Tuesday, 14 February 2012    PDF Print E-mail
European Medicines Agency and European Commission extend confidentiality arrangement with Japan
European Medicines Agency (EMA)The European Medicines Agency and the European Commission have extended their confidentiality arrangement with the Japanese medicines regulatory authorities for a year. The extended arrangements allows the Agency to continue to exchange 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 2013.

The original confidentiality arrangement, established in 2007, has been extended after all parties found it to be a useful tool in regulatory cooperation. It allows exchange of:

  • 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.

As part of these arrangements, Japan has also seconded a representative to the European Medicines Agency's offices in London since late 2009.