Drug Evaluation Committee Joint Assembly of Drug Evaluation Committee and Regulatory Affairs Committee in 2026

Mr. Sato, Deputy Director General of the Minister's Secretariat, gave a lecture titled "Recent Trends in Pharmaceutical Administration. He indicated that the revision of the Pharmaceuticals and Medical Devices Law will strengthen corporate governance by making quality assurance officers and safety officers statutory and by allowing change orders to responsible officers. With regard to the stable supply of ethical drugs, it was proposed to legislate the establishment of a person in charge of supply system management, notification of shipment stoppages, requests for increased production, and monitoring of supply and demand to ensure a stable supply system. In addition, the committee stated its policy to promote early access to patients with rare and serious diseases by reviewing the conditional approval system and clarifying the use of RWDs. In the area of pediatric drugs, the committee indicated that development should be promoted by making development plans mandatory and extending the reexamination period. In the area of drug discovery, the importance of establishing a drug discovery ecosystem through public-private partnerships, such as the Practical Application Support Fund and support for drug discovery clusters, was stressed.

Mr. Kihira, Director of the Drug Evaluation Management Division, gave a lecture titled "Recent Topics on Drug Evaluation". He explained that the revision of the Pharmaceuticals and Medical Devices Law has resulted in a policy of strengthening the assurance of quality, efficacy, and safety of pharmaceuticals and other products, and that the statutory requirement for a Pharmaceutical Quality Assurance Manager and Safety Management Manager has been established to clarify the responsibilities of manufacturers and distributors. In terms of measures to ensure a stable supply, the committee presented initiatives such as the establishment of a person in charge of supply system management, the obligation to notify when shipments are suspended, and monitoring of the supply-demand situation. Under the conditional approval system, it was clarified that approval will be granted based on reasonable estimation of clinical efficacy, and that additional studies, etc. will be imposed as post-marketing conditions. The policy for the use of RWDs was also presented. For pediatric drugs, the system to eliminate drug loss by making development efforts mandatory and extending the reexamination period was explained. In addition, exceptional measures in case of difficulty in securing pharmacists and rapid response measures in case of supply shortage were introduced. Regarding review practices, the importance of scientific evaluation to comprehensively confirm the validity of development concept, data package, clinical trial design, evaluation items, number of cases, blinding and randomization, efficacy and safety assessment was emphasized. The importance of early consideration of flexible statistical methods based on the feasibility of clinical trials, especially for rare diseases, etc., was indicated. The use of related notifications and information sharing through PMDA Medinavi were also brought to the attention of the audience.

Mr. Nomura, Director of the Medical Device Review and Management Division, gave a presentation titled "Trends Surrounding Programmed Medical Devices (SaMD). He explained that, in principle, the risk classification is based on the active medical device class classification, and that the degree of contribution to disease and the impact of defects are important in determining the applicability of a medical device. The PMDA plans to strengthen and accelerate the SaMD consultation and review system by reorganizing the organization, organizing specialized teams, establishing new consultation categories, and introducing subscription-based consultation. In the area of SaMD using AI, issues related to evaluation and modification procedures for conventional AI and adaptive AI were discussed, and new evaluation methods and post-marketing surveillance for medical use of generated AI were also discussed. The importance of evaluation methods and post-marketing surveillance was also pointed out. In addition, he stated the policy to improve transparency by supporting international development, strengthening cyber security measures, and enhancing the disclosure of approval information.

Mr. Yasukawa, Director of the Drug Safety Division, gave a lecture titled "Recent Topics on Safety Measures for Drugs. He indicated that several systemic changes are planned as a result of the revision of the Pharmaceutical Affairs Law since 2026, including the revision of the periodic reporting of infectious diseases, the designation of designated abuse-prevention drugs, the elimination of the need for foreign-known serious illness reports, and the establishment of a product database. In order to strengthen quality and safety assurance, the statutory establishment of a Quality Assurance Manager and Safety Manager and the strengthening of supervisory authority over responsible officers were indicated. Regarding post-marketing surveillance, it was stated that the company is promoting a more robust operation based on necessity, organizing the criteria for investigation of all cases, and developing an evaluation method for risk minimization measures. In addition, the concept of strengthening recall and traceability by establishing a product database linked to product codes, as well as measures to deal with concomitant medications and nitrosamines, was presented. In addition, he emphasized the importance of education and system development to deal with delays in reporting adverse drug reactions, and stated that it is essential for companies to reconstruct their safety management systems to ensure the effective functioning of the system after the revision of the law.

Mr. Hasegawa, Director of the Research and Development Policy Division, gave a lecture titled "Prospects for R&D Policy Work and Expectations of Companies". He indicated that strengthening Japan's drug discovery capabilities and improving the international competitiveness of clinical trials and clinical studies are important issues. While the number of clinical trials is increasing worldwide, especially in Asia, Japan's declining participation in FIH trials, increasing U.S.-completed development, and low ratio of venture-led drug discovery were pointed out as factors contributing to drug lag and loss. In light of these factors, the panelists agreed on the need to strengthen human resources, funding, and international collaboration to build a drug discovery ecosystem, to improve the FIH system, to shift to single IRBs, to promote DCT, and to develop the infrastructure to support new modalities. In addition, the committee also indicated policies for regulatory review, promotion of pediatric and rare disease drug development, and rapid provision of drugs through PMDA internationalization. In addition, he presented the institutional arrangements and issues to be addressed in the utilization of AI, data standardization, human resource development, clinical trial efficiency improvement through promotion of PPI, review of evaluation of core clinical research hospitals, promotion of whole genome analysis, regenerative medicine, and utilization of AI.

Mr. Iimura, Executive Officer of PMDA, gave a lecture titled "PMDA Operations and Expectations for Companies," in which he explained that PMDA has achieved a significant reduction in the review period and maintains the world's fastest level of review, and that according to a survey conducted in 2024, the main cause of drug lag in Japan is not review but expansion of development lag, especially for venture drugs and rare diseases. The 2024 survey showed that the main cause of Japan's drug lag is not the review process but the expansion of the development lag, especially for venture drugs and drugs for rare diseases and pediatric use. In response to this, the committee presented a policy for institutional measures, such as clarifying and accelerating the requirements for orphan drug designation, and introducing a system to confirm pediatric drug development plans. In addition, specific support measures were introduced, including the establishment of a consultation center for pediatric and orphan drugs, fee subsidies, priority review, and the promotion of a clinical trial ecosystem. In addition, he explained that the concept of not requiring Japanese nationals to participate in Phase I trials is being reorganized for overseas advanced development products in principle, and that the establishment of overseas bases and the promotion of participation in development through consultations at international academic conferences are being promoted. In addition, the quality and efficiency of examination and consultation is being improved through Early Consideration, utilization of NAMs, introduction of AI, etc., as a response to innovation.