M. Suresh Babu*, Abdul Mannan, Mohd Moin, Salman Abdul Majeed, Mohammad Mujju and Mohd Ameenuddin Khan


The person is responsible for knowing the regulatory requirements for getting new products approved. They know what commitments the company has made to the regulatory agencies where the product has been approved. Clinical trials (CTs) are conducted to explore new methods of intervention that are better than the existing ones and can also be easily tolerated by patients. CTs are conducted in accordance with the regulatory guidelines recommended for the same by the drug regulatory authority of the country where they have to be conducted. In USA, CTs are regulated by USFDA as per their 21 code of federal regulations part 312 (CFR) of Federal Food, Drug, and Cosmetic act. In EU, they are regulated by European Commission and EMA as per their CT directive 2001/20/EC of the European Parliament and of the council of 4 April 2001 and GCP directive 2005/28/EC of 8 April 2005. In India, they are regulated by CDSCO (Schedule Y of the Drug and Cosmetics Rules, 1945) and ICMR (Ethical Guidelines for Biomedical Research on Human Subjects), respectively. The role of these authorities is to ensure the quality, safety, and effectiveness of all medicines in their respective countries. In this work, clinical trial regulations in USA, EU and India were compared on the basis of parameters such as regulatory bodies involved, regulations for CTs, clinical trial application format, application fee, approval time, the various forms required, role and responsibilities of IRB/IEC, record retention time, and GCP guidelines. The success rate of CTs in USA and Europe is higher in comparison to India which may be due to well-trained investigators, fast regulatory approval process and volunteer participation by the subjects. Some case studies related to the clinical trials conducted in these countries have also been incorporated.

Keywords: Clinical Trails, Regulatory requirements, USA, EUROPE, INDIA.

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