International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use: Difference between revisions

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.

The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration.

Harmonisation would lead to a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health.

History

In the 1980s, what is today the European Union began harmonising regulatory requirement. In 1989, Europe, Japan, and the United States began creating plans for harmonisation; ICH was created in April 1990 at a meeting in Brussels, Europe.

Structure

Six parties that represent the regulatory bodies and the research-based industries of the founding members are responsible for the decision making process: the European Union, the The European Federation of Pharmaceutical Industries and Associations (EFPIA), the Ministry of Health, Labour and Welfare, the Japan Pharmaceutical Manufacturers Association (JPMA), the Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA).

See also

• Harmonization in clinical trials
• Good clinical practice (GCP)
• Common Technical Document (CTD)
• Regulation of therapeutic goods
• Uppsala Monitoring Centre
• Council for International Organizations of Medical Sciences
• CIOMS Guidelines
• European Medicines Agency
• Clinical trial

External links

• Official ICH website