The Headquarters for Healthcare Policy points out that Japan's clinical trial environment needs improvement

To discuss matters that should be included in the Medical Field R&D Promotion Plan and Japan Agency for Medical Research and Development (AMED)'s third medium- to long-term plan to accelerate R&D of pharmaceutical products, the Drug Development Council of the Headquarters for Healthcare Policy held a meeting. A wide variety of discussions were held, especially on Japan's poor performance in clinical trials compared to other countries, which has become a "valley of death" in the process of basic research to commercialization, and on the fact that Japan is not selected for international joint clinical trials, which is said to be one of the reasons for the drug lag/loss. Specific suggestions were put forward on how to improve this.

Professor Toshio Miyata of Tohoku University said, "With the establishment of the Japan Consortium of Clinical Research Hospitals and AMED, we have conducted small-molecule exploratory level research and accumulated know-how and other empirical values. The phase 3 level should be further advanced in the future. The Pharmaceuticals and Medical Devices Agency (PMDA)'s response is also different from that of the phase 2 level, and the hurdles are higher in many ways. Especially for rare illnesses, etc., it is difficult for companies to take the initiative; therefore, a new mechanism is needed."

Hiroaki Ueno, President of the Japan Pharmaceutical Manufacturers Association, pointed out, "The creation of an environment for clinical trials for new modalities will lead to Japan's strength. First-in-human (FIH) facilities are needed, especially for new modalities, etc. It is necessary to go deep down to the point of determining what facilities and systems are needed for each modality of gene therapy, nucleic acid therapeutics, and cell therapy."

In addition, various opinions were expressed by each committee member regarding the provision of one-stop services for overseas companies and emerging biopharma (EBP), overseas PR for Japan's clinical trial environment, organization of related laws and regulations such as the Pharmaceutical and Medical Device Act and the Clinical Trial Act, efforts to develop human resources to conduct clinical trials, and digital transformation of the clinical trial environment, etc. The Cabinet Office and related ministries and agencies will consider specific measures, based in part on this discussion.