Abstract

DRUG REGULATORY AFFAIRS: AN INSIGHTS ON REGULATORYAUTHORITIES OF VARIOUS COUNTRIES

Prof. Amol Pawar, Harshada Patil and Mayur Sanjay Desale*

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Abstract

Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for Marketing Authorization Application (MAA) approval of new drugs. Every country has its own regulatory authority which is responsible to enforce the rule sand regulations and issue the guidelines to regulate the marketing of the drugs. Once a lead drug molecule has been discovered, non clinical studies of a drug should be conducted to efficacy and safety. Then, clinical trials can be performed, after an application is submitted to competent authority of the concerned country. The three phases of clinical trials are conducted as per the protocol. The competent authority reviews an application submitted to get approval for marketing the drug and approves it if satisfied that the drug supports quality, safety and efficacy concerns. Even after the approval of new drug, government should monitor its safety by post marketing surveillance which is considered as Phase IV. Though certain aspects of drug approval process are similar among different countries, some differences do occur. In this present exertion study expresses the drug approval process and regulatory requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO), Therapeutic Goods Administration (TGA), Ministry of Health, Labor and Welfare (MHLW), State Food and Drug Administration (SFDA), Health Canada. This review out lines advances in therapy and the mains pot light for the improvement and advance of cell therapies that are being confronted today. This project focuses on history, regulatory policy and administration, and related issues with respect to different countries like India, Japan, China, Europe, US, Australia, Brazil and Canada.

Keywords: Regulatory Requirements:-USFDA, CDSCO, TGA, MHLW, SFDA, EMA, ANVISA.