PMDA's efforts for international collaboration and activities of Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs

On August 20, 2021, the 3rd Academia Clinical Development Seminar was held online, inviting Dr. Akiko Ogata, Division Director of Division of Training Center Management/ Division of Asia I, Office of International Programs, Pharmaceuticals and Medical Devices Agency.

Dr. Ogata has been involved in drug review and safety measures, as well as in the planning and management of seminars for regulatory officials in Asian countries. In this seminar, based on her extensive experience, she gave a lecture titled "PMDA's efforts for international collaboration and activities of Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs".

Role of the Pharmaceuticals and Medical Devices Agency (PMDA)

First, about role of the PMDA, she explained that the PMDA is responsible for providing important evidence for the Ministry of Health, Labour and Welfare in exercising its authority over the administration of medical devices, etc.

It also conducts operations related to ensuring the quality, efficacy and safety of pharmaceuticals and medical devices, focusing on approval review, safety measures and health damage relief.

Establishing an environment for the approval of innovative medical devices in the world

Next, she explained about the review system for medical devices at PMDA. The Medical Device Unit consists of six offices, and the Office of Software as a Medical Device was newly established in April this year, as the number of AI medical devices is expected to increase further in the future.

Regarding the review period for medical devices, she said that the target review period is set at 10 months for new medical device priority items and 14 months for regular items.

In addition, in order to shorten the review period, the law was amended in November 2019 and came into effect in September 2020, and systems for expedited approval were established, such as (1) Sakigake designation scheme, (2) a system for early approval of medical devices for specific uses (pediatric medical devices, etc.), (3) a conditional early authorization system, and (4) an approval system based on the characteristics of medical devices (IDATEN/PACMP).

As a result of these various efforts, it seems the review lag has been almost completely eliminated.

International Strategy in PMDA

Next, regarding the international strategy, she said that the "PMDA International Strategy 2015" was formulated in 2015, and international activities to be undertaken in the mid-term plan until FY2023 were defined.

Specifically, the activities include (1) demonstration of international leadership, (2) strengthening of bilateral relationships, (3) enhancement of the Asian Training Center, and (4) proactive communication of activities to the world, etc., and these active efforts are being made.

In Asia, the "Basic Policy of the Asian Health and Wellbeing Initiative" was decided in 2016 to promote regulatory harmonization in order to contribute to the elimination of the drug lag between Japan and Asia, and based on this policy, the Grand Design for Asian Pharmaceutical and Medical Device and Regulatory Harmonization was formulated as a concrete initiative.

The main measures include (1) strengthening the system by forming platforms such as the Asian Network Meeting, collaborating with industry initiatives, and assigning a dedicated person in charge in each Asian country, (2) improving the clinical trial system by supporting the development of clinical trial sites, and (3) promoting regulatory harmonization such as international standardization and promotion of Reliance. She said that international regulatory harmonization is important for rapid overseas expansion.

Activities of the Asia Pharmaceuticals and Medical Devices Training Center (PMDA-ATC)

Next, she explained the activities of the PMDA-ATC, which was established in 2016.

Through the training provided by the PMDA-ATC, the program aims to have those who related to authority body in Asian countries 　deepen the understanding of the Japanese system and the importance of regulatory harmonization, thereby laying the foundation for future regulatory harmonization in the Asian region and building confidence in Japan.

Multilateral Cooperation

Regarding multilateral cooperation, she explained about international activities through multilateral meetings such as ICMRA (International Coalition of Medicines Regulatory Authorities), ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), APEC-LSIF-RHSC (Asia-Pacific Economic Cooperation Life Sciences Innovation Forum Regulatory Harmonization Steering Committee), and IMDRF (International Medical Device Regulators Forum).

Cooperation with Asian Countries

Finally, the importance of Reliance in working with Asian countries and bilateral exchanges was explained.

According to the WHO definition, Reliance is defined as “The act whereby the National Regulatory Authority(NRA) in one jurisdiction may take into account and give significant weight to assessments performed by another NRA or trusted institution.”

In the APEC region, the number of members of ICH and PIC/S has been increasing due to the penetration of Reliance activities, and the use of evaluation results from each country's approval review is expected to improve the efficiency of review and promote the international harmonization of GMP.

In addition, she said that PMDA is conducting bilateral exchanges between Japan and other Asian countries to deepen mutual understanding among pharmaceutical officials and to form the basis for cooperation in pharmaceutical and medical device regulation and development.

In this seminar, Dr. Ogata gave a very useful and interesting lecture on the PMDA's efforts as well as on international relations, especially in Asia, and the seminar was a great success with many participants. The next Academia Clinical Development Seminar is scheduled to be held in November.

We look forward to seeing you at the next meeting.