EMA Maps International Regulatory Coordination Initiatives
13 January 2017
The European Medicines Agency (EMA) has mapped cooperative regulatory initiatives to better understand how and where international peers are working together.
EMA found there were a “myriad of initiatives but no strategic coordination,” prompting it to warn regulators are duplicating efforts in some areas while overlooking other fields altogether.
Officials at EMA put together the report as part of their involvement in the International Coalition of Medicines Regulatory Authorities (ICMRA), an organization established to provide direction for common activities. Before ICMRA can provide such direction, it first needs to know how agencies are cooperating currently. Equipped with this knowledge, the coalition will be better placed to decide where it should focus its energy. The report suggests ICMRA has plenty of work to do to improve the situation.
“Mappings and analyses strongly support the need for a global strategy to support cooperation between international medicines regulators, to help avoid an overlap of activities and make resources available for areas where gaps still exist,” EMA wrote in its report.
EMA looked closely at three key areas of cooperation: supply-chain integrity, pharmacovigilance and crisis management. The agency identified ways to improve cooperation in each area.
The globalization of supply chains and the quality risks this creates have made their integrity a big area for international cooperation. In mapping these initiatives, EMA identified multiple areas of overlap, including databases, track and trace initiatives, alert systems and ways to ensure “single points of contact.” EMA also found a lack of mutual awareness and the inability to link different systems. Faced with this situation, the authors see value in trying to globalize track and trace systems and link databases and alert systems across borders.
EMA found a similar lack of mutual awareness and inability to link projects when it reviewed pharmacovigilance projects. The authors focused their review of cooperation in pharmacovigilance on the lack of projects using “big data technologies” to produce “a huge amount of post-marketing data” and create better predictive models. Overall, the authors see value in establishing “a more globally connected pharmacovigilance system,” but note data protection legislation and the current lack of coordination will make this a challenge.
Cooperation in the final focus area of the report, crisis management, is hamstrung by a “lack of common understanding among regulators of what a health crisis means,” according to the EMA authors. EMA has proposed a definition so international regulators can work together more effectively when safety issues, crisis-driven shortages and emerging health threats require more than routine measures to bring under control.