Achieving the goals of precision medicine (PM) will require advancing the regulatory frameworks. Regulatory bodies such as the European Medicines Agency, the U.S. Food and Drug Administration (FDA), and the French National Agency for Medicines and Health Products need to ensure that PM products are safe and effective.
On this page, we provide regulatory informations related to Precision Medicine :
- U.S. Food and Drug Administration (FDA)
- European Medicines Agency
- UK – The Medicines and Healthcare Products Regulatory Agency (MHRA)
- France – French National Agency for Medicines and Health Products
USA – The Food, Drug, and Cosmetic Act (“FDCA”)
USA – The Drug Quality and Security Act (DQSA)
Europe – European Science Foundation (ESF) – Personalised Medicine for the European Citizen – October 2012
The Legal Environment for Precision Medicine.
Thompson B, Boiani J.
Clin Pharmacol Ther. 2015 Nov 30. doi: 10.1002/cpt.303.
The FDA and genomic tests–getting regulation right.
Evans BJ, Burke W, Jarvik GP.
N Engl J Med. 2015 Jun 4;372(23):2258-64.
doi: 10.1056/NEJMsr1501194. Epub 2015 May 27.