New MRA between Europe and Japan

In July 2018, the European Union (EU) and Japan have agreed to extend the scope of their mutual recognition agreement (MRA) to cover a wider range of medicines for which each other’s inspections of manufacturing sites will be recognized. The full scope of the EU–Japan MRA now covers chemical pharmaceuticals, homeopathic medicinal products, vitamins, minerals, and herbal medicines ; but also certain biological pharmaceuticals including immunologicals and vaccines.

The scope expansion means that Japan has evaluated and will recognize as equivalent all EU competent authorities for human medicines inspection.

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