Pharmacogenetics
Appendix 2: List of regulatory authorities UK
Medicines and Healthcare products Regulatory Agency (MHRA) Previously two separate bodies: the Medicines Control Agency (MCA) and Medical Devices Agency (MDA)
- Executive agency of the Department of Health
- Assesses the quality, safety and efficacy of medicines, issues licences and monitors medicines and medical devices, including genetic tests Committee on the Safety of Medicines (CSM)
- Independent
- Advises MCA and assists in monitoring licensed medicines Human Genetics Commission
- Superseded the Advisory Committee on Genetic Testing which had produced a voluntary code of practice on genetic testing services supplied directly to the public.
- Published Genes Direct, a report on the provision of genetic tests directly to the public in 2003. Europe European Medicines Evaluation Agency (EMEA)
- Responsible for licensing and monitoring medicines in the European Union Committee for Proprietary Medicinal Products (CPMP)
- Subcommittee of the EMEA US US Food and Drug Administration (FDA)
- Assesses efficacy and safety of medicines and devices International International Conference on Harmonisation
- A joint initiative involving the regulatory authorities of Europe, Japan and the US and experts from the pharmaceutical industry, which aims to achieve greater harmonisation in the interpretation and application of technical guidelines and regulation regarding medicines.