Since 1999, Japan’s MHLW has had strict restrictions on the disclosure of Japanese drug clinical trial information to non-medical audiences. Information like the name of the investigational drug or the specific clinical trial code was not available. On January 24 this all changed. Now, the MHLW is allowing this information to be published to non-medical audiences. For example, Japanese drug sites can post information on their websites on products they want to sell, as well as information on upcoming clinical trials. The goal of this announcement is to give more Japanese patients information on what clinical trials are available to them and help clinical trial companies with patient recruitment.
The announcement also recommends that all companies register their clinical trial information on the Japan Registry of Clinical Trials (JRTC). If clinical trial information was posted before August 31 on other registries, it will automatically be posted on the JRTC. Increased transparency with clinical trials in Japan should benefit all medical players.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.pmda.go.jp/english/rs-sb-std/rs/0011.html