News on the various Mutual Recognition Agreements (MRAs)
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On 19 April, the "Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2021" was published. This annual report of the GMP/GDP Inspectors Working Group (GMP/GDP IWG) gives a short but good overview of what was new in 2021.
Among other things, the update on all existing MRAs is interesting. Here is the overview:
MRA with the USA
Work continues on 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 Japan
No changes In 2021.
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 Switzerland
No changes In 2021.MRA with Australia
No changes In 2021.MRA with New Zealand
No changes in 2021.ACAA with Israel
No changes in 2021.
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 Good Manufacturing Practice (GMP) inspections by EU and UK authorities. The UK participated as an observer in all four GMP/GDP IWG meetings in 2021.