FDA-EMA Collaboration in Pharmacovigilance

By William Chin, PhD, Scientific Coordinator, EUCRAF

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published an article entitled "The US Food and Drug Administration-European Medicines Agency Collaboration in Pharmacovigilance: Common Objectives and Common Challenges" in the January 2015 issue of Drug Safety. The article reports the formation of a pharmacovigilance cluster on the 19 February 2014. This cluster formalizes the longstanding collaboration between the two agencies on post-marketing safety topics, primarily on product-specific issues, as well as on practical approaches to monitoring the safety of marketed medicines.  The pharmacovigilance cluster is meant to complement activities of the World Health Organization (WHO), the Council of International Organisation of Medical Sciences (CIOMS), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and the Drug Information Association (DIA). The cluster aims to promote information sharing and rigorous scientific exchange without pressure to achieve consensus on decision about any particular issue. 

Source

1.  Gerald J. Dal Pan, Peter R. Arlett, Drug Saf. 2015 Jan;38(1):13-5. doi: 10.1007/s40264-014-0259-3. The US Food and Drug Administration-European Medicines Agency Collaboration in Pharmacovigilance: Common Objectives and Common Challenges.