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Table 1 Regulations on clinical trial information in Japan and USA

From: Review of the registration of clinical trials in UMIN-CTR from 2 June 2005 to 1 June 2010 - focus on Japan domestic, academic clinical trials

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)

   

December 1993

Notification of protocols of post-marketing clinical trials submitted to MHWa

   

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

   

Registration of all trials except exploratory trials

April 2007

 

Registration of clinical trials with application for Health and Labour Sciences Research Grantsb

  

September 2007

  

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)

 

November 2008

   

Registration of all confirmatory clinical trials and all exploratory efficacy trials

April 2009

 

Registration of all trials conducted in Japan (required by Ethical Guidelines for Clinical Research)

  

November 2009

   

Registration of all clinical trials in patients

  1. aRequired by Shin Iyakuhin Nado no Shiyo no Seiseki Nado ni Kansuru Cyosa Jisshi Keikakusyo ni tsu i te (the notification of protocol of use results surveys on new drugs) [21]; brequired by Heisei 19 Nendo Koseirodo Kagaku Kenkyuhi Hojyokin Kobo Yoko (requirement for the application of Health and Labour Sciences Research Grants) [25]; cJoint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases (first version issued January 2005, updated November 2008 and November 2009, by IFPMA, JPMA, PhRMA, and EFPIA) [24]. EFPIA, European Federation of Pharmaceutical Industries and Associations; FDA, Food and Drug Administration; FDAAA, Food and Drug Administration Amendments Act; FDAMA, Food and Drug Administration Modernization Act; GCP, Good Clinical Practice; IDE, investigational device exemption; IFPMA, International Federation of Pharmaceutical Manufacturers & Associations; IND, Investigational New Drug application; JPMA, Japanese Pharmaceutical Manufacturers Association; MHW, Ministry of Health and Welfare; PAL, Pharmaceutical Affairs Law; PhRMA, Pharmaceutical Research and Manufacturers of America.