Regulatory Requirements for Drug Approval: A Comprehensive Review

Abstract:

The drug approval process is vital for ensuring the safety, efficacy, and quality of pharmaceutical products. This review comprehensively examines the regulatory frameworks governing drug approval in the United States, the European Union, and Japan. The discussion encompasses the entire process from preclinical research to post-marketing surveillance, with an emphasis on key requirements at each stage. In the United States, the process begins with preclinical research and progresses through Investigational New Drug (IND) applications, clinical trials, New Drug Applications (NDA), and post-marketing surveillance. Similarly, the European Union follows a structured path involving Clinical Trial Applications (CTA), clinical trials, Marketing Authorization Applications (MAA), and post-marketing requirements. Japan's process includes Clinical Trial Notifications (CTN), clinical trials, New Drug Applications (NDA), and post-marketing surveillance. Additionally, this review highlights harmonization efforts by international bodies such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to streamline and standardize drug approval procedures across different regions. These harmonization efforts aim to provide a cohesive regulatory landscape, facilitating the development and approval of new pharmaceutical products globally. The review aims to provide a detailed understanding of the regulatory, essential for stakeholders in the pharmaceutical industry. Keywords: Drug approval, FDA, Clinical trials, NDA, IND.

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