A Review on Pharmaceutical Regulatory Agencies of India, USA and Europe

R. SWETHA SRI , CH. MOUNIKA , Dr. K.BHAVYA SRI

Regulatory Agency, CDSCO, US FDA, EMA, Marketing Authorization Application, Common Technical Document

Drugs play a major role in saving lives, maintaining health, preventing diseases, stopping epidemics and in improving economy of a country. Therefore, people, government, pharmaceutical industries and research institutes spend money on drugs. However, in order to do so, drug must be safe, effective and of good quality. This means the development, production, importation, exportation, and distribution of drugs are regulated to ensure that they meet prescribed standards. For effective regulation of pharmaceutical products, governments establish strong National Regulatory Authorities (NRAs), to assure that medicines are regulated effectively thereby protecting and promoting public health. Pharmaceutical regulations across the globe play a vital role in guaranteeing the safety, quality and efficacy of the drugs. Pharmaceutical regulatory agency is accountable to enforce the regulations and issue guidelines for drug development, licensing, registration, producing, labelling, storage, marketing, distribution, pricing of drugs, import and post marketing studies of pharmaceutical products. Pharmaceutical industries, while pursuing an international market, must comply with pharmaceutical regulations of other countries, which have different regulatory requirements. A single regulatory approach for Marketing Authorization Application (MAA) of a drug product applicable to different countries is difficult. Therefore, Common Technical Document (CTD) was developed to provide a common format for submission of applications electronically for registration of pharmaceuticals. In this review article, an overview of pharmaceutical regulatory agencies of three countries: India, USA and Europe is covered.

Volume 5 Issue 3, March-2020

Pages : 134 - 143