Standard Operating Procedure for Regulatory Submission Planning for Bioequivalence Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/008/2025 |
| Supersedes | SOP/BA-BE/008/2022 |
| Page No. | Page 1 of 13 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define a standard process for planning and preparing regulatory submissions for Bioequivalence (BE) studies, ensuring timely and complete documentation for national and international health authority requirements.
2. Scope
This SOP applies to the Regulatory Affairs department and all cross-functional teams involved in compiling, reviewing, and submitting dossiers for BE study approvals in markets such as the US, EU, India, Canada, and WHO-recognized regions.
3. Responsibilities
- Regulatory Affairs: Leads the planning, preparation, and coordination of submission documents.
- Clinical Research: Provides study design, protocol, and investigator details.
- Medical Writer: Prepares synopsis, protocol sections, and clinical overviews.
- Quality Assurance: Reviews documents for GCP compliance and regulatory consistency.
4. Accountability
The Head of Regulatory Affairs is accountable for ensuring that all BE study submissions meet regional regulatory expectations and submission timelines.
5. Procedure
5.1 Regulatory Landscape Evaluation
- Identify the target submission country/region (e.g., USFDA, EMA, CDSCO, TGA).
- Review applicable submission guidelines:
- USFDA – ANDA Guidelines
- EMA – EU CT Regulation and BE guidance
- CDSCO – Form 44 and BA/BE approval process
- WHO – Prequalification BE requirements
- Document the specific documents required using Annexure-1: Regulatory Requirements Checklist.
5.2 Timeline and Milestone Planning
- Develop a submission Gantt chart with key milestones:
- Protocol finalization
- Ethics and regulatory submissions
- Site readiness
- Study initiation and completion
- Clinical study report (CSR) availability
- Dossier compilation and submission
- Use Annexure-2: Submission Timeline Tracker to track progress.
5.3 Dossier Content Planning
- Compile dossier as per the CTD format (Modules 1-5) or as required by national authorities.
- Ensure inclusion of:
- Clinical trial protocol
- Informed consent documents
- Clinical Investigator Brochure
- Safety and pharmacokinetic data
- Assign responsibilities for each module to relevant stakeholders.
5.4 Regulatory Query Management Plan
- Designate team for regulatory query handling (Medical, Regulatory, QA).
- Maintain query-response log (Annexure-3).
- Develop SOP-based response timelines (typically 7–14 days).
5.5 Approval Tracking and Archive
- Track submission approvals and communications using the regulatory database or tracker.
- Store approval letters, correspondence, and submission documents in the eTMF.
6. Abbreviations
- BE: Bioequivalence
- ANDA: Abbreviated New Drug Application
- CDSCO: Central Drugs Standard Control Organization
- CSR: Clinical Study Report
- CTD: Common Technical Document
- eTMF: Electronic Trial Master File
7. Documents
- Regulatory Requirements Checklist – Annexure-1
- Submission Timeline Tracker – Annexure-2
- Regulatory Query Response Log – Annexure-3
8. References
- USFDA Guidance for Industry – ANDA Submissions
- EMA Clinical Trials Regulation (EU CTR)
- ICH M4 – CTD Structure
- WHO BE Guidelines for Prequalification
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Regulatory Requirements Checklist
| Region | Key Documents | Guidance Referred |
|---|---|---|
| USFDA | Protocol, CSR, Safety Summary, Form FDA 356h | ANDA Guidance |
| EMA | CTA, IB, Risk Management Plan | EU CTR |
Annexure-2: Submission Timeline Tracker
| Milestone | Planned Date | Actual Date | Status | Responsible |
|---|---|---|---|---|
| Protocol Finalization | 20/04/2025 | – | Pending | Rajesh Kumar |
| EC Submission | 28/04/2025 | – | Scheduled | Sunita Reddy |
Annexure-3: Regulatory Query Response Log
| Date Received | Agency | Query Summary | Response Due | Status |
|---|---|---|---|---|
| 12/03/2025 | CDSCO | Clarify rationale for sample size | 19/03/2025 | Responded |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 15/01/2022 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 17/04/2025 | 2.0 | Added WHO and EMA components and revised annexures | Annual Review | QA Head |