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.