International Conference on Harmonisation
ICH is a a joint initiative involving both regulators and industry as equal partners in the scientific and technical discussions of the testing procedures which are required to ensure and assess the safety, quality and efficacy of medicines.
The focus of ICH has been on the technical requirements for medicinal products containing new drugs. The vast majority of those new drugs and medicines are developed in Western Europe, Japan and the United States of America and therefore, when ICH was established, it was agreed that its scope would be confined to registration in those three regions.
There are Six Parties directly involved as well as Observers and IFPMA.
The Six Parties are the founder members of ICH which represent the regulatory bodies and the research-based industry in the European Union, Japan and the USA: EU, EFPIA, MHW, JPMA, FDA and PhRMA
The European Commission represents the fifteen members of the EU. The Commission is working, through harmonisation of technical requirements and procedures, to achieve a single market in pharmaceuticals which would allow free movement of products throughout the EU.
The European Agency for the Evaluation of Medicinal Products has been established by the Commission and is situated in London. Technical and scientific support for ICH activities is provided by the Committee for Proprietary Medicinal Products (CPMP) of the EMEA.
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EFPIA, is situated in Brussels and has, as its members, Member Associations in sixteen countries in Western Europe. Much of the Federation's work is concerned with the activities of the European Commission and the new EMEA.
Companies in membership of EFPIA are manufacturers of prescription medicines and include all of Europe's major research-based pharmaceutical companies.
A wide network of experts and country coordinators has been established, through Member Associations, to ensure that EFPIA's views within ICH are representative of the European industry.
MHW is responsible for the improvement ofand promotion of social welfare, social security and public health. One of its nine bureaux is the Pharmaceutical Affairs Bureau within which is the Pharmaceuticals and Cosmetics Division. This Division is responsible for review and licensing of all medicinal products and cosmetics. It acts as the focal point for ICH activities.
Affiliated institutions include the National Institute of Health Sciences and academiawhich carries out research and testing on druggs, vaccines and biologicals.
Technical advice on ICH matters is obtained through MHW's regulatory expert groups, with members from NIHS.
JPMA represents ninety member 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.
Among the objectives of JPMA is the development of a competative pharmaceutical industry with a greater awareness and understanding of international issues. JPMA promotes and encourages the adoption of international standards by its member companies.
The US Food and Drugs Administration 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.
The FDA consists of administrative, scientific and regulatory staff organised under the Office of the Commissioner and has several Centers with responsibility for the various products which are regulated. 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.
The Pharmaceutical Research and Manufacturers of America - PhRMA - represents the research-based industry in the USA. The Association has sixty-seven companies in membership which are involved in the discovery, development and manufacture of prescription medicines. There are also twenty-four research affiliates which conduct biological research related to the development of drugs and vaccines.
PhRMA, which was previously known as the US Pharmaceutical Manufacturers Association (PMA), coordinates its technical input to ICH through its Scientific and Regulatory Section. Special committees have been set up, of experts from PhRMA companies, to deal with ICH topics.
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Since ICH was initiated, in 1990, there have been observers associated with the process, to act as a link with non-ICH countires and regions. The Observers to ICH are:
Each of the Observer parties has a seat on the ICH Steering Committee
The International Federation of Pharmaceutical Manufacturers Association (IFPMA) is a Federation of Member Associations representing the research-based pharmaceutical industry and other manufacturers of prescription medicines in 56 countries throughout the world. IFPMA has been closely associated with ICH, since its inception to ensure contact with the research-based industry, outside the ICH Regions. IFPMA has two seats on the ICH Steering Committee and runs the ICH Secretariat. (See Committees)
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ICH is administered by the ICH Steering Committee which is supported by the ICH Secretariat. Since ICH was established, each of the six co-sponsors has had two seats on the ICH Steering Committee (SC) which oversees the harmonisation activities. IFPMA provides the Secretariat and participates as a non-voting member of the Steering Committee.
The Observers, WHO, the Canadian Health Protection Branch, and the European Free Trade Association (EFTA) nominate participants to attend the ICH Steering Committee Meetings.
For further information on the Membership of the ICH Steering Committee, see Committees
Fundamental to the smooth running of ICH has been the designation, by each of the six co-sponsors, of an ICH Coordinator to act as the main contact point with the ICH Secretariat and ensure that ICH documents are distributed to the appropriate persons within the area of their responsibility. Each party has also established a Contact Network of experts within their own organisation or region in order to ensure that, in the discussions, they reflect the views and policies of the co-sponsor they represent. The way in which this network operates differs according to the administrative structure of the party concerned.
Contact names and addresses for the ICH Coordinators are given on the Committee page.
The ICH Secretariat
The Secretariat operates from the IFPMA offices, in Geneva, and is primarily concerned with preparations for, and documentation of, meetings of the Steering Committee as well as coordination of preparations for EWG meetings and six-party drafting groups. At the time of ICH Conferences, the Secretariat is responsible for the technical documentation and for liaison with the speakers for the Conference. Organisational aspects of the Conferences are handled by the industry and regulatory parties in the country where the Conference takes place.
Contacts for the Secretariat are given on the Committee page. The Secretariat can be contacted by E-mail on firstname.lastname@example.org
Conferences and Workshops
When ICH was first established, one of the objectives was to organise an International Conference on Harmonisation, and hence the name which was given to the initiative.
The name of ICH has now, perhaps, become more associated with the process of harmonisation, than the actual Conferences, although these have been extremely important for ensuring that the process of harmonisation was carried out in a transparent manner and that there was an open forum in which to present and discuss ICH recommendations. The first Conference was held in Brussels, 1991, followed by ICH 2, Orlando, Florida, 1993, ICH 3, Yokohama, Japan 1995 and the Fourth International Conference on Harmonisation, July 1997, was once again in Brussels.
Regional Workshops on the implementation and use of the ICH Guidelines have occasionally been organised by ICH parties, at the time of a Steering Committee meting in the region, in order to benefit from the presence of SC Members and ICH Experts. It is envisaged that such Workshops will continue to be organised and will provide an opportunity for interaction with all "users" of the guidelines.
Copyright© 1998 International Federation of Pharmaceutical Manufacturers Associations