HISTORY OF ICH
The ICH initiative started in November 1991 in Brussels. The purpose of this initiative was to bring together regulatory agencies and experts from the pharmaceutical industry of the three largest markets (Europe, Japan and the United States of America) in an effort to harmonise regulatory requirements for the registration of new human therapeutics. If harmo- nisation could be achieved without compromising the quality, efficacy and safety of medicinal products, then much of the repeat testing required to register a product in the three regions would be reduced or eliminated.
The aims of the ICH pro-cess are to:
● Unify the registration requirements for new medicinal products
● Accelerate medicinal product licensing times
● Reduce medicinal product development costs
● Increase patent protection times
Organisation of ICH
The ICH organisation involves representatives from three principal re-gions the European Union, Japan and the United States of America, with the assistance of observers from the World Health Organisation (WHO), the European Free Trade Association (EFTA) and the Canadian Health Protection Branch. There are six co-sponsors of the ICH process, two from each of the following geographical regions: Europe
Expert Working Groups
The Expert Working Groups (EWGs) consist of joint regulatory and indus-try representatives nominated by the six ICH co-sponsors. Several EWGs are appointed to advise the steering committee on topics for the harmo- nisation process. These topics are grouped under four areas:
1. Quality
2. Efficacy
3. Safety
4. Multidisciplinary (Cross-topics)
The ICH initiative started in November 1991 in Brussels. The purpose of this initiative was to bring together regulatory agencies and experts from the pharmaceutical industry of the three largest markets (Europe, Japan and the United States of America) in an effort to harmonise regulatory requirements for the registration of new human therapeutics. If harmo- nisation could be achieved without compromising the quality, efficacy and safety of medicinal products, then much of the repeat testing required to register a product in the three regions would be reduced or eliminated.
The aims of the ICH pro-cess are to:
● Unify the registration requirements for new medicinal products
● Accelerate medicinal product licensing times
● Reduce medicinal product development costs
● Increase patent protection times
Organisation of ICH
The ICH organisation involves representatives from three principal re-gions the European Union, Japan and the United States of America, with the assistance of observers from the World Health Organisation (WHO), the European Free Trade Association (EFTA) and the Canadian Health Protection Branch. There are six co-sponsors of the ICH process, two from each of the following geographical regions: Europe
- The Commission of the European Communities (CEC)
- The European Federation of Pharmaceutical Industries Association (EFPIA)
- The Ministry of Health and Welfare (MHW)
- Japan Pharmaceutical Manufacturers Association (JPMA)
- USA Food and Drug Administration (FDA)
- Pharmaceutical Research and Manufacturers Association (PhRMA)
Expert Working Groups
The Expert Working Groups (EWGs) consist of joint regulatory and indus-try representatives nominated by the six ICH co-sponsors. Several EWGs are appointed to advise the steering committee on topics for the harmo- nisation process. These topics are grouped under four areas:
1. Quality
2. Efficacy
3. Safety
4. Multidisciplinary (Cross-topics)
