data tabulation dataset |  |  | 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
 | Regulatory-Submission | Clinical | Clinical Study Reports | Datasets | USA |  | Analysis datasets |  |  | M | M | M | M | M | M | M |  |  | M
 | 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
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | USA |  | Image files |  |  | M | M | M | M | M | M | M |  |  | M
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | USA |  | Subject profiles |  |  | M | M | 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
 | Regulatory-Submission | Clinical | Clinical Study Reports |  | USA |  | Individual subject data listing |  |  | M | M | M | M | M | M | M |  |  | M