Japan discusses micro-dosing study

At the third meeting of the Japanese Health, Labor and Welfare Ministry's Study Committee on Clinical Trials, aimed at faster provision of new safe and effective drugs, the panel discussed the introduction of a micro-dosing study to identify the pharmacological action in humans before conducting Phase I clinical evaluations as one measure to promote the early approval of new drugs.

In Japan, there have been no guidelines for implementing micro-dosing studies for the filing of a New Drug Application and no reports on having conducted a micro-dosing study aiming at a submission in Japan so far.

In response to a recommendation made by the Council for Science and Technology Policy, presided over by Japan's Prime Minister Shinzo Abe, within the Cabinet Office, the panel has decided on studying the possibility of introducing the micro-dosing study.