A COMPARATIVE STUDY OF THE DRUG REGULATORY AND MARKET AUTHORIZATION FRAMEWORK OF THE EUROPEAN UNION AND UNITED STATES
Pharmaceuticals must be regulated and approved in the European Union (EU) and the United States (US) to ensure their safety, efficacy, and quality. An analysis of key differences and similarities between these two regions' regulatory frameworks and approval processes is provided in this study. A single marketing authorization is valid in all EU member states under the centralised procedure overseen by the European Medicines Agency (EMA). Decentralized and mutual recognition procedures also allow national approvals to be recognized by other members. A New Drug Application (NDA) and Biologics License Application (BLA) are the approval processes managed by the US Food and Drug Administration (FDA). The regulatory requirements and timelines between the two regions differ, but both require rigorous preclinical and clinical testing. Drug safety and efficacy are monitored by robust pharmacovigilance systems at both the EMA and FDA after approval. Regulatory policies are also examined in the study in terms of their impact on pharmaceutical innovation and market access. Pharmaceutical companies seeking to navigate the complex processes of drug development and commercialization must understand these regulatory landscapes. The comparative analysis highlights the importance of harmonizing global regulatory standards to facilitate access to safe and effective medicines around the world
14 , 1 , 2024
14 - 17
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