Standard Operating Procedure for Review of Agency Requests for Clarification
| Department | Regulatory Affairs |
| SOP No. | RA/2026/738 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 15/04/2026 |
| Effective Date | 15/04/2026 |
| Review Date | 15/04/2028 |
Purpose
This SOP establishes a standardized process for the review, assessment, and response preparation to requests for clarification received from regulatory agencies during the review of submissions. The objective is to ensure timely, accurate, and compliant handling of agency queries, supporting regulatory compliance, product approval processes, and maintaining good regulatory relationships.
Scope
This procedure applies to all regulatory affairs personnel involved in managing, reviewing, and responding to agency requests including but not limited to health authority queries, deficiency letters, and requests for additional information. It encompasses all product types, dosage forms, submission dossiers, and related documentation under regulatory oversight within the organization. This SOP excludes internal communications unrelated to agency interactions.
Responsibilities
- Regulatory Affairs Executives: Receive, log, and perform initial assessment of agency requests.
- Technical Specialists/Subject Matter Experts: Provide detailed responses based on expertise and data.
- Quality Assurance: Review final responses to ensure compliance with internal standards and regulatory expectations.
- Regulatory Affairs Manager: Coordinate the review workflow and approve final response submissions.
- Document Control: Ensure proper documentation, version control, and record retention of all communications.
Accountability
The Regulatory Affairs Head is accountable for overall implementation, compliance, periodic review, escalation of unresolved issues, and effectiveness assessment of this SOP within the organization.
Procedure
1. Receipt and Logging: Upon receipt of an agency request for clarification or deficiency letter via email, courier, or regulatory portal, the Regulatory Affairs Executive shall promptly log the communication in the agency query tracking system with date/time, reference number, and details.
2. Initial Review: The Regulatory Affairs team conducts an initial assessment of the query content to categorize by priority, complexity, and required expertise. Relevant departments or technical specialists are notified accordingly.
3. Preparation for Response: Assemble all relevant data, documents, and previous submission information as supporting evidence. Subject Matter Experts (SMEs) review technical queries and draft responses in compliance with applicable regulations.
4. Quality Review: Draft responses undergo quality assurance review for scientific accuracy, regulatory grammar, formatting, completeness, and adherence to internal SOPs and agency guidelines.
5. Approval: The Regulatory Affairs Manager reviews and approves the final response package for submission, ensuring all comments and concerns have been addressed satisfactorily.
6. Submission: Submit the response by the specified agency channel (e.g., regulatory portal, official email) within the stipulated timeframe. Confirm successful delivery and update the tracking system.
7. Documentation and Record Keeping: Retain all records including agency letters, internal reviews, approval documents, response submissions, and correspondence logs in dedicated regulatory files per document control requirements and GMP standards.
8. Follow-up and Monitoring: Monitor for any further agency feedback or requests. Track deadlines and escalate delays or unresolved issues to the Regulatory Affairs Head.
9. Handling Deviations or Extensions: If delays or unexpected deviations occur, document reasons, seek management approval for deadline extensions, and communicate proactively with the agency.
10. Training: Ensure all involved personnel are periodically trained on updates to this SOP, relevant regulatory requirements, and good documentation practices.
This procedure ensures consistency, compliance, and transparency during regulatory interactions, thereby mitigating risk of approval delays and supporting continuous improvement in submission management.
Abbreviations
- GMP: Good Manufacturing Practices
- QA: Quality Assurance
- RA: Regulatory Affairs
- SME: Subject Matter Expert
- SOP: Standard Operating Procedure
Documents
- Agency Query Log Template (Annexure-1)
- Agency Response Draft Template (Annexure-2)
- Response Submission Checklist (Annexure-3)
References
- ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- EU Guidelines on Good Pharmacovigilance Practices (GVP)
- FDA Guidance for Industry: Responding to Deficiency Letters
- ICH Q9: Quality Risk Management
- Internal Document Control and Record Retention Policies
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Agency Query Log Template
Purpose: To systematically record and track all agency requests for clarification and related correspondence.
| Field | Description | Example Data |
|---|---|---|
| Log ID | Unique identifier for the query | AGQ-000123 |
| Date of Receipt | Date agency query was received | 01/04/2026 |
| Agency Name | Name of health authority | European Medicines Agency |
| Reference Number | Agency’s query reference | EMA/CLR/2026/0456 |
| Submission/Dossier Identifier | Product or dossier number | PROD-XY12345 |
| Query Summary | Brief description of the query content | Request for additional stability data |
| Assigned To | Responsible team or person | Regulatory Affairs Team |
| Due Date for Response | Deadline for submission to agency | 15/04/2026 |
| Status | Current status (Open/Closed/In Progress) | Open |
| Remarks | Additional notes | Follow up email sent 05/04/2026 |
Annexure-2: Agency Response Draft Template
Purpose: To standardize preparation of responses to agency requests ensuring clarity, completeness, and compliance.
| Field | Description | Example Data |
|---|---|---|
| Response ID | Unique response document number | RESP-000789 |
| Query Reference | Agency query reference linked to response | EMA/CLR/2026/0456 |
| Date Prepared | Date the response draft was prepared | 10/04/2026 |
| Prepared By | Department preparing response | Regulatory Affairs |
| Summary of Query | Brief recap of the agency question | Request for additional stability data covering 12 months at accelerated conditions |
| Detailed Response | Comprehensive reply with references to supporting data | Attached stability report B-2026-14 including month-wise data, analytical method validations confirm compliance with ICH Q1A guidelines. |
| References | Documents cited in response | Stability Report B-2026-14, Analytical Method Validation Report AMV-2025-09 |
| Reviewer Comments | QA/Manager remarks | Validated for technical accuracy and regulatory compliance |
| Approval Status | Pending/Approved | Approved |
Annexure-3: Response Submission Checklist
Purpose: To ensure all necessary steps and documents are completed prior to submission of responses to regulatory agencies.
| Checklist Item | Status | Remarks |
|---|---|---|
| Agency query logged in tracking system | Yes | Logged as AGQ-000123 |
| Response draft prepared and reviewed | Yes | Reviewed by QA on 12/04/2026 |
| All supporting documents attached | Yes | Stability reports and method validations included |
| Regulatory Affairs Manager approval obtained | Yes | Approved on 13/04/2026 |
| Submission made via agency portal | Yes | Submitted on 14/04/2026, confirmation received |
| Records archived per Document Control | Yes | Document ID DOC-2026-0557 |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 15/04/2026 | 1.0 | Initial issue | New SOP creation |