preprints.org > medicine and pharmacology > medicine and pharmacology > doi: 10.20944/preprints202408.0031.v1 (registering DOI)

Preprint Article Version 1 This version is not peer-reviewed

Version 1 : Received: 31 July 2024 / Approved: 1 August 2024 / Online: 1 August 2024 (11:15:43 CEST)

The research article provides an in-depth analysis of the European Medicines Agency (EMA) and the Directorate General of Drug Administration (DGDA), focusing on their historical development, organizational structures, and functional roles in ensuring the quality and safety of pharmaceuticals. The study highlights the origins of drug regulation, tracing back to the early 19th century in the United States with the establishment of the Food and Drug Administration (FDA), and discusses the evolution and significance of drug regulatory bodies worldwide. The EMA and DGDA are scrutinized for their efforts in maintaining high standards for drug approval, monitoring clinical trials, and managing post-marketing surveillance to prevent adverse drug reactions (ADRs). The EMA’s role in coordinating with EU member states on pharmacovigilance and the DGDA’s initiatives in Bangladesh, including the implementation of a nationwide drug database and pharmacovigilance system, are explored in detail. The article concludes by emphasizing the essential role of these regulatory bodies in safeguarding public health through stringent regulation and continuous monitoring of pharmaceuticals, thereby ensuring that only safe and effective medicines are available to consumers . It also provides an in-depth analysis of the roles, structures, and historical contexts of the European Medicines Agency (EMA) and the Directorate General of Drug Administration (DGDA). It outlines how these regulatory bodies ensure the safety, efficacy, and quality of medicinal products. The EMA, serving the European Union, and the DGDA, operating in Bangladesh, play critical roles in drug approval processes, pharmacovigilance, and maintaining public health standards. By setting rigorous guidelines and monitoring compliance, these agencies help safeguard the health of millions, ensuring that only safe and effective medications are available in the market. The paper underscores the importance of these regulatory bodies in promoting public health and supporting the pharmaceutical industry's development and innovation.

EMA, DGDA, Drug Regulatory Authorities, Manufacturing Guidelines, Quality Medicine, Good Laboratory Practice, cGMP,GMP,GLP,IPQC,QC,QA,Quality Control, Quality Assurance, Current Good Manufacturing Practice, Good Manufacturing Practice, 

Medicine and Pharmacology, Medicine and Pharmacology

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