ABSTRACT

The existing limitations of regulatory affairs make it clear that various nations must adhere to various regulatory standards in order to approve marketing authorization Applications (MAA) for novel drugs. According to the US Food and Drugs Administration (UDFDA), the European MedicalAgency (EMA), the Central Drug Standard Control Organization (CDSCO), and Health Canada, the study in this effort represents the medication approval procedure and regulatory standards. In the United States, FDA is the regulatory agency responsible for drug approval. The process typically involves multiple phases of clinical trials, rigorous data collection, and analysis to demonstrate the safety and effectiveness of the drug. The FDA may approve the drug for marketing and sale if it judges the advantages outweigh the hazards. In Europe, EMA is the central regulatory authority responsible for drug approval. The EMA follows a similar process to the FDA, but the approval is granted through a centralized procedure that allows for marketing authorization across multiple European Union (EU) member states. Health Canada is the regulatory body in charge of approving drugs in Canada. The process involves a thorough review of the drug's safety, efficacy, and quality data, and may also require additional studies or information before approval is granted. In India, the CDSCO is the regulatory agency responsible for drug approval. The process involves multiple stages of scrutiny, including pre-clinical and clinical trials, to ensure the safety and efficacy of the drug. Despite some similarities, the drug approval processes in these regions also have differencesin timelines, requirements, and documentation. Keywords: Marketing Authorization Application (MAA), NDA, Clinical Trials, Drug Approval, Clinical Trail
Publication date: 01/09/2024

https://ijbpas.com/pdf/2024/September/MS_IJBPAS_2024_8300.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.9.8300