Topics The "Joint General Meeting of the Drug Evaluation Committee and the Pharmaceutical Affairs Committee in 2023" was held.

Recent Trends in Pharmaceutical Administration

Dr. Fumi Yamamoto, Deputy Director-General (Pharmaceuticals), Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare

The meeting began with an explanation of the environment surrounding us, including the declining birthrate, the "super" aging of the population, globalization, and advances in science and technology. He reviewed the three years under the Corona disaster and talked about a very wide range of issues, including stable supply and quality issues, changes in the environment surrounding the pharmaceutical industry, the direction of medical DX, cooperation with overseas regulatory authorities, drug resistance (AMR), innovation, and existing issues such as crisis management.

He concluded by reflecting on how the medical field and social activities have evolved under the Corona Disaster, and what we should aim for in the future. He also stressed that we should take advantage of what we have realized and experienced in the past three years or so, while reaffirming the importance of pharmaceuticals and medical technology, to evolve our activities in the future. He concluded by saying that we should take advantage of what we have learned and experienced over the past three-plus years to the fullest extent and use this opportunity to evolve our activities in the future.

Recent topics concerning approval review of pharmaceuticals, clinical research and clinical trials, etc.

Mr. Yasunori Yoshida, Director, Drug Evaluation and Management Division, Pharmaceuticals and Lifestyle Health Bureau, Ministry of Health, Labour and Welfare

He talked about recent activities related to approval review and the response to new coronavirus infection (COVID-19). After an introduction of the recent approval status, he explained about the mechanism to utilize information obtained from clinical studies for regulatory applications, points to keep in mind when obtaining explanations and consent by electromagnetic methods in clinical trials and post-marketing clinical studies, online application and notification, oral abortion pills and emergency contraceptive pills, and the activities of the expert panel. The meeting also included an explanation of the COVID-19, which has been used to date. After discussing the status of approval and development of therapeutic agents and vaccines for COVID-19 to date, he explained the handling of this infection after it is transferred to category 5 on May 8, 2023.

Medical device review and management services and expectations of companies

Mr. Tomonori Nakayama, Director, Medical Devices Evaluation and Management Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare

After an introduction of the establishment of the Pioneering Medical Device Designation System as a system aiming for early practical application of innovative medical devices in Japan ahead of the rest of the world, an explanation of the items that have been designated so far was given.

Next, he explained about the IDATEN (Innovative Device Approval Approval Technology Network), which is an approval review system that enables continuous improvement of medical devices that are expected to be improved, how to proceed with studies on the early introduction of medical devices with high medical needs, and the project to promote the acquisition of international standards for innovative medical devices.

Trends in surveillance and guidance services and expectations of companies

Mr. Daisaku Sato, Director, Monitoring, Guidance and Narcotics Control Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare

Starting with a slide presentation on "Always Governance, Always Compliance," the presentation included a trend in the content of violations in recent administrative disciplinary cases, an analysis of the current situation regarding issues characteristic of business models, and a specific explanation of the issues in GMP/GQP that were identified through these cases.

He also reconfirmed whether each company's legal compliance system is being properly implemented and whether a corporate culture is being fostered. He then explained the measures that have been taken to date to ensure quality in light of the quality incidents, the strengthening of regulations, and the outlook for future regulatory tightening.

Recent activities of PMDA
- Challenges based on regulatory science

Mr. Shinobu Utsu, Director, Pharmaceuticals and Medical Devices Agency, Japan (in charge of technical supervision, safety, etc.)

First, he explained the promotion of regulatory science at PMDA. Next, as responses to IT technology, he explained the progress and current status of online application and notification, utilization of real world data (RWD)/real world evidence (RWE) for approval review, and online clinical trials. In addition, as status of issues and responses to them, he explained the current status of the use of electronic data for applications at PMDA, confirmation review based on the Cartagena Act, and patient involvement efforts (collection and provision of safety information between PMDA and patient groups).