A NEW ERA OF DRUG SAFETY â€“ NEW EU PHARMACOVIGILANCE (PV) LEGISLATION AND COMPARISON OF PV IN EU, US AND INDIA
A series of public health disasters (Thalidomide in the 1960s to Rofecoxib (Vioxx) at the beginning of this century have served to remind us that effective Pharmacovigilance (PV) is crucial for protection of citizens. The introduction of new PV legislation in July 2012 is the biggest change to the regulation of human medicines in the European Union (EU) since 1995. New requirements and procedures for Post-Authorization Safety Studies (PASS) open the gateway for development of real-world effectiveness outcomes. Similarly, the United States Food and Drug Administration (USFDA) has become more open to inclusion of non-safety data collection in its safety surveillance mandates and more proactive risk management approach. In addition, the Marketing Authorisation Holders (MAHs) need to be more efficient with their post-authorisation activities to maximize their utility. The main goal of this new PV path is to strengthen the public health. However it is also concerned with improved efficiency, clear decision-making processes, reduce duplication and better use of Information Technology in PV process.Keywords: Pharmacovigilance, European Medicine Agency, Good Pharmacovigilance practice, New EU PV Legislation, Food and Drug Administration, Signal detection, Risk Management Plan.
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