In order to create a more integrated system for Japanâ€™s medical regulatory process, the Ministry of Health, Labor and Welfare signed a bill at the end of 2002 establishing a new independent administrative institution. The new institution will unify the Organization for Pharmaceutical Safety and Research (OPSR, also known as Kiko), the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) that is under the auspices of the National Institute of Health Sciences, and the Japan Association for the Advancement of Medical Equipment (JAAME). The new institution, tentatively named the Comprehensive Organization for Medicines and Medical Equipments, will be established in April 2004.
The primary mission for the new organization will be to ensure the quality, safety, and efficacy of medicines and medical equipments in Japan. The organization will also be responsible for improving national health by addressing health problems caused by adverse drug reactions (ADRs) and infections from biological products. The new organization will also promote development in pharmaceutical technology through product reviews and fundamental research.
It is expected that the majority of funding for the new institution will come from contributions from pharmaceutical companies. This has created concern due to the possible influence of the pharmaceutical industry upon the independent institution. In order to address issues of neutrality, transparency, and impartiality, a resolution for fairness was adopted for the new organization in order ensure the administrative institutionâ€™s accountability to the public while still meeting the expectations of the pharmaceutical industry.