Guidelines for Pharmacovigilance Annual Safety Reports (ASR)

1) Purpose

The purpose of this SOP is to provide guidelines for the preparation, submission, and review of Annual Safety Reports (ASRs) in pharmacovigilance.

2) Scope

This SOP applies to pharmacovigilance personnel responsible for the preparation, review, and submission of ASRs within the organization.

3) Responsibilities

The Pharmacovigilance (PV) Manager is responsible for overseeing ASR preparation and submission. PV staff involved in ASR activities are responsible for adhering to this SOP.

4) Procedure

4.1 ASR Preparation

1. Identify medicinal products requiring ASR submission based on regulatory requirements and product lifecycle stage.
2. Collect and compile pharmacovigilance data, including adverse event reports, safety updates, and risk assessments, for inclusion in the ASR.

4.2 ASR Content

1. Outline the structure and content requirements for ASRs, including sections on product overview, safety data summary, signal detection, and risk evaluation.
2. Ensure that ASRs comply with regional regulatory requirements, such as those outlined in ICH guidelines and local pharmacovigilance regulations.

4.3 ASR Review

1. Conduct internal review and quality assurance checks to ensure accuracy, completeness, and consistency of ASR content.
2. Seek input and approval from relevant stakeholders, including medical experts, regulatory affairs, and quality assurance teams.

4.4 ASR Submission

1. Prepare ASRs for submission to regulatory authorities within specified timelines and according to regional requirements.
2. Document ASR submission processes, including tracking and confirmation of receipt by regulatory agencies.

4.5 ASR Follow-up

1. Respond promptly to requests for additional information or clarification from regulatory authorities regarding submitted ASRs.
2. Monitor regulatory updates and requirements related to ASR submission and incorporate changes into future ASR preparations.

4.6 Documentation and Record Keeping

1. Maintain comprehensive records of ASR preparation, review, submission, and correspondence with regulatory agencies.
2. Ensure that all ASR documentation is stored securely and is accessible for regulatory inspections and audits.

4.7 Training and Education

1. Provide training to PV staff on ASR requirements, preparation processes, and regulatory expectations.
2. Ensure that PV team members are knowledgeable about pharmacovigilance guidelines and best practices related to ASR preparation and submission.

4.8 Continuous Improvement

1. Regularly review ASR procedures and templates based on feedback, regulatory changes, and inspection findings.
2. Implement improvements to streamline ASR preparation, enhance data quality, and ensure compliance with evolving regulatory requirements.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, ASR – Annual Safety Report

6) Documents, if any

ASR templates, pharmacovigilance data summaries, regulatory guidelines, training materials.

7) Reference, if any

ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Pharmacovigilance Responsibilities of Marketing Authorization Holders (MAHs), EU Guidelines on Good Pharmacovigilance Practices (GVP) Module VII – Periodic Safety Update Reports (PSURs).

8) SOP Version

Version 1.0