Chemistry Reference
In-Depth Information
1.4.1.1 european commission of the european union (eu)
The European Commission represents the fifteen members of the European Union
and is currently working, through harmonization, to achieve a single market to allow
free movement of products throughout the EU. The European Medicines Agency
(EMEA), based in London, was created by the European Commission to provide
technical and scientific support for ICH activities.
1.4.1.2 european Federation of pharmaceutical
Industries and Associations (eFpIA)
The EFPIA is based in Brussels and counts member associations in sixteen coun-
tries in Western Europe among its members. Members also include all of Europe's
major research-based pharmaceutical companies. Much of the federation's work is
concerned with the activities of the European Commission and the (EMEA), and is
accomplished by a network of experts and country coordinators that ensure that the
EFPIA's views within ICH are representative of the European pharmaceutical industry.
1.4.1.3 ministry of Health and Welfare, Japan (mHW)
In Japan, the MHW is responsible for the improvement and promotion of social
welfare, social security, and public health. Within the MHW, the Pharmaceutical
Affairs Bureau is responsible for reviewing and licensing all medicinal products
and acts as the focal point for ICH activities. Technical advice on ICH matters is
obtained through the MHW's expert groups, together with an affiliated organization,
the National Institute of Health Sciences.
1.4.1.4 Japan pharmaceutical manufacturers Association (JpmA)
The membership of the JPMA represents ninety research-based pharmaceutical man-
ufacturers in Japan. Within the JPMA, ICH activities are coordinated through special-
ized committees of industry experts who participate in the ICH expert working groups.
1.4.1.5 us Food and drug Administration (FdA)
The 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, the FDA is responsible for the approval of all drug products used in the
United States, regardless of origin. The FDA consists of administrative, scientific,
and regulatory staff organized under the Office of the Commissioner and has sev-
eral centers with responsibility for various regulated products. Technical advice and
experts for ICH activities are drawn from both the CDER and CBER.
1.4.1.6 pharmaceutical research and manufacturers of America (phrmA)
PhRMA represents the research-based pharmaceutical industry involved in the
discovery, development, and manufacture of prescription medicines in the United
States. There are also research affiliates, members that 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 com-
mittees of experts from PhRMA companies deal specifically with ICH topics.
