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MRA expands between Japan and EU

Mutual Recognition Agreement (MRA) between Japan and EU in the area of good manufacturing process (GMP) has been amended besides working on other sections of Economic Partnership agreement. The new agreement will expand to new pharmaceutical products. Following the finalization of the MRA, the extended scope would include active pharmaceutical ingredients (APIs), biologics, vaccines and immunologicals.

MRAs promote trade in goods between the European Union and third countries and facilitate market access. They are bilateral agreements, and aim to benefit industry by providing easier access to conformity assessment (For example: testing or certifications).

This is a major success towards achieving common goals in the field of good manufacturing practices by employing standard methods. Substantial benefits will be seen in pharmaceutical industry for which Japan is one of the key markets.

Both the parties are expected to complete all formal procedures in order to allow the entry into force.



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