ABSTRACT

This article provides the pharmaceutical regulatory guidelines in the European Union. This document provides the European Regulatory Authorities, European Union legislative tools, clinical trials guidelines, marketing authorization, the regulatory strategy of filing applications, mutual recognition procedure in the European Union, regulating instruments for early access to drugs, patents, data exclusivity, and data protection are all aspects of EMA pharmacovigilance and risk management. Keywords: EU-European Union, European Drug Agency, Clinical Trials, Pharmacovigilance
Publication date: 01/07/2023

https://ijbpas.com/pdf/2023/July/MS_IJBPAS_2023_7232.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.7.7232