Date | Japan | USA | Industrial positionc | |
---|---|---|---|---|
 | Clinical trials regulated by PAL and GCP | Other clinical trials | ||
October 1979 | Notification of protocols of clinical trials for new drug application submitted to MHW (required by PAL) | Â | Â | Â |
December 1993 | Notification of protocols of post-marketing clinical trials submitted to MHWa | Â | Â | Â |
November 1997 |  |  | Registration of all trials that test effectiveness for 'serious or life-threatening’ conditions submitted to the FDA under INDs (required by FDAMA 113) |  |
January 2005 | Â | Â | Â | Registration of all trials except exploratory trials |
April 2007 | Â | Registration of clinical trials with application for Health and Labour Sciences Research Grantsb | Â | Â |
September 2007 | Â | Â | Registration of interventional studies of drugs, biologics, and devices (whether or not approved for marketing); phase 2 through 4; at least one US site or IND or IDE (required by FDAAA 801) | Â |
November 2008 | Â | Â | Â | Registration of all confirmatory clinical trials and all exploratory efficacy trials |
April 2009 | Â | Registration of all trials conducted in Japan (required by Ethical Guidelines for Clinical Research) | Â | Â |
November 2009 | Â | Â | Â | Registration of all clinical trials in patients |