EU and Japan expand cooperation on regulation

The European Medical Authority (EMA) and Japan’s Ministry of Health, Labor and Welfare (MHLW) have expanded the scope of a cooperation agreement on medical regulation.

The bodies’ existing mutual recognition agreement, signed in 2004, allows inspection of many medicines and medical production sites in one jurisdiction to be accepted in the other.

The new expanded agreement will additionally cover a variety of speciality products, including sterile medicines, vaccines, immunologicals, and active pharmaceutical ingredients (APIs).

The new agreement also underscores mutual recognition of the relevant testing bodies: the Pharmaceutical and Medical Devices Agency (PMDA) for Japan, and national level testing bodies within the EU (for example the Medicines & Healthcare products Regulatory Agency in the UK).

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Published 18. July 2018 in News, News Japan