Standard Operating Procedure for Preparation of Dossiers for US FDA ANDA Submissions
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/010/2025 |
| Supersedes | SOP/BA-BE/010/2022 |
| Page No. | Page 1 of 14 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define a standardized procedure for preparing and compiling a regulatory-compliant Abbreviated New Drug Application (ANDA) dossier in eCTD format for submission to the United States Food and Drug Administration (US FDA).
2. Scope
This SOP applies to Regulatory Affairs personnel and cross-functional teams involved in dossier preparation, including Quality, Formulation Development, Clinical, and Bioanalytical departments for US ANDA submissions.
3. Responsibilities
- Regulatory Affairs: Leads the dossier compilation and ensures alignment with US FDA requirements.
- Formulation Development: Provides pharmaceutical development reports and composition details.
- Clinical Team: Submits protocol, CSR, and bioanalytical summaries.
- Quality Assurance: Ensures data integrity, SOP compliance, and completeness of quality modules.
4. Accountability
The Director of Regulatory Affairs is accountable for the accuracy, completeness, and timely submission of the ANDA dossier to the US FDA.
5. Procedure
5.1 Identify Product and Submission Type
- Confirm the product’s reference listed drug (RLD) from the FDA Orange Book.
- Determine if the submission is a standard ANDA or an ANDA with a Paragraph IV certification.
5.2 CTD Module Planning
- Prepare the ANDA in eCTD format using the CTD structure:
- Module 1: Regional Information (Form FDA 356h, labeling, correspondence)
- Module 2: CTD Summaries (quality, nonclinical, and clinical summaries)
- Module 3: Quality (drug substance, drug product, manufacturing process)
- Module 4: Nonclinical Study Reports (if applicable)
- Module 5: Clinical Study Reports and BE data
- Refer to ICH M4 guidelines for structure and formatting.
5.3 Data Collection and Compilation
- Gather documents required for each module using Annexure-1: ANDA CTD Module Checklist.
- Ensure compatibility with the Electronic Common Technical Document (eCTD) software used for publishing.
- Collect Module 5 BE study documents:
- Protocol and amendments
- Informed consent documents
- Clinical study report
- Statistical analysis report
- Bioanalytical method validation
- Sample analysis and raw data
5.4 eCTD Publishing and Validation
- Use validated eCTD publishing software for document compilation and structure.
- Perform technical validation of the eCTD backbone before submission.
- Address validation errors before filing.
5.5 Pre-Submission Review
- Conduct internal QA review of the final ANDA package using Annexure-2: Dossier Review Checklist.
- Ensure proper referencing and cross-linking within the eCTD submission.
- Ensure that the Module 1 contains:
- Form FDA 356h
- User Fee Cover Sheet (Form FDA 3794)
- Financial certification forms (Forms FDA 3454 & 3455)
5.6 Submission to US FDA
- Submit the eCTD submission via the ESG (Electronic Submission Gateway).
- Track acknowledgment and technical acceptance from FDA gateway.
- Maintain submission tracking using Annexure-3: ANDA Submission Log.
6. Abbreviations
- ANDA: Abbreviated New Drug Application
- BE: Bioequivalence
- eCTD: Electronic Common Technical Document
- FDA: Food and Drug Administration
- ESG: Electronic Submission Gateway
- CSR: Clinical Study Report
7. Documents
- ANDA CTD Module Checklist – Annexure-1
- Dossier Review Checklist – Annexure-2
- ANDA Submission Log – Annexure-3
8. References
- USFDA Guidance – ANDA Submissions – Content and Format
- ICH M4 Guidelines – CTD Structure
- eCTD Technical Conformance Guide
- FDA Orange Book Database
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: ANDA CTD Module Checklist
| Module | Document Name | Available (Yes/No) | Remarks |
|---|---|---|---|
| Module 1 | Form FDA 356h | Yes | Signed |
| Module 5 | BE Clinical Study Report | Yes | Ready for eCTD |
Annexure-2: Dossier Review Checklist
| Item | Status | Reviewer | Date |
|---|---|---|---|
| Cross-link verification | Complete | Rajesh Kumar | 10/04/2025 |
| Summary consistency | Complete | Sunita Reddy | 11/04/2025 |
Annexure-3: ANDA Submission Log
| Submission Date | eCTD Sequence No. | FDA Acknowledgment | Status |
|---|---|---|---|
| 15/04/2025 | 0000 | Received | Under Technical Review |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial SOP Release | New Document | QA Head |
| 17/04/2025 | 2.0 | Incorporated eCTD and ESG process steps | Regulatory Updates | QA Head |