Topics The Joint Meeting of the Drug Evaluation Committee and the Pharmaceutical Affairs Committee 2020 was held.

He thanked us for the opportunity to meet and talk directly with him while taking the hybrid response, despite his appointment as Deputy Director General of the Minister's Secretariat as of January 1, 2020, which he had not had a chance to do so directly due to the recent spread of the novel coronavirus infection. He then talked about the current environment surrounding Japan, as well as his thoughts on the revision of the Pharmaceutical Affairs Law and the status of its implementation. He then talked about the current environment surrounding Japan, his thoughts on the revision of the Pharmaceutical Affairs Law, and the current status of its enforcement.

He then talked about the current environment surrounding the pharmaceutical industry and the current status of the approval review process. He mentioned that the structure of diseases in Japan is such that cerebrovascular diseases are decreasing and cancer is increasing, and that as a new drug development trend, clinical trials for anti-cancer drugs are increasing dramatically. In addition, he explained about recent developments and attempts to utilize real world data (RWD) and the recent revision of the Pharmaceutical Affairs Law. In addition, he explained the "Treatment of Approval Examination of Pharmaceuticals for New-type Coronavirus Infections" and said that the Ministry of Health, Labour and Welfare (MHLW) would make every effort in cooperation with pharmaceutical companies to achieve early commercialization of a vaccine against new-type coronavirus infection.

First of all, he thanked the pharmaceutical industry for its great cooperation in the measures against the new type of coronavirus infection, and then he explained the current priority initiatives of the R&D Promotion Division in the Health and Medical Care Strategy, including the establishment of the Clinical Innovation Network (CIN), promotion of pediatric drug development, and data health reform. He also talked about the current R&D Promotion Division's priority initiatives in the Health and Medical Care Strategy, including the establishment of the Clinical Innovation Network (CIN), development and promotion of pediatric drugs, data health reform, and ICT in healthcare. The MHLW is working with the Ministry of Education, Culture, Sports, Science and Technology (MEXT) and the Ministry of Economy, Trade and Industry (METI) to promote the practical application of pharmaceuticals that meet the needs of the medical community, and the R&D Promotion Division is promoting measures to promote practical application through the Research Project to Promote Basic Drug Discovery and the Research Project to Promote Clinical Research and Trials.

As a topic of safety measures for pharmaceuticals, he talked about the trend of digitization of package inserts due to the revision of the Pharmaceutical Affairs Law. The attached document should no longer be packaged with the product, and the user should be able to view the attached document and related documents such as drug risk management plan electronically by using an application from the code on the outer package. He also expressed high expectations for the promotion of pharmaceutical companies' use of MID-NET (Medical Information Database Infrastructure Improvement Project). He expressed his view that the time has come to clarify what is required as evidence before and after marketing at the review stage and to respond to it, and that it is time to consider development with a view to post-marketing drug development, taking into consideration the legalization of the Pioneer Review Designation System and the Conditional Early Approval System, and to start discussions for this purpose.

Recent annual trends in surveillance and guidance operations show that the number of guidance cases has been increasing in recent years, especially recalls due to manufacturing methods that differ from those in the approval documents. Among them, he explained that the industry needs to pay attention to the trend of recalls due to illegal manufacturing of products caused by problems with active pharmaceutical ingredients. In the area of advertising regulations, the committee reiterated its request for the enhancement of internal systems to comply with the guidelines regarding sales information provision activities for ethical drugs. In addition, he explained the surcharge system for advertising violations that has been enacted into law, and discussed import monitoring, GMP (Good Manufacturing Practice), and the maintenance of legal compliance systems.

As a comprehensive risk management based on the Safety Triangle as the basic structure of the fourth mid-term plan of the Pharmaceuticals and Medical Devices Agency (PMDA), we will improve our operations by promoting regulatory science, promote internationalization, and establish a governance and compliance system based on the role of the organization and its social position. As the only public organization in the world that performs these three roles in an integrated manner, we will contribute to the improvement of medical standards by delivering safer and more effective products to medical facilities earlier, based on regulatory science, as well as actively contribute to the extension of healthy life expectancy of the Japanese people by 2040. The PMDA will also play an active role in extending the healthy life expectancy of the Japanese people by the year 2040.