Applied Clinical Research, Clinical Trials and Regulatory Affairs

Satish Chandra
Tawam Hospital
Al Ain


Drug Approval Process – In United States of America, European Union and India: A Review

Author(s): Anjan K. Mahapatra, N.H. Sameeraja and P.N. Murthy

Affiliation: Dept. of Pharmaceutical Technology, Maharajah’s College of Pharmacy, Vizianagaram -535002, India.


The regulatory process, by which a person or an organization or a sponsor or an innovator gets authorization to launch a drug in the market, is known as drug approval process. Every country has its own regulatory authority, which is responsible to enforce the rules and 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 ensure 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. To overcome the difficulties due to these differences in various countries, the practice of Common Technical Document (CTD) has been introduced by the International Conference on Harmonization (ICH). The CTD helps to harmonize the format of the documents submitted for drug approval worldwide. This article highlights the history, regulatory agencies and policies, and related issues of United States of America, Europe and India.

Keywords: Marketing approval, non-clinical studies, clinical trials, post marketing surveillance, evaluation agency, common technical document (CTD), United States of America, Europe, India, International Conference on Harmonization (ICH), regulatory process.

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Article Details

Page: [13 - 22]
Pages: 10
DOI: 10.2174/2213476X01666140123234357