Conference on Harmonization Guidelines

The ICH was created around 1990 and is concerned with the harmonization of technical requirements for the registration of products among these three major markets. The terms of reference of the ICH are as follows  

The ICH is a joint regulatory/industry undertaking and the six co-sponsors of the conference are 

Europe European Commission (EC) and the European Federation of Pharmaceutical Industry Associations (EFPIA) 

Japan Ministry of Health and Welfare (MHW) and the Japanese Pharmaceutical Manufacturers Association (JPMA) 

United States Food and Drug Administration (FDA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) 

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International Conference on Harmonization, Guideline on validation of analytical procedures definition and terminology, Fed. Reg., 60(40), 11260 (1995). 

FDA International Conference on Harmonization Guideline on detection of toxicity to reproduction for medicinal products. Federal Register, September 22, 1994, Vol. 59, No. 183. 

Source International Conference on Harmonization. Guideline for Good Clinical Practice E6(R1). http //www.ich.org/LOB/media/MEDIA482.pdf [accessed September 17,2007]. 

International Conference on Harmonization Guideline on Data Elements for Transmission of Individual Case Safety Reports. This document s efforts focus on quality control/quality assurance endeavors to ensure accuracy and to promote validation in the handling of case safety reports for both preapproval and postapproval periods. It covers both adverse drug reaction and adverse event reports. 

International Conference on Harmonization. Guidelines for the PhotostabUity Testing of New Drug Substances and Products. FR 1997 62 27115-27122. 

ICH. 1996. International Conference on Harmonization Guideline on Structure, Content and Clinical Study Reports availability notice . Federal Register 61(138) 37326. 

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