EU and Japan to share regulatory information

The EU and Japan have been working collaboratively for many years in the area of human medicines regulation. However, they will now be able to exchange confidential information on marketed medicines and products being developed for authorization.

The regulatory authorities believe that this exchange of information will lead to accelerated access of patients to medicines, cost savings and improved performance and safety as a result of combined expertise.

These confidentiality arrangements have been agreed between the European Commission and the European Medicines Agency (EMEA) on the one side and the Japanese Ministry of Health, Labour and Welfare (MHLW) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) on the other.

The types of information covered include advance drafts of legislation and/or regulatory guidance documents, scientific advice on product development, assessments of applications for marketing authorizations and information about the safety of marketed medicines.

“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 occurring,” said Gunter Verheugen, European Commission vice-president.