Abstract

STUDY ON REGULATORY REQUIREMENTS OF SAFETY REPORT IN US, EUROPE, JAPAN AND INDIA

Dr. Dilip G. Maheshwari* and Ramprakash G. Parmar

Abstract

It is essential to evaluate the safety profile of pharmaceutical products during drug development and after marketing authorization. That‘s why regulatory agencies implement new rules to submit safety reports. Safety report provides concise information on safety profile of drug. In pharmaceutical industry there are two type of safety report expedited safety report and aggregated safety repots. US, Europe, Japan and India required both type safety reports. US required safety report submission through electronic format by use of FAERs and VAERs reporting system. EMA required electronic report by use of Eudravigilance system. Japan requires safety report by use adverse event reporting system and data store in PMDA data base. India requires electronic report submitted by Pharmacovigilance programme of India. US, Europe and Japan required both type safety reports as per ICH harmonized safety report format. India required harmonized ICH format only for Post Marketing Aggregated Safety Report.

Keywords: Safety, Expedited, Aggregated, Adverse.