Inside PRAC (Sept 2025): What EMA’s Safety Experts Decided, and What That Means for You
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) met from 1-4 September 2025. Their role: monitor the safety of medicines in the EU, assess risk signals, recommend actions, and ensure the benefit/risk of drugs remains favorable. Here are the key takeaways from the meeting, plus deeper insight into why they matter. Key Decisions & […]
Periodic Safety Update Report for Pharmacovigilance and safety monitoring
The Indian guidance regarding pharmacovigilance system has given description about the preperation and submission of periodic safety update reports. Introduction: The Periodic Safety Update Report is a document for evaluation of the benefit-risk profile of a pharmaceutical product submitted by the MAH at defined time points as per Drugs and Cosmetics Act, 1940 and Rules thereunder during […]