MHRA: UK an Active Member of EU Networks ‘Until we Left the EU’

Regulatory NewsRegulatory News | 03 November 2016 |  By 

In its annual accountability review, the UK’s Medicines & Healthcare products Regulatory Agency told the Parliamentary Under Secretary of State for Health that the UK “remained an active member of EU regulatory networks until we left the EU.”

MHRA work with the EMA has been extensive, and according to the minutes of the meeting on 20 October, “was highly valued. The MHRA was working closely with stakeholders, including industry, to fully consider all the options for regulation of medicines, devices and blood products following Brexit.”

MHRA chief executive Dr. Ian Hudson explained its close working relationship with EMA via its:

  • permanent membership on the EMA Management Board;
  • developing the EU Medicines Agencies Network Strategy to 2020;
  • collaborating on EU laws and initiatives;
  • working with EMA and its scientific committees, including chairing three of the five scientific committees and leading on marketing authorizations within member states;
  • acting as rapporteurs/co-rapporteurs for 20 centralized procedures granted marketing authorization in Europe;
  • leading 96 European Scientific advice meetings, shaping regulation and approvals across Europe.

“Attendees discussed the major strategic challenges facing the MHRA. The foremost of these would be the implications for MHRA of the UK’s exit from the European Union,” the minutes said.

The agency detailed other important efforts the agency has undertaken in 2015-2016, including the signing of a Memorandum of Understanding with the Indian Central Drugs Standard Control Organisation, and its help in developing 15 World Health Organization international standards to “underpin consistent manufacture and accurate measurement of biological medicine and diagnostics, including standards for Ebola and several other ‘first in class’ materials.”

Annual Accountability Review 2015-2016


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