Sun, 17 Dec 2017

Drug Regulatory Bodies: Key Role Players in Different Regions

 

Kamaljit Singh Sandhe1, 2, Vikas Kumar Bhambhu2, Saahil Arora2, RSR Murthy2

 

1. Global Institute of Regulatory Affairs, Pune.

2. ISF college of Pharmacy, Moga (PUNJAB), India


 

ABSTRACT

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.

 


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