EU trade groups propose criteria for determining new location of EMA

In a joint letter, three European pharmaceutical trade associations have said that, following Brexit, EMA relocation mustn’t negatively impact the regulatory capacity, processes or timeframe for approval of new and the maintenance of existing medicines. The current regulatory system that safeguards public health and patient safety in the EU must not be adversely affected.

In the letter the groups present six essential criteria for deciding where the European Medicines Agency (EMA) should move to. The criteria are:

  • The capacity of the national competent authority to support the EMA’s work (as currently the Medicines and Healthcare Products Regulatory Agency (MHRA) plays a key role in EU drug applications and procedures).
  • The ability of the national competent authority to continue with non-EMA activities such that these are not adversely affected.
  • The size and breadth of the pool of local scientific and medical research expert pool to support regulatory work.
  • A central location with sufficient hotel and meeting capacity.
  • Accessibility and connectivity with strong transport links to ensure easy access.
  • Minimal disruption for EMA staff with appropriate support with the aim of ensuring that EMA staff levels do not drop negatively affecting the EMA’s ability to perform its role.

 

While the letter does not advocate a particular city or country, the criteria seem to favour countries in Western Europe with a larger regulatory agency.

To read the letter, please click here.