News about GMP/cGMP


Expansion of MRA between Japan and EU

According to the published 15-page document that summarises the negotiating results of the Economic Partnership Agreement between the EU and Japan, the MRA (Mutual Recognition Agreement) in the area of GMP will be expanded to new pharmaceutical products.

This is considered a major achievement after numerous attempts and years of discussion. It should bring immediate and substantial benefits to the pharmaceutical industries for which Japan is one of the key markets. The expansion would also include active pharmaceutical ingredients and biological pharmaceuticals,  including  immunologicals and vaccines.  Both Parties aim to complete all the formal procedures in the next few weeks, which would allow the entry into force of the new expanded product scope.


EU-Japan EPA – The Agreement in Principle