EMEA and Japanese agency agree to exchange confidential information

The European Medicines Agency (EMEA) and its Japanese counterpart have agreed to exchange confidential information on medicines.

The agreement, signed on the one hand by the Commission and the EMEA and on the other by the Japanese ministry of health, labour and welfare (MHLW) and the Japanese pharmaceuticals and medical devices agency (PMDA), follows a similar agreement signed in 2005 between the EMEA and the US FDA. The agreement with Japan is said to be "more or less identical" to that with the US, except that it covers only medicines for human use.

Following the signing of the agreement, at a bilateral meeting on Friday in Tokyo, the European Union and Japan can now exchange confidential information on issues such as the safety of marketed medicines and products being developed or considered for authorisation. The agreement is couched in fairly general terms, but an implementation plan will be set up during the year, according to EMEA.

Japan and the European Union had previously concluded a mutual recognition agreement on medicines manufacture, through the International Conference on Harmonisation (ICH) and bilateral meetings.

The new agreement will allow them to exchange information during the regulatory and scientific process, both before and after a medicine is approved. The information concerns legislative drafts, scientific opinions, marketing authorisation application assessments and product safety.

'We have been working closely with our Japanese counterparts for many years and I see these new confidentiality arrangements as an important step forward,' said EMEA executive director Thomas Loenngren.