Guidelines for Pharmacovigilance Regulatory Submission

1) Purpose

The purpose of this SOP is to establish procedures for the preparation, submission, and management of pharmacovigilance regulatory submissions to regulatory authorities.

2) Scope

This SOP applies to all pharmacovigilance personnel responsible for preparing and submitting regulatory documents, including pharmacovigilance managers, regulatory affairs specialists, and compliance officers.

3) Responsibilities

The Regulatory Submission Team is responsible for ensuring the accuracy, completeness, and timeliness of pharmacovigilance regulatory submissions. The Pharmacovigilance (PV) Manager oversees regulatory submission activities to ensure compliance with regulatory requirements and guidelines.

4) Procedure

4.1 Preparation of Regulatory Submissions

1. Identify regulatory submission requirements based on regional regulations (e.g., FDA, EMA, Health Canada).
2. Collect and compile pharmacovigilance data and documents required for submission, such as Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).
3. Review and verify the accuracy and completeness of submission documents.

4.2 Submission Planning and Timeline

1. Develop a submission plan outlining timelines, milestones, and responsibilities for each regulatory submission.
2. Coordinate with cross-functional teams (e.g., medical affairs, clinical operations) to gather necessary data and input for submission.
3. Ensure alignment of submission timelines with regulatory deadlines and requirements.

4.3 Submission Package Assembly

1. Prepare submission packages according to regulatory guidelines and templates.
2. Ensure documents are formatted and labeled correctly, including version control and document metadata.
3. Obtain necessary approvals from designated personnel (e.g., PV Head, Regulatory Affairs).

4.4 Submission Process

1. Submit regulatory documents electronically or through authorized submission portals (e.g., EudraVigilance, FDA Electronic Submissions).
2. Monitor submission status and confirm receipt by regulatory authorities.
3. Address any queries or requests for additional information from regulatory authorities promptly.

4.5 Post-Submission Activities

1. Track and document submission timelines, acknowledgments, and follow-up actions.
2. Archive submission documents and correspondence for audit and inspection purposes.
3. Conduct post-submission reviews to identify areas for improvement in future submissions.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, ICSR – Individual Case Safety Report, PSUR – Periodic Safety Update Report, RMP – Risk Management Plan

6) Documents, if any

Submission templates, submission logs, approval records, correspondence with regulatory authorities.

7) Reference, if any

EU Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products, FDA Guidance for Industry – Providing Regulatory Submissions in Electronic Format.

8) SOP Version

Version 1.0