The European Medicines Agency (EMA) reports that its levels of interaction and cooperation with the medicines regulatory authorities in Japan have increased over the past three years.
Since November 2009, when the Japanese authorities seconded their first liaison official to the EMA on a pilot basis, there has been an increase in information exchange and interaction in areas of mutual interest, with Japanese and European representatives attending conferences and meetings in each other’s territories, the Agency reports.
Particular progress has been achieved in the area of orphan drugs. A visiting expert from Japan worked at EMA’s Orphan Medicines Section between September 2010 and March 2011, which provided a Japanese perspective to scientific committees as well as to EMA staff members. In addition, there have been several visits to EMA by Japanese officials, and European Union (EU) officials have participated in a number of high-level conferences in Japan.
There has also been improved cooperation in the area of rare diseases, while in paediatrics, agreement has been reached for the Agency’s Japanese colleagues to participate as observers in the EMA/US Food and Drug Administration (FDA) cluster on paediatric medicines.
Other areas where there has been increased interaction over the period include advanced therapies, pharmacogenomics and biomarkers, nanomedicines and inspections, the Agency notes.
The presence at EMA 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, the report concludes.
The Agency points out that its interactions with the Japanese Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) fall under the confidentiality arrangements between the EU and Japan which were established for an initial five-year period in 2007 and then extended for a further year in the early part of 2012. These arrangements allow the exchange of information as part of regulatory and scientific processes, both before and after a medicine has been approved.
EMA has also now published the pilot terms of reference for cooperation between the EU and Japan on orphan medicines. These set out the objective of establishing an operational framework focused on a series of activities, i.e., the creation of greater awareness of mutual process for orphan medicine designations submission, and the development of systems of exchange regarding: – the outcomes of orphan drug designations in each Agency and Ministry; – regulatory and licensing stages concerning orphan drugs; and – pharmacovigilance post-licensing activities associated with orphan medicines.
The initiative also seeks to develop a collaboration mechanism regarding small to medium-size enterprises (SMEs) – within the range of confidentiality arrangements.
