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Abstract

The drug approval and review process plays a crucial role in the pharmaceutical industry, aiming to ensure that newly marketed drugs are safe, effective, and of high quality. Regulatory authorities overseeing this process, tailored to geographically distinct needs, include the U.S. FDA, EMA, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), China’s National Medical Products Administration (NMPA), and India’s Central Drugs Standard Control Organization (CDSCO). This analysis offers insight into the various drug approval processes employed by these authorities and examines the International Council for Harmonisation’s ongoing efforts to establish a global consensus on drug regulation standards. It also compares regulatory pathways and highlights current harmonization initiatives. The focus is on analyzing operational aspects of drug regulation and identifying challenges arising from these regulations. The ultimate goal is to present a clear understanding of the intricacies and dynamics of the global drug approval process. Regulating the drug approval process is essential to ensure that new drugs are safe for public consumption, as the introduction of a new drug often faces numerous hurdles beyond safety and efficacy. The challenges highlighted include variations in regulations between authorities, the complexity of modern therapeutics, and the balance between safety and speed. This paper provides an overview of innovations in drug development, their impact on regulatory pathways, ongoing harmonization efforts, and potential obstacles that may arise during the regulatory process.

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2025-09-04
2025-11-04

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/content/journals/cds/10.2174/0115748863392869250827042742
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Global Analysis of Regulatory Frameworks and Drug Safety Standards in the Drug Approval Process
Bentham Science Publishers ; https://doi.org/10.2174/0115748863392869250827042742
/content/journals/cds/10.2174/0115748863392869250827042742
/content/journals/cds/10.2174/0115748863392869250827042742
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  • Article Type:     Review Article
Keywords: drug approval process ; regulatory harmonization ; global regulatory authorities ; clinical trials ; efficacy ; safety ; drug development ; regulatory practices ; regulatory 
frameworks ; Biologics

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