EMA publishes regulatory initiatives mapping report

As part of the International Coalition of Medicines Regulatory Authorities (ICMRA), the European Medicines Agency (EMA) has mapped a variety of ongoing regulatory initiatives.

In December 2013, ICMRA was formed by the heads of regulatory authorities from across the globe. ICMRA aims to develop strategies to address current and emerging challenges in global human medicine regulation. One of the aims of the coalition is to identify ways to better use existing initiatives and resources to tackle shared problems. In addition to identifying such activities, work areas for this first mapping exercise included generic medicines, good manufacturing practice (GMP) inspections and means of exchanging of confidential information, supply-chain integrity, crisis management and pharmacovigilance.

The mappings were produced from publicly available information, EMA’s existing knowledge and input from other ICMRA members. This report describes the mapping activities performed from February 2014 to December 2015; the results of the analyses and how this work will steer ICMRA efforts in the future.

So what does the report show? The EMA found there were a “myriad of initiatives but no strategic coordination,” causing it to warn that there is duplication of effort in some areas and no activity in others. The focus and membership of the various initiatives was seen to be highly variable. The exercise show there is a strong need for a global strategy to support cooperation between international regulatory agencies, “to help avoid an overlap of activities and make resources available for areas where gaps still exist.”

The EMA identified various issues and suggested means by which cooperation could be improved for some key areas:

Supply chain integrity – A total of 14 different initiatives were included. The mapping exercise identified multiple areas of overlap, including databases, track and trace initiatives, alert systems and ways to ensure “single points of contact”, whereas noted gaps were a lack of mutual awareness and the inability to link different systems. Raising mutual awareness, promoting synergies and avoiding duplication were identified as opportunities for regulators.

Pharmacovigilance – 18 projects were reviewed and the EMA reported a similar lack of mutual awareness and inability to link projects. A specific gap in this area was identified as the lack of use of ‘big data’ or real world evidence and create better predictive models. The report calls for a more globally connected pharmacovigilance system, increased transparency and more rapid information exchange although it is noted that data protection legislation and issues with sharing confidential information will make this difficult.

Crisis management – Collaboration in this area is made challenging by a lack of common understanding among regulators of what a health crisis is so the EMA has proposed a definition. Hopefully, this will allow international regulators to identify when a crisis occurs and enable them to work together more efficiently.

The EMA says that mappings need to be considered as ‘living documents’ based on information available at the time of production so we might well see them amended in the future as new initiatives emerge or existing ones are modified. The document provides a useful resource to identify ongoing regulatory initiatives. Furthermore, suggestions on the published mappings can be submitted electronically via EMAinternational@ema.europa.eu and will be taken into consideration for future revision.

Click here to access the report.