EMA and European Commission renew confidentiality arrangement with Japan

The European Medicines Agency and the European Commission’s Directorate General for Health and Consumers have renewed their confidentiality arrangement with the Japanese medicines regulatory authorities for a further five-year period.

The renewal of this arrangement allows the Agency to continue the exchange of confidential information on the regulation of human medicines with Japan's Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) until February 2018, with the possibility of further extensions for five-year periods.

The renewal builds on the success of the original 2007 confidentiality arrangement as a tool for enhanced regulatory collaboration between the European Union and Japanese authorities.