EU, JAPAN TO SHARE DRUG SAFETY INFORMATION

The European Union (EU) and Japan will now be able to exchange confidential information about the safety of authorized and investigational medicines. The European Commission and the European Medicines Agency (EMEA) entered into a confidentiality agreement with the Japanese Ministry of Health, Labour and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency at a bilateral meeting last week in Tokyo, the EMEA announced.

"This closer cooperation with the Japanese authorities will provide earlier access to information and thus make it easier and quicker to take action to protect public health. Our close relationship will also allow us to tackle technical barriers to trade in medicines and help prevent new barriers from occurring," Günter Verheugen, European Commission vice president responsible for enterprise and industry policy, said.

The EU and Japan have been working collaboratively for many years in the area of human medicines regulation. This has included a mutual recognition agreement on manufacturing of medicines, through the International Conference on Harmonisation and bilateral meetings.

The types of information covered under the new agreement include: advance drafts of legislation and regulatory guidance documents; scientific advice on product development given to companies to promote innovation; assessments of applications for marketing authorizations; and information about the safety of marketed medicines.

The confidentiality arrangements were established through an exchange of letters, which can be accessed at ec.europa.eu/enterprise/pharmaceuticals/pharmacos/new.htm.