Topics Held "2024 Asia-Pacific Economic Cooperation Conference Regulatory Harmonization Steering Committee (APEC RHSC)
The Regulatory Harmonization Steering Committee (RHSC) of the Asia-Pacific Economic Cooperation Conference (APEC) will be held in Singapore from July 18 to 19, 2024. The RHSC is a committee that coordinates the development of voluntary coordination and open regional cooperation to promote pharmaceutical business in the APEC region, bringing together representatives of industry and academia, in addition to government agencies from the 21 member economies of the Pacific. It is a committee that coordinates to promote voluntary coordination and open regional cooperation. The committee promotes regulatory harmonization, particularly with regard to pharmaceutical and medical device regulations, by providing training and capacity building so that they can be applied in the same way across regions without having to change laws and regulations (regulatory convergence).
Group photo
Introduction
The RHSC is chaired by Japan and the U.S., with Naoyuki Yasuda, Executive Director of the Pharmaceuticals and Medical Devices Agency (PMDA), and Michelle Limoli of the U.S. Food and Drug Administration (FDA) serving as co-chairs. APEC itself is a government-to-government meeting, so the RHSC key members However, the Pharmaceutical Manufacturers Association, along with the Pharmaceutical Research and Manufacturers of America (PhRMA), has long been a key member of the RHSC, representing research-based pharmaceutical companies, and continues to participate in RHSC meetings.
Content of the Meeting
The RHSC's vision for 2030 (RHSC 2030 Vision) is to promote regulatory convergence within APEC. Medical products can be delivered to patients only after they have been reviewed and approved by health authorities, and it is hoped that through the activities of the RHSC, the operation of pharmaceutical regulations among health authorities and the criteria for review based on these regulations will be standardized, so that new drugs and other products can be provided to the APEC region with little difference from year to year.
The RHSC has established several Priority Working Areas (PWAs), which are considered important for the development and review of medical products, and one of the APEC health authorities leads each PWA. In recent years, the focus has shifted to activities aimed at improving and standardizing the level of review by health authorities in APEC by holding workshops to disseminate the content of PWAs. At this meeting, the health authorities leading the PWAs reported on their updated activity roadmap proposals and active plans and achievements in holding workshops. The Pharmaceutical Manufacturers Association of Japan (PMAJ) has been involved in the Good Registration Management (GRM), a PWA jointly organized by the Taiwanese FDA and PMDA, since its inception by formulating guidelines and training programs and dispatching lecturers to workshops. Therefore, in the report on GRM activities from the Taiwan FDA, the RHSC reiterated the contribution of the Pharmaceutical Manufacturers Association of Japan (PMAJ). In response to requests from health authorities, the RHSC has dispatched lecturers not only to GRM but also to several PWA workshops.
Through its participation in this meeting, the RHSC was able to confirm that its activities toward the RHSC 2030 vision are steadily advancing through multiple PWA workshops. New PWAs were also proposed, and it was expected that the scope of the RHSC's activities will continue to expand.
Scene of the meeting
Concluding Remarks
The RHSC will continue its activities under the APEC Sub-Committee on Standards and Conformance (SCSC) from 2024, and this was the first meeting under the new framework. Korea will host and host APEC in 2025. The Pharmaceutical Manufacturers Association of Japan (PMAJ) will continue to cooperate in the promotion of regulatory harmonization activities in the APEC region through participation in the RHSC and dispatch of lecturers to PWA activities.
APAC RA-EWG leader Shinji Hatakeyama (left) participated from the Pharmaceutical Manufacturers Association of Japan.
Sachiko Nakagawa, Executive Director of the Pharmaceutical Manufacturers Association of Japan (center) and Mariko Kato, Director of the International Regulatory Coordination Department (back right)
(APAC RA-EWG Leader: Shinji Hatakeyama, International Regulatory Coordination Division Director: Mariko Kato )