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EMA’s update on Mutual Recognition Agreements

In April EMA’s Quality and Safety of Medicines Department published the annual report (EMA/INS/GMP/706144/2021) of the GMP/GDP Inspectors Working Group (GMP/GDP IWG) for the year 2021. The GMP/GDP IWG provides input and recommendations on all matters relating directly or indirectly to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). The GMP/GDP IWG focuses on harmonisation and co-ordination of GMP and GDP related activities at EU level and maintains close co-operation with international partner authorities. This is the first annual report published after 2017, since there was no annual reporting from 2018 to 2020 because of the EMA Business Continuity Plan (BCP) due to the effects of the UK withdrawal from the European Union. The BCP was extended in 2020 due to the public health emergency due to COVID-19.

This annual report is set out in line with the format and objectives of the 2021 – 2023 three-year work plan and gives among other topics a detailed update on all existing MRAs:

  • MRA with the USA; work continues the inclusion of veterinary medicines in the scope of the agreement. Preparatory work on the modalities and scope of an FDA assessment for extending the MRA to vaccines and plasma products has now begun. However, work on the inclusion of pre-approval inspections has been deferred;
  • MRA with Canada; the Comprehensive Economic Trade Agreement (CETA) was provisionally applied in September 2017 pending ratification by all EU member states.  The provisions of the existing MRA were thereby integrated into CETA, with the addition of voluntary recognition of inspections by third countries. The EU assessment of Canada for “API listing” and inclusion of active substances in the MRA continued in 2021. Mutual recognition of GMP inspections conducted outside the territory of the Parties was implemented in April 2021;
  • MRA with Japan, Switzerland, Australia, New Zealand and Israel (ACAA); no changes;
  • International cooperation with the UK in the field of GMP; the Trade and Cooperation Agreement concluded between the EU and the United Kingdom (UK) applies provisionally from 1 January 2021, pending ratification procedures. The agreement includes a specific annex on medicinal products, which regulates the recognition of the results of GMP inspections by EU and UK authorities. The UK participated as an observer in all four GMP/GDP IWG meetings in 2021.