ABSTRACT
I. THE ICH PROCESS The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project of the regulatory authorities of Europe, Japan, and the United States and of experts from the pharmaceutical industry in these three regions. The objectives are to establish internationally harmonized recommendations (ICH guidances) for the studies conducted to assure the quality, safety, and efficacy of pharmaceuticals. The six cosponsors of ICH are: (1) the Commission of the European Union (EU); (2) the European Federation of Pharmaceutical Industries Associations (EFPIA); (3) the Ministry of Health and Welfare, Japan (MHW); (4) the Japan Pharmaceutical
Manufacturers Association (JPMA); (5) the U.S. Food and Drug Administration (FDA); (6) the Pharmaceutical Research and Manufacturers of America (PhRMA). The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) serves as a coordinating institution for the pharmaceutical industry and provides the ICH secretariat. The World Health Organization, the European Free Trade Area, and Canada have an observer status in the ICH process. A steering committee with individuals from the represented parties of the three regions oversees and guides the harmonization process. In a first step, the ICH steering committee, in close cooperation with experts from the three regions, selects topics for which there is a realistic chance that a guidance acceptable in all three regions could be developed. Each regulatory party agrees to accept completed topical guidances as regulatory policy in their respective region. Thereafter, expert working groups (EWGs) are established to develop a guidance(s) on their topic. These EWGs consist of representatives of the six (three regulatory and three industrial) sponsoring parties. These experts are responsible for communication, consultation, scientific contact, and acceptance of decisions in their respective regions. The EWG creates a draft guidance (step 1) which, after several further steps of consultation (Fig. 1), is established as an ICH guidance to provide the necessary direction in the EU, Japan, and the United States (step 5). Once ICH guidances have been finalized and published, they are officially adopted in the three ICH regions and put into practice (Fig. 1). Detailed information on the ICH process, the decision-making process, and on guidance texts are available in the proceed-
FIG. 1. The ICH guidance development process
ings of the four ICH conferences (1-4). Guidances are also available from the internet at https://www.ifpma.org/ich1.html.
