Abstract

REGULATORY OVERVIEW AND COMPARISON OF PHARMACOVIGILANCE GUIDELINES IN USFDA AND EMA

Akshatha and Chandan B. V.*

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Abstract

Pharmacovigilance guidelines and regulations are critical components of drug safety and play a key role in ensuring the safety and efficacy of drugs on the market. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are two regulatory agencies that have established guidelines and regulations for pharmacovigilance. This review article provides a comparison of the pharmacovigilance guidelines and regulations issued by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The article examines the differences and similarities between the two agencies in terms of adverse event reporting, risk management plans, signal detection and management, periodic safety update reports, and post-authorization safety studies. The article notes that both the FDA and EMA require the reporting of serious adverse events within a 15- day timeline, but the FDA has a 90-day timeline for the reporting of non-serious events while the EMA allows for up to 90 days for both serious and non-serious events. The article suggests that this difference may impact the ability to detect potential safety issues early. The article also highlights differences in requirements for periodic safety update reports (PSURs) and periodic benefitrisk evaluation reports (PBRERs). The EMA requires PSURs for all authorized medicines in the European Union, while the FDA does not require PSURs but instead requires PBRERs for some medicines. The article suggests that this difference in requirements may reflect differences in the approach to risk management between the agencies. Overall, the review article provides a concise overview and comparison of pharmacovigilance guidelines and regulations issued by the FDA and EMA. The article highlights important differences and similarities between the two agencies, which could impact the development and marketing of new drugs in both the US and Europe.

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