European Federation of Pharmaceutical Industries and Associations (EFPIA) is situated in Brussels and has direct membership of 29 national pharmaceutical industry associations and 44 leading pharmaceutical companies. EFPIA is the voice on the European scene of about 1900 companies committed to researching, developing and bringing to patient’s new medicines that improve health and the quality of life around the world.
The Ministry of Health, Labour and Welfare, Japan (MHLW). Affiliated institutions include the National Institute of Health Sciences (NIHS) and academia which carries out research and testing on drugs, vaccines and biologicals. Technical advice on ICH matters is obtained through MHLW's regulatory expert groups, with members from NIHS.
Japan Pharmaceutical Manufacturers Association (JPMA) represents 90member companies. Membership includes all the major research-based pharmaceutical manufacturers in Japan. ICH work is coordinated through specialised committees of industry experts who also participate in the Expert Working Groups.
US Food and Drug Administration (FDA) has a wide range of responsibilities for drugs, biologicals, medical devices, cosmetics and radiological products. The largest of the world's drug regulatory agencies FDA is responsible for the approval of all drug products used in the USA. Technical advice and experts for ICH work are drawn from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.
Pharmaceutical Research and Manufacturers of America (PhRMA) represents the research-based industry in the USA. PhRMA coordinates its technical input to ICH through its Scientific and Regulatory Section. Special committees have been set up using experts from member companies to deal with ICH topics.
Observers. Since ICH was initiated in 1990 there have been observers associated with the process to act as a link with non-ICH countries and regions. These are currently: the World Health Organisation (WHO), The European Free Trade Area (EFTA), represented at ICH by Switzerland; and Canada, represented at ICH by the Drugs Directorate, Health Canada. Each of the Observer parties has a seat on the ICH Steering Committee.
