EMA's collaboration with the US FDA tends to receive the most media attention, but the European regulator has also been increasingly interacting with its counterparts in Japan at the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceutical and Medical Devices Agency (PMDA).
Growing collaboration with Japan boosts drug applications and reviewsThe Japanese regulators have been very committed to improving their relationship with both EMA and FDA following criticism from the pharmaceutical industry regarding a perceived time lag in Japan in the approval of new drugs and medical devices compared with the EU and the US (3). These perceptions have led some manufacturers to delay their submissions to Japanese regulators. For example, applications for an estimated 69 new active substances were submitted between 2002 and 2011 to regulators in the US, EU and Japan. Approximately 77% of these were submitted to PMDA more than one year after submission to EMA or FDA (4). Japanese regulators seem to have realised that it is imperative they improve their international standing.
Confidentiality agreements between EMA and its Japanese partners have been in place since 2007, and were recently extended for a further year in July 2012. Such agreements facilitate the exchange of confidential information between the agencies as part of their regulatory and scientific processes. Shared information may include advance drafts of legislation and regulatory guidance documents, as well as non-public information related to ensuring the quality, safety and efficacy of medicinal products. EMA personnel also meet regularly with their counterparts from the MHLW and the PMDA.
In November 2009, Japan sent a Liaison Official to EMA's offices as a pilot exercise. In July 2012, a report was published by EMA concerning the progress in collaboration that had been made since the appointment (5). The Japanese representative meets weekly with EMA's International Liaison Officer to discuss ongoing activities and areas that need to be addressed. Interactions facilitated by Japan's representative have covered a number of different specialist areas, including advanced therapy medicinal products, pharmacogenomics and biomarkers, paediatrics, orphan drugs and nanomedicines (5–7).
It was concluded that the placement of the Japanese representative at the EMA has been extremely beneficial in terms of education, proactively raising awareness of possibilities for collaboration and the general timeliness of inter-agency communication. Although the EMA has not yet appointed a Liaison Officer to PMDA or MHLW, such a move seems likely in the future.
Cooperation between Europe and Japan has been particularly beneficial in the area of advanced therapy medicinal products. Staff from PDMA attended EMA's Committee on Advanced Therapies (CAT) Workshop on Stem-cell based Therapies, followed by the CAT plenary, in May 2010, and provided input from their perspective on a draft reflection paper on stem cell-based medicinal products. Since then, PDMA has proposed additional collaboration in the area of cell therapy (5). Through a joint EU–FDA–PMDA regulatory mechanism, PMDA has also participated in scientific advice regarding renal toxicity biomarkers.
Rare diseases have also seen much interest from both regulators. MHLW sent an external expert to EMA as part of a visiting expert programme between September 2010 and March 2011 (5). The representative was embedded in the Orphan Medicines Section of EMA and provided information to EMA's Scientific Committees and staff members. This initiative has led to better information exchange between the agencies on the outcomes of orphan medicine designations in each region (7). It has also focused attention on practical measures, such as the provision of information from the Japanese regulator in English. Regular telephone conferences are now held, usually on a quarterly basis, to discuss orphan drug topics.