• Kumar Aditya
• Raushan Kumar Singh
• Prince Kumar
• Archana Rautela
• Dr. Praveen Kumar Ashok

Regulatory affairs are a new profession that can be developed for the controlling the safety, quality and efficacy of the drug products by submitting the investigational new drug application (IND) and new drug application (NDA) to regulatory authority. 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 differences in timelines, requirements, and documentation. The main intention of this article was to aware the peoples towards the role of regulatory affairs department, requirements for new drug approval and the involvement of the regulatory professionals in this process as well as how crucial it is to perform and monitor the clinical and nonclinical trials of the drug before marketing the drug. In the present scenario, different countries have to follow different regulatory requirements for Marketing Authorization Application (MAA) approval of new drug. In this article, we studied the new drug approval process and regulatory requirements in India and US according to their Regulatory agencies.

Regulatory requirements, USFDA , CDSCO , Drug Approval, Clinical trials , MAA

"REGULATORY REQUIREMENTS AND DRUG APPROVAL PROCESS IN INDIA, EUROPE AND US ", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 5, page no.j618-j640, May-2025, Available :http://www.jetir.org/papers/JETIR2505A57.pdf

"REGULATORY REQUIREMENTS AND DRUG APPROVAL PROCESS IN INDIA, EUROPE AND US ", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 5, page no. ppj618-j640, May-2025, Available at : http://www.jetir.org/papers/JETIR2505A57.pdf