Standard Operating Procedure for Handling Inquiries from Regulatory Agencies in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/050/2025 |
| Supersedes | SOP/BA-BE/050/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To establish a standardized and compliant process for receiving, evaluating, and responding to inquiries, clarification requests, and deficiency letters from regulatory agencies in relation to Bioavailability/Bioequivalence (BA/BE) studies.
2. Scope
This SOP applies to all communications and queries received from regulatory agencies including US FDA, EMA, CDSCO, WHO PQ, Health Canada, TGA, and other global health authorities concerning BA/BE study submissions or inspections.
3. Responsibilities
- Regulatory Affairs: Acts as the point of contact with regulatory agencies, coordinates internal review and prepares responses.
- Subject Matter Experts (SMEs): Provide scientific and technical input to formulate appropriate responses.
- Quality Assurance (QA): Verifies response accuracy and completeness before submission.
4. Accountability
The Head of Regulatory Affairs is accountable for ensuring that all regulatory communications are addressed accurately, within the stipulated timelines, and are documented appropriately.
5. Procedure
5.1 Receipt and Acknowledgment of Inquiry
- All incoming communications from regulatory agencies must be acknowledged within 2 business days.
- Log the inquiry in Annexure-1: Regulatory Inquiry Log, including date received, agency, subject, and responsible owner.
5.2 Internal Evaluation and Assignment
- Regulatory Affairs to initiate a review meeting with relevant stakeholders within 3 working days of receipt.
- Classify the query as:
- Administrative
- Technical/Clinical
- CMC (Chemistry, Manufacturing and Controls)
- Safety-related
- Assign responsibilities to SMEs and define timelines using Annexure-2: Query Assignment Sheet.
5.3 Drafting the Response
- SMEs prepare the initial response draft with relevant data, justifications, and references.
- Regulatory Affairs reviews and consolidates responses into a unified document as per agency format (e.g., eCTD, PDF).
5.4 Quality Review and Approval
- Submit the compiled response for QA review using Annexure-3: Response Review Checklist.
- Correct any identified gaps or inconsistencies prior to final approval.
- Obtain formal approval and signatures using Annexure-4: Regulatory Submission Approval Form.
5.5 Submission and Documentation
- Submit the final response via official regulatory portal (e.g., ESG, XEVMPD, SUGAM).
- Maintain a copy in the Trial Master File (TMF) or Regulatory Archive.
- Update Annexure-1 with submission date and closure remarks.
5.6 Follow-Up and Tracking
- Monitor agency portals/emails for confirmation of receipt or further communication.
- Log any follow-up queries in Annexure-5: Response Tracking and Resolution Log.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- SME: Subject Matter Expert
- QA: Quality Assurance
- eCTD: Electronic Common Technical Document
7. Documents
- Regulatory Inquiry Log – Annexure-1
- Query Assignment Sheet – Annexure-2
- Response Review Checklist – Annexure-3
- Regulatory Submission Approval Form – Annexure-4
- Response Tracking and Resolution Log – Annexure-5
8. References
- ICH E6(R2) – Good Clinical Practice
- US FDA Guidance on Responding to Information Requests
- EMA Procedural Advice on Dossier Review
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 Inquiry Log
| Date Received | Agency | Subject | Owner | Status |
|---|---|---|---|---|
| 12/04/2025 | US FDA | Request for dissolution data | Sunita Reddy | Closed |
Annexure-2: Query Assignment Sheet
| Query No. | Description | Assigned To | Due Date | Status |
|---|---|---|---|---|
| Q-001 | Provide comparative PK justification | Rajesh Kumar | 15/04/2025 | Submitted |
Annexure-3: Response Review Checklist
| Check Point | Status | Reviewer Comments |
|---|---|---|
| Scientific Justification Adequate | Yes | Well-documented |
Annexure-4: Regulatory Submission Approval Form
| Submission Title | Date | Approved By | Designation |
|---|---|---|---|
| ANDA IR-2025-Q2 | 16/04/2025 | Dr. Arvind Shah | Head – Regulatory Affairs |
Annexure-5: Response Tracking and Resolution Log
| Agency | Initial Response Date | Follow-up Date | Final Status | Remarks |
|---|---|---|---|---|
| EMA | 10/03/2025 | 22/03/2025 | Accepted | Query resolved with no further request |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 15/01/2022 | 1.0 | Initial version | First formal documentation | QA Head |
| 17/04/2025 | 2.0 | Incorporated annexures and multi-agency support | Enhancement for global compliance | QA Head |