Deal cleared for closer ties on medicines safety between Japan and EU

Henceforth, Japan and the European Union will be able to exchange confidential information about the authorization and safety of medicines. Confidentiality arrangements have been agreed between the European Commission and the European Medicines Agency (EMEA) on the one side and the Japanese Ministry of Health, Labor and Welfare (MHLW) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) on the other, at a bilateral meeting in Tokyo.

Under the terms of the accord, the partners will be able to exchange confidential information, for instance on safety issues with marketed medicines and products being developed or considered for authorization.

European Commission Vice President Gunter Verheugen, who is responsible for enterprise and industry policy, said: "this closer cooperation with the Japanese authorities will provide earlier access to information, and thus make it easier and quicker to take action to protect public health. Our close relationship will also allow us to tackle technical barriers to trade in medicines and help prevent new barriers occurring."