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 5-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, Labour 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 EU and Japanese authorities.
It provides for the international exchanges in areas such as the following:
- advance drafts of legislation and regulatory guidance documents;
- scientific advice on medicine development;
- assessments of applications for marketing authorisations;
- information about the safety of marketed medicines.
Since late 2009, in the context of this arrangement, PMDA has assigned a liaison official to work in the European Medicines Agency’s offices in London.