Japan’s Ministry of Health, Labour and Welfare (MHLW) has issued a notification confirming that information used to recruit participants for clinical trials will now not be classified as “advertising,” as long as it is limited to necessary recruitment content. In the past, this was not allowed in Japan. Effective on March 30, this policy permits inclusion of investigational product names as long as communications remain factual and focused on recruitment only.
The guidance applies to registered studies in the Japan Registry of Clinical Trials, across both pharmaceuticals and medical devices. Under this policy, sponsors may share recruitment information across digital and traditional channels, including websites, social media, print, and video platforms. Recruitment materials must align with informed consent content, clearly state their purpose, and disclose that investigational products are unapproved and do not have established safety and efficacy.
The new policy aims to help accelerate patient enrollment and clinical trials in Japan. However, responsible communication is important, and companies should caution against overstating expectations for investigational products.
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.