Abstract

COMPARATIVE ANALYSIS OF PHARMACOVIGILANCE REGULATION IN EUROPE AND MALAYSIA

Nikhil R Mervana*, Ms.Krupa C Thula, Dr.Dilip Maheshwari

ABSTRACT

Pharmacovigilance is science and activities relating to the detection, evaluation, understanding, and prevention of adverse reactions to medicines or any other medicine-related problems.Regulatory requirements for Pharmacovigilance in different countries are varying from each other so it is challenging for companies to develop and making pharmacovigilance requirement and comply with the requirement of different countries. The objective of this work to compared the regulatory requirement of pharmacovigilance in Europe and Malaysia. It also helps to understand the regulatory requirement in relation to pharmacovigilance in regulated (Europe) and semi regulated country (Malaysia). This article mainly focuses on pharmacovigilance guideline related to adverse drug reaction (ADR),Periodic Safety Update Report (PSUR); and Risk Management system in Europe and Malaysia.

Keywords: Pharmacovigilance, ADR, PSUR, Risk Management Plan (RMP)