In Japan, recruiting patients for clinical trials is not an easy process. Advertising regulations for investigational trials, under Article 68 of the PMD Act, are restrictive and follow the same rules as advertising regulations for already approved drugs. This has made it challenging to find appropriate patients for some clinical trials. This is especially true for patients who cannot access drug companies’ websites easily, which is the only place clinical trial information is available today. For such patients, it may be difficult to know what clinical trials are available. Thus, in late July, Japan’s Health Sciences Council subcommittee on drugs and devices developed a plan that was sent to the MHLW to facilitate easier information sharing on upcoming clinical trials. The plan is to get industry feedback and make this an official notification by the end of March 2026.
Under this proposed plan, drug companies and other clinical trial sponsors will now be able to disseminate clinical trial drug names, dates, and locations of trials, etc. Such additional advertising and promotion would only be allowed during the clinical trial timeframe. In addition, the proposed plan will enable sponsors to provide summaries and related materials for overseas clinical trials that have or will use the same drug. These processes would then not be considered “advertising” if it is provided to patients who are actually looking for clinical trial information. Also, various patient groups that have formed for certain diseases could also share such clinical trial information, and this would not be considered as “advertising” either.
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.