ABOUT AUTHOR:
Mr. Vivek P. Chavda, Dr. Moinuddin M. Soniwala
Department of Pharmaceutics, B.K. Mody Government Pharmacy College,
Rajkot – 360003, Gujarat (India)
vivek7chavda@gmail.com
INTRODUCTION1,2
In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) was organized in April 1990 and has as its sole and primary purpose the creation of international standards for the purpose of pharmaceutical research. This process was initiated in order to harmonize the submission requirements for new pharmaceuticals in the three main regions of Europe, the United States, and Japan and to avoid duplication, inefficiencies and delays.
The six cosponsors of ICH were
- European Commission,
- European Federation of Pharmaceutical Industry Association (EFPIA),
- Japanese Ministry of Health (MHW),
- Japanese Pharmaceutical Manufacturers Association (JPMA),
- Food and Drug Association (FDA), and the Pharmaceutical Research
- Manufacturers of America (PhRMA)
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