The ICH is a common project of regulatory authorities and representatives of pharmaceutical industries in EU, Japan and the US.
Its mission is to discuss issues related to approval and marketing authorization of new medicinal products in these three regions.
Namely, the six parties involved are the:
- European Commission
- The European Federation of Pharmaceutical Industry Associations
- The Japanese Ministry of Health and Welfare
- The Japanese Pharmaceutical Manufacturers Association
- The US FDA
- The US Pharmaceutical Manufacturers Association
In addition to these principals, there are three observers representing non-ICH countries:
- World Health Organisation (WHO)
- The European Free Trade Association (EFTA)
- Health Canada
Primary Objective
The primary objective of ICH is to harmonize regulatory requirements related to quality, safety and efficacy of medicinal products and to support mutual recognitions between the three regulatory authorities.
Exchange of Data
Mutual recognitions are based on the exchange of data and assessment reports which are intended to eliminate duplicative testing and inspection procedures, and thus decrease costs of, and speed up, the introduction of new medicinal products to the markets.
