Opening remarks and Ethics and regulations in Japan and in NEDO MicroDose-PJ

In Japan, clinical trials aimed at new drug/device application (NDA) are regulated by the Pharmaceutical Affairs Law, and other clinical research without such aim are regulated by \u27Ethical Guideline for Clinical Research\u27 (the Guideline) issued by the Ministry of Health, Labor and Welfare (MHLW). The MHLW issued in 2008 the guidance specific to microdose clinical trial (microdosing) and issued in 2008 guidance on non-clinical research requirements for several stages of clinical trials including microdosing, implementing ICH-M3 guideline. Our project named \u27Innovative strategies for drug development using microdosing clinical studies\u27 (NEDO MicroDose-PJ) started October 2010 under the regulation of the Guideline, using marketed drugs, without intention of NDA but with scientific research intention.In our NEDO MicroDose-PJ, Compliance of the researches has been duplicately assured by the ethics committees of the institute where research is conducted and of the University of Tokyo, the affiliation of the Project Leader. This process is most important to assure internal and external reliability of the research. This is especially important because the MHLW authorization is not required in clinical researches without intention of NDA. Additionally, through this process, safety assurance of the test drugs has been integrated by the Project Leader. Even if pharmacological effect is not expected in microdosing, safety of synthesizing process has to be assured.We now conclude that significant points for clinical research in Japan is mainly the validity of ethics committee review and safety assurance of the test drug, and in all the clinical researches in NEDO MicroDose-PJ these issues have been assured.Acknowledgement: This study is a part of \u27Innovative strategies for drug development using microdosing clinical studies\u27 (NEDO MicroDose-PJ), sponsored by the New Energy and Industrial Technology Development Organization.第31回日本臨床薬理学会年