May 28, 2018
On April 16, 2018, heads of agencies gathered in Basel, Switzerland for the International Coalition of Medicines Regulatory Authorities (ICMRA) plenary meeting on the margins of the DIA Euromeeting. A total of over 40 attendees represented 23 agencies at the meeting, including leaders of the Agencies and representatives from the World Health Organization.
Challenges confronting medicines regulatory authorities are complex, wide ranging and global in nature. The day-long meeting provided a forum for senior representatives from Medicines Regulatory Authorities from around the world to share, discuss, and address issues and challenges. Heads of agencies also provided direction to progress the work on ICMRA strategic projects including supply chain integrity, pharmacovigilance, crisis management and the new innovation project. Reports on the findings and results of some of the work achieved by the ICMRA working groups have been published on the ICMRA website on Supply Chain Integrity – Track and Trace recommendations (for facilitating the interoperability of systems) and Pharmacovigilance Big Data Policy and Inventory paper ( on regulators’ big data initiatives). Further reports and recommendations on regulatory approaches to innovation, with respect to regulator’s horizon scanning methodologies, and novel approaches to licensing are currently being developed.
ICMRA will continue its endeavour to enable a global framework to support enhanced communication, information-sharing, coordinated crisis responses and increase awareness of and appreciation for the importance of strong regulatory systems and functions.