Topics The "Joint Meeting of the Drug Evaluation Committee and the Regulatory Affairs Committee" was held.

The venue

2021 Drug Safety Measures - Post-marketing Response for After-Corona

Kiyoto Nakai, Director, Drug Safety Division, Pharmaceuticals and Lifestyle Health Bureau, Ministry of Health, Labour and Welfare

He explained that it is necessary to take measures and systems from pre-marketing to post-marketing, that the utilization of real world data (RWD) is important, and that the number of biopharmaceuticals developed by venture companies is increasing, and that the development methods are also being enhanced to provide early access to patients, as well as adaptive design and umbrella studies. In addition, he explained that the number of biopharmaceuticals being developed by venture companies is increasing, and that the development process is also being enhanced with systems for early access to patients, adaptive design and umbrella studies. He also mentioned the promotion of the use of medical information databases such as the MID-NET (Medical Information Database) Infrastructure Development Project and the discussion of unifying electronic medical records under the HL7 FHIR, because the safety of drugs is now a matter of considering safety measures from pre-marketing to post-marketing. If there are areas that are used overseas but not used in Japan, they should be utilized in Japan immediately.

Development of Drug Evaluation Management Services and Expectations of Companies

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

He talked about three areas: infertility drugs, generic drugs, and the use of specific clinical research results in pharmaceutical applications. Regarding the use of the results of specific clinical research for pharmaceutical applications, he explained that actual pharmaceutical applications had already been filed based on the information obtained under the Clinical Research Act. He also explained that an actual pharmaceutical application has already been filed based on the information obtained under the Clinical Research Act. Regarding the response to new coronavirus infection (COVID-19), he stated that safety measures are more necessary than before as a way of approving drug applications in emergency situations, and that it is important to continue collecting data on efficacy, etc., even after presumption and approval.

Development of Medical Device Review and Management Services and Expectations of Companies

Hideto Sekino, Director, Medical Device Evaluation and Management Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare

First, regarding the medical device system, he stated that diagnostic devices are internationally competitive, while therapeutic devices are highly invasive and domestic companies have not been able to make sufficient inroads, and that risks should be shared and handled not only on the supply side but also on the review side, since risks exist not only on the supply side but also on the review side. Next, he mentioned that there is also a conditional approval system for medical devices, and that although it is being addressed with foresight through such means as the Identification of Intended Change of Authorization Procedure (IDATEN), it is not yet being effectively utilized. He also explained that medical devices, regenerative medical products, and in vitro diagnostic products are also compliant with the revised Pharmaceutical Affairs Law, and that evaluation methods other than clinical results, including post-marketing, are being considered and utilized in the world of quality management systems (QMS).

Development of R&D promotion and expectations for companies

Junya Kasamatsu, Director, Research and Development Promotion Division, Medical Affairs Bureau, Ministry of Health, Labour and Welfare

Looking ahead to the year 2040, he explained the realization of a society in which everyone can be active and healthy for a longer period of time, as well as the current status and challenges of the pharmaceutical industry. Although Japan is one of the few bases for global drug development, the scale of Japanese companies is small and the cost of drug development is rising, so there is an urgent need to change the structure that relies on long-term listed drugs for profit, In the generic drug market, there are many companies with a small scale of operation, and it is an issue to strengthen their business structure. In addition, he gave a detailed explanation of the MHLW's initiatives for drug projects in the Health and Medical Care Strategy, innovative drug development, and the Clinical Innovation Network (CIN), including past initiatives and future measures.

Development of PMDA operations and expectations for companies

Mr. Noriatsu Kono, Director, Organization and Operation Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

With regard to PMDA's recent initiatives, he reported on the comparison of review periods for new active ingredients among regions and countries, efforts regarding COVID-19 measures, receipt of reports and investigation of suspected COVID-19 vaccine adverse reactions, proposed measures such as revision of package inserts, and the number of cases handled for various consultations. He also explained the main initiatives of the FY2022 plan in the areas of review-related operations, safety measures, regulatory science promotion, international affairs, operational efficiency improvement, and remedy-related operations. In addition, the status of the response to COVID-19 vaccine, new measures related to pharmaceutical GMP, consideration for future safety measures, RWD and digital transformation (DX) initiatives, and programmed medical devices were shared.