15/16 February 2022
Besides other sections of the Economic Partnership Agreement between the EU and Japan, the Mutual Recognition Agreement on Good Manufacturing Practice to new pharmaceutical products (MRA) will also be amended. This was communicated in a summary by the EU Commission. However the process is not finalised yet and some parts of the agreement still need "fine tuning" and final agreement. Once the agreement in principle will be confirmed by the leaders of the EU and Japan, the respective document will be officially published.
The extended scope of the MRA will include active pharmaceutical ingredients (APIs), biologics, vaccines and immunologicals. This is a "major achievement after numerous attempts and years of discussion". It is expected that this will bring "substantial benefits" to the pharmaceutical industries in both areas. It is planned to complete all the formal procedures soon to allow the entry into force.