Brussels, 05/02/2007 (Agence Europe) - On Monday 5 February, the European Commission announced the signing of confidentiality agreements with Japan in the pharmaceutical domain. These agreements are expected to facilitate cooperation between the authorities (AMM) in charge of authorising the marketing of medicines in Europe and Japan.
The European Commission's Directorate Enterprise and Industry, the European Medicines Agency (EMA), the Japanese Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) concluded confidentiality agreements in the area of regulation of medicines for human use during a bilateral meeting on Friday 2 February 2007 in Tokyo. For many years the EU and Japan have been collaborating in the area of medicines for human use. An agreement of mutual recognition on manufacturing medicines was concluded in the context of the International Cooperation on Harmonisation conference and in other bilateral meetings. The new confidentiality agreements are based on the cooperation that has existed for several years, and which will allow for exchanges of views between the parties in relation to their regulatory and scientific processes before and after medicines are approved. Information in this context is as follows: preliminary draft legislation and/or regulatory orientation documents; scientific opinions given to companies on updating products to encourage innovation; assessments of marketing authorisation requests; information about the safety of medicines on the market in an effort to better protect public health. Similar cooperation already exists between the EMA and US FDA. (oj)