In a meeting on May 8, Mr. Katsufumi Jo of Japan’s Upper House Health Committee within the Ministry of Health, Labour and Welfare (MHLW) described the scope of Japan’s newly widened conditional approval scheme for drugs. He said that the expanded scheme is intended to expand access to new therapies, especially for deadly diseases with no alternative therapy.
The new system will now allow conditional approval based on Phase II (PII) data even for drugs with patient availability to carry out Phase III (PIII) trials. This is a definite departure from the original plan, which was being used only for ultra-rare diseases where PIII trials were not possible. For this new conditional approval scheme, confirmatory PIII-equivalent post-approval studies will be needed, with the option to withdraw approval if efficacy or safety cannot be proven.
Mr. Jo referred to American or European startups’ cancer medications approved abroad but not sold in Japan as examples of medicines that could be helped by the new conditional path. He pointed out that the system was designed to tackle Japan’s continued drug loss issue and speed access to new treatments.
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.