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 :

Regulatory bodies


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.
PMID: 26618810

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.
PMID: 26014592