Final answer:
The six regulatory and pharmaceutical industry groups involved in ICH are the EMA (EU), FDA (USA), MHLW and PMDA (Japan), along with EFPIA (Europe), PhRMA (USA), and JPMA (Japan). They collaborate on harmonising regulatory requirements for pharmaceuticals.
Step-by-step explanation:
The International Conference on Harmonisation (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use is a unique project that brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.
The six regulatory and pharmaceutical industry groups that have representatives working for ICH include:
- The European Medicines Agency (EMA), which represents the European Union.
- The Food and Drug Administration (FDA), representing the United States.
- Japan's Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA), representing Japan.
- Plus three industry associations from these regions:
- The European Federation of Pharmaceutical Industries and Associations (EFPIA) for Europe.
- The Pharmaceutical Research and Manufacturers of America (PhRMA) for the USA.
- The Japan Pharmaceutical Manufacturers Association (JPMA) for Japan.
These groups work together within ICH to achieve greater harmonisation to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.