Japan’s Ministry of Health, Labour and Welfare (MHLW) has issued a Q&A document clarifying how the revised conditional approval system under the amended Pharmaceuticals and Medical Devices (PMD) Act will be implemented as of May 1, 2026.
The updated framework expands the scope of the conditional approval pathway, which was previously limited mainly to products for small patient populations where confirmatory Phase III trials were difficult to conduct. Under the revised system, drugs intended to treat serious diseases with high unmet medical need may also qualify for conditional approval even when Phase III studies are not difficult to conduct.
According to the MHLW, eligible products must demonstrate a certain level of safety based on non-confirmatory clinical studies. The ministry noted that exploratory studies are generally expected, but other forms of evidence may also be considered depending on the characteristics of the product. Examples mentioned include pharmacodynamic studies, antimicrobial activity studies, etc.
The Q&A also provides further detail on how conditional approvals may be reassessed after commercialization. If post-marketing studies fail to confirm efficacy or if the risks of a product are ultimately found to outweigh its benefits, the MHLW may withdraw the approval. However, the ministry indicated that in some cases it may instead revise the approved indication or restrict the eligible patient population as a risk management measure.
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.