Standard Operating Procedure for Tracking Product Registrations Across Global Markets
| Department | Regulatory Affairs |
| SOP No. | RA/2026/654 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 10/04/2026 |
| Effective Date | 10/04/2026 |
| Review Date | 10/04/2028 |
Purpose
This Standard Operating Procedure (SOP) defines a systematic and controlled approach for tracking product registrations across global markets to ensure compliance with local regulatory requirements, timely updates of registration status, and effective management of submission deadlines. It supports the control objective of maintaining accurate and up-to-date registration records, facilitating regulatory compliance, and minimizing risks related to market entry delays or non-compliance.
Scope
This SOP applies to all product registration and market entry activities managed by the Regulatory Affairs department involving any pharmaceutical product intended for global markets. It covers the tracking of submissions, authorizations, renewals, maintenance, and variations related to all product dosage forms and categories. Excluded are registrations related to clinical trials or investigational submissions beyond market authorization scope.
Responsibilities
- Regulatory Affairs Specialists – Execute data entry, monitoring of registration statuses, and updates to tracking systems.
- Regulatory Affairs Managers – Review tracking records for completeness and accuracy, approve significant status updates.
- Compliance Officers – Supervise adherence to timelines and regulatory commitments.
- Quality Assurance – Verify procedural compliance during internal or external audits.
- Document Control – Ensure controlled access and versioning of registration tracking documentation.
Accountability
The Regulatory Affairs Head is accountable for the effective implementation, compliance monitoring, periodic review, escalation of issues, and ensuring the overall effectiveness of this SOP. This role also ensures that training is provided and that records are properly maintained and accessible.
Procedure
The following procedure outlines the standardized process for tracking product registrations across global markets:
1. Preparation and Prerequisites: Ensure access to all regulatory databases, internal registration tracking systems, and relevant country-specific regulatory guidances. Confirm that responsible personnel have received appropriate training on this SOP and tools used.
2. Initial Data Collection: Upon product submission for registration, collect all relevant information including application numbers, dossier versions, submission dates, and country-specific regulatory references. Enter these details into the centralized tracking system promptly.
3. Monitoring and Updating: Continuously monitor the status of each registration from submission through approval, renewal, variation, or rejection. This involves regular checks of regulatory authority portals, correspondence, and internal communications. Update the tracking system with current status, action items, and deadlines.
4. In-Process Controls: Implement periodic cross-checks by Regulatory Affairs Managers to verify data accuracy and assess compliance with submission timelines and renewal cycles. Address discrepancies or deviations with corrective actions documented in the tracking records.
5. Verification and Acceptance Criteria: Confirm that all required registration milestones are met within stipulated deadlines. Acceptance criteria include completeness of registration dossier data, clear status updates, and documented follow-up actions for pending items.
6. Managing Deviations and Escalations: Identify and document any deviations from planned registration timelines or unexpected regulatory feedback. Escalate issues to the Regulatory Affairs Head or Compliance Officer as needed for resolution. Record investigation outcomes and corrective measures.
7. Approvals and Documentation: Significant changes in registration status such as final approvals, rejections, or major variations must be reviewed and approved by the Regulatory Affairs Manager. All registration tracking entries must be documented with dates, responsible personnel initials, and version-controlled records.
8. Record Retention: Maintain all registration tracking records, correspondence, and regulatory documents in compliance with organizational record retention policies and regulatory expectations for audit readiness.
9. Closure and Review: Annually review all active registrations to update status and validate the ongoing compliance of the registrations. Archive closed or expired registrations according to retention policies.
This procedural framework ensures a comprehensive, real-time, and controlled approach to managing global product registrations aligned with GMP and regulatory requirements.
Abbreviations
- GMP: Good Manufacturing Practices
- SOP: Standard Operating Procedure
- RA: Regulatory Affairs
- QA: Quality Assurance
- ICT: Information and Communication Technology
- CAPA: Corrective and Preventive Action
Documents
Essential documents for this SOP include:
- Global Product Registration Tracking Log (Annexure-1)
- Registration Status Update Form (Annexure-2)
- Deviation and Escalation Report Form (Annexure-3)
References
- ICH Q7: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
- EU Regulation 2017/745 on Medical Devices (for applicable products)
- FDA Guidance for Industry: Product Registration and Listing
- Internal Document Control Policy
- Internal Training Records for SOP compliance
Version
1.0
Approval
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| Checked By | |
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Annexures
Annexure-1: Global Product Registration Tracking Log
Purpose: To systematically document all relevant information pertaining to product registrations across various global markets ensuring effective tracking and management.
| Product Name | Market/Country | Registration Number | Submission Date | Approval Date | Current Status | Next Renewal Date | Responsible Person |
|---|---|---|---|---|---|---|---|
| Product A | Germany | DE-REG-2026-001 | 15/01/2026 | 05/03/2026 | Approved | 05/03/2028 | Regulatory Specialist 1 |
| Product B | Brazil | BR-REG-2026-045 | 28/02/2026 | Pending | – | – | Regulatory Specialist 2 |
| Product C | Japan | JP-REG-2026-010 | 01/03/2026 | – | Under Review | – | Regulatory Specialist 3 |
Annexure-2: Registration Status Update Form
Purpose: To formally record any changes or updates to registration statuses with necessary approvals and supporting information.
| Product Name: | Product B |
| Market/Country: | Brazil |
| Registration Number: | BR-REG-2026-045 |
| Date of Update: | 10/04/2026 |
| Previous Status: | Pending |
| Updated Status: | Under Review |
| Comments: | Additional documentation requested by authority, submitted on 09/04/2026. |
| Updated By (Initials): | RS2 |
| Reviewed By: | Regulatory Affairs Manager |
| Approval Signature: | ______________________ |
| Date: | 10/04/2026 |
Annexure-3: Deviation and Escalation Report Form
Purpose: To document any deviations or issues arising during registration tracking and outline corrective actions and escalation steps taken.
| Deviation/Escalation ID: | DEV-REG-0426-001 |
| Product Name: | Product C |
| Market/Country: | Japan |
| Date Identified: | 02/04/2026 |
| Description of Deviation: | Delay in document submission beyond agreed timeline. |
| Root Cause: | Internal document review delays. |
| Corrective Action Taken: | Expedited internal review and prioritized submission. |
| Escalated To: | Regulatory Affairs Head |
| Escalation Date: | 03/04/2026 |
| Resolved Date: | 08/04/2026 |
| Reported By: | RS3 |
| Approved By: | ______________________ |
| Date: | 10/04/2026 |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 10/04/2026 | 1.0 | Initial issue | New SOP creation |