ICH


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Structure of ICH

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. There are six parties directly involved as well as Observers and IFPMA.

ICH has administrative and technical functions. The ICH Steering Committee directs and oversees the work, with the assistance of six ICH Coordinators, who ensure contact and communication between the parties. The Steering Committee is also supported by a small Secretariat, provided by IFPMA.

The Steering Committee recieves technical advice from ICH Expert Working Groups of scientists. Within each of the six parties there are also extensive networks of contacts who are involved in discussions of the scientific issues



Three Regions, Six Parties


The six co-sponsors of ICH represent the regulatory agencies and the research-based pharmaceutical industry in the three ICH Regions, the European Union, Japan and the United States of America:

Each of the parties have two seats on the ICH Steering Committee

Observers

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

Role of IFPMA

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.

IFPMA Home Page

ICH Parties

European Commission - European Union (EU)

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 recently 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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European Federation of Pharmaceutical Industries' Associations (EFPIA)

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.
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Ministry of Health and Welfare, Japan (MHW)

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.
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Japan Pharmaceutical Manufacturers Association (JPMA)

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.
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US Food and Drug Administration (FDA)

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.
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Pharmaceutical Research and Manufacturers of America (PhRMA)

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 Mnufacturers 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.
PhRMA Home Page
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