A REVIEW ARTICLE ON: GENERAL CONSIDERATIONS FOR CLINICAL TRIALS (ICH EFFICACY TOPIC E8) AND MARKETING AUTHORIZATION
About Authors:
Vinay K. Gupta*, G. Rajan and Preeti Kothiyal
Shree Guru Ram Rai Institute of Technology & Science,
Patel Nagar, Dehradun
*vngupta74@gmail.com
Abstract
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has evolved, through its ICH Global Cooperation Group, to respond to the increasingly global face of drug development, so that the benefits of international harmonization for better global health can be realized worldwide. ICH's mission is to achieve greater harmonization to ensure that safe, effective and high quality medicines. This contains four main topic that are Quality, Safety, Efficacy and Multidisplinary. Here we are mainly explain general aspects of clinical trial that are related to ICH E8 and procedure for marketing authorization of new drug substance in India

