Kamaljit Singh Sandhe

Drug regulation is totality of all measures- Legal, administrative and technical- which the governments take to assure the quality, efficacy and safety of drugs. With reports of number of tragic adverse events caused by use of drugs, more stringent controls have been imposed upon the procedures for marketing authorization of drugs. The research and development, manufacture, import and export of pharmaceuticals is regulated by different regulatory bodies in different countries with varying levels of regulation stickiness. This review article provides useful information regarding the regulatory framework and Pharmaceutical key role players in many countries which are actively engaged in licensing and approval activities. Key Words: Drug regulation, Drug registration, Drug Approval, EMEA, Pharmaceuticals, USFDA.