Good Pharmacovigilance Practice Guide

Medicines and Healthcare products Regulatory Agency (MHRA)

Commercial pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to identifying new information about hazards associated with medicines and preventing harm to patients. Pharmacovigilance is particularly concerned with adverse drug reactions. This text complements current legislation and guidance and provides practical advice about achieving an appropriate system of pharmacovigilance.

This guide was primarily developed for UK Marketing Authorisation Holders (MAHs). It will also be of great interest to pharmacovigilance consultants. The use of third-party service providers for pharmacovigilance activities is quite common, particularly for smaller organisations which do not have in-house pharmacovigilance expertise. The guide references European legislation and guidance and so should be applicable across Europe.

The MHRA has identified a need for writing and publishing a guide to Good Pharmacovigilance Practice.

Contents:

1. EEA Qualified Person Responsible for Pharmacovigilance:
2. Management of Pharmacovigilance Data:
3. Spontaneous Case Processing:
4. Literature Searching:
5. Periodic Safety Update Reports:
6. Evaluation of Safety Data:
7. Risk Management Plans:
8. Reference Safety Information:
9. Quality Management System:
10. Interactions Between Pharmacovigilance and Other Functions:
11. Contracts and Agreements:
12. Safety Reporting for Clinical Trials: Annexes.