Role of Drug Regulatory Authorities in Ensuring Safety, Quality, And Efficacy of Medicines
DOI:
https://doi.org/10.48047/Keywords:
Drug Regulatory Authorities, Pharmaceutical Safety, Good Manufacturing Practice, Pharmacovigilance, Regulatory HarmonizationAbstract
This research comprehensively examines the critical role of drug regulatory authorities in ensuring pharmaceutical safety, quality, and efficacy throughout the medicine lifecycle. The study systematically analyzes regulatory frameworks, approval processes, manufacturing oversight, and post-market surveillance mechanisms employed by major global regulatory bodies including the FDA, EMA, and PMDA. Through extensive literature review and analysis of regulatory data from 2018-2023, this investigation reveals significant variations in approval timelines across jurisdictions, with median review times ranging from 10.2 to 15.6 months
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