Standard Operating Procedure for Global Registration Status Reporting
| Department | Regulatory Affairs |
| SOP No. | RA/2026/663 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 10/04/2026 |
| Effective Date | 10/04/2026 |
| Review Date | 10/04/2028 |
Purpose
This SOP establishes a standardized process for capturing, maintaining, and reporting the current global registration status of pharmaceutical products and related submissions. It aims to ensure timely, accurate, and complete tracking of regulatory registration activities across markets to support compliance, strategic planning, and audit readiness within the organization.
Scope
This procedure applies to all global product registration activities managed by the Regulatory Affairs department, including documentation and status updates related to market authorizations, dossier submissions, renewal applications, variations, and withdrawals. It encompasses all pharmaceutical dosage forms and product categories intended for international markets. The SOP excludes regulatory activities managed outside the Regulatory Affairs function or unrelated to market registrations.
Responsibilities
The following functional roles are involved in executing and supporting this SOP:
- Regulatory Affairs Associates – Collect, update, and maintain registration data and support status reporting.
- Regulatory Affairs Managers – Review, validate, and approve registration status reports.
- Quality Assurance – Monitor compliance to this SOP and conduct periodic audits.
- Data Management Team – Maintain and secure the registration status database.
- Regulatory Affairs Head – Facilitate interdepartmental coordination for information accuracy.
Accountability
The Regulatory Affairs Head holds ultimate accountability for the implementation, compliance, and periodic review of this SOP, ensuring escalation of issues, verification of data integrity, and continuous improvement of the global registration status reporting process.
Procedure
1. Preparation and Prerequisites: Ensure access to the global registration tracking system and related regulatory databases. Confirm receipt of all relevant submission acknowledgments, renewal notices, and market authorization documents prior to data entry.
2. Data Collection: Regulatory Affairs Associates shall compile all current registration records, including dossiers, submission dates, approval letters, and expiry/renewal dates from internal and external sources.
3. Status Verification and Update: Validate the accuracy of registration data against original documents and regulatory authority communications. Update the global registration tracking system with current status, including pending, approved, suspended, or withdrawn registrations.
4. In-Process Controls and Monitoring: Implement periodic checks at defined intervals (e.g., monthly/quarterly) to confirm status accuracy and identify approaching expiry or renewal dates to trigger timely follow-up actions.
5. Report Preparation: Generate registration status reports summarizing updates by region, product, and registration category. Ensure reports highlight critical compliance deadlines and discrepancies requiring management attention.
6. Review and Approval: Submit reports to Regulatory Affairs Managers and Head for review and approval prior to distribution. Address any comments or corrections promptly.
7. Distribution and Documentation: Distribute approved reports to relevant stakeholders including Regulatory Operations, Quality Assurance, and Senior Management. Archive all reports and source documents electronically with controlled access.
8. Deviation Handling: Document any deviations or inconsistencies identified during status verification. Initiate corrective actions and CAPA as per Quality System requirements.
9. Record Retention: Maintain registration data records, status reports, and associated correspondence for a minimum of five years or as mandated by applicable regulatory guidelines.
10. Periodic Review and Continuous Improvement: Conduct SOP effectiveness assessments during routine regulatory audits or biannual management reviews. Implement improvements based on feedback, audit findings, and regulatory changes.
Abbreviations
RA – Regulatory Affairs
CAPA – Corrective and Preventive Action
SOP – Standard Operating Procedure
GMP – Good Manufacturing Practice
QA – Quality Assurance
MR – Market Registration
Documents
The following documents are required for proper execution of this SOP:
- Global Registration Status Tracking Log (Annexure-1)
- Registration Status Summary Report Template (Annexure-2)
- Deviation and CAPA Report Form (Annexure-3)
References
World Health Organization (WHO) Guidelines for Registration of Pharmaceutical Products;
ICH Q10 – Pharmaceutical Quality System;
21 CFR Part 314 – Applications for FDA Approval to Market a New Drug;
EU Directive 2001/83/EC – Community Code relating to Medicinal Products for Human Use;
Internal Quality Management System Policies and Procedures.
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Global Registration Status Tracking Log
Purpose: To systematically record and monitor the registration status of pharmaceutical products across different markets.
| Product Name | Dosage Form | Country/Region | Registration Number | Submission Date | Approval Date | Status | Renewal Date | Comments |
|---|---|---|---|---|---|---|---|---|
| Paracetamol Tablets | Tablet | EU | EU-REG-2024-001 | 15/01/2024 | 22/03/2024 | Approved | 22/03/2027 | Renewal due in 3 years |
| Ibuprofen Suspension | Oral Suspension | USA | FDA-2024-IBU-056 | 10/02/2024 | – | Under Review | – | Expected response by 15/06/2026 |
| Amoxicillin Capsules | Capsule | Canada | CAN-REG-2023-152 | 05/12/2023 | 30/01/2024 | Approved | 30/01/2027 | Stable status |
Annexure-2: Registration Status Summary Report Template
Purpose: To summarize the global registration status updates for management review and stakeholder communication.
| Report Period | 01/01/2026 – 31/03/2026 |
|---|---|
| Prepared By | |
| Date | 05/04/2026 |
| Product | Region | Status | Key Updates | Next Actions |
|---|---|---|---|---|
| Paracetamol Tablets | EU | Approved | Renewal application submitted | Monitor renewal review |
| Ibuprofen Suspension | USA | Under Review | FDA query response pending | Follow up with FDA |
| Amoxicillin Capsules | Canada | Approved | No changes reported | Schedule next renewal |
Annexure-3: Deviation and CAPA Report Form
Purpose: To document any deviations identified in registration status reporting and track corrective and preventive actions.
| Deviation No. | DEV-2026-015 |
|---|---|
| Date Detected | 25/03/2026 |
| Reported By | |
| Description of Deviation | Delay in updating registration status for Ibuprofen Suspension in USA region. |
| Root Cause Analysis | Miscommunication between submission team and tracking database management. |
| Corrective Action Taken | Immediate update of registration status and confirmation of database entry. |
| Preventive Action Proposed | Implement monthly coordination meetings between teams for status updates. |
| Action Completion Date | 05/04/2026 |
| Verified By | |
| Reviewed By | |
| Approval Date | 07/04/2026 |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 10/04/2026 | 1.0 | Initial issue | New SOP creation |