European Medicines Agency sees benefits of interaction with Japanese regulators
The European Medicines Agency has increased its level of interaction and cooperation with medicines regulatory authorities in Japan over the past three years, according to the report on interactions published today.
Since November 2009, when the Japanese authorities seconded their first liaison official to the Agency, there has been an increase in information exchange and interaction on areas of mutual interest, with Japanese and European representatives attending conferences and meetings in each others' territories.
The presence of a new liaison officer from Japan continues to provide a strong basis for mutual education, awareness of opportunities for interaction and communication between the European and Japanese authorities, helping to address public-health issues and avoid duplication of work.
Particular progress has occurred in the area of orphan medicines, with a visiting expert from Japan working at the Agency between September 2010 and March 2011 and improved cooperation in the area of rare diseases. In paediatrics, Japanese colleagues will begin to observe the interactions between the Agency and the United States Food and Drug Administration (FDA). Other areas of increased interaction include advanced therapies, pharmacogenomics and biomarkers, nanomedicines and inspections.
The Agency's interaction with the Japanese Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency (PMDA) falls under the confidentiality arrangements between the European Union and Japan, established for an initial five-year period in 2007 and extended for a year earlier in 2012. The confidentiality arrangements allow exchange of information as part of regulatory and scientific processes, both before and after a medicine has been approved.
Today also sees the publication of the pilot terms of reference for the cooperation between the EU and Japan on orphan medicines. This document lays out the objectives and activities concerning medicines for rare diseases, concentrating on areas that both regions consider to be of high interest.