On March 18, the Japanese MHLW announced six goals to strengthen their clinical trial capabilities. First, Japan wants to build a more advanced, first-class clinical trial regime to enhance and promote local clinical trials. Second, the MHLW hopes to build a better infrastructure to facilitate decentralized clinical trials, and real-world data. Third, to reduce costs, the MHLW is proposing the use of centralized Institutional Review Boards and more use of AI and machine learning. Fourth, the costs of clinical trials should adopt the Fair Market Value concept of clinical trials that is prevalent in the West. Fifth, the MHLW wants to develop more research experts and doctors and provide appropriate incentives for them to help hospitals/clinics to be more interested in doing clinical trials. Finally, the MHLW wants to centralize information on clinical trials so more patients and the public will be aware of such activities. The MHLW plans to have more meetings on these clinical trial topics over the next few months and release their report in May/June.
In addition, on March 21, the Japanese PMDA outlined a notification for the development of pediatric drugs. In this notification, the PMDA said that they will provide guidance via consultation services to drug manufacturers who are developing pediatric drugs including feedback on the maker’s pediatric indications, development plan, and required clinical trials. The PMDA also recommends that Japanese companies participate in more pediatric global clinical studies initiated in the West. In short, Japan has a strong interest in developing more drugs for their children.
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.