Introduction:

The Committee on Trade and investment (CTI) under the Asia Pacific Economic Cooperation (APEC) has established a large number of dialogue mechanisms with the industry, among which the Life Sciences Innovation Forum (LSIF) is the dialogue and cooperation mechanism with the medical industry. An important objective of the mechanism is to coordinate the concerted actions and policies of countries and economies in the field of pharmaceutical regulation, so as to promote the effective circulation of scientific research achievements and products of life sciences in the Asia Pacific region, so as to benefit the people in the region. Therefore, under the guidance of the mechanism, the regulatory harmonization Steering Committee (RHSC) was established to explore the establishment of Center of Excellence on regulatory science to build an open and sustainable platform for tripartite cooperation among government, enterprises and academic institutions, so as to promote the regulatory synergy ability in the field of medical products. The Center of Excellence is constructed and operated by universities, research institutions or government regulatory agencies of regional economies. It provides a variety of services such as regulatory scientific cooperation, communication and training to all economies in APEC region.

In October 2019, RHSC approved the pilot training of medical device regulatory science Center of Excellence to be held in Chengdu in December 2019. The pilot training was sponsored by Sichuan University and co-sponsored by the Research Base of Regulatory Science of Medical Devices, National Medical Products Administration, also known as Institute of Regulatory Science of Medical Devices, Sichuan University, and West China Hospital of Sichuan University. The pilot training was successful, and all indicators are all-time record of RHSC. In June 2020, RHSC held a global teleconference with 78 participants from all 18 APEC economies, 15 universities/research institutions, 7 global pharmaceutical industry organizations, and experts and officials from five international organizations such as the World Health Organization (WHO), the International Conference on Harmonization (ICH) and (International Medical Device Regulators Forum, IMDRF), passed the application of APEC Center of Excellence. Sichuan University has become China's first center of excellence in medical devices regulatory science.

Goal:

Ÿ To create an open and sustainable academic platform for the cooperation of government, academia and industry, and promote the integrated development of medical devices activities

Ÿ Strengthen the internationalization of medical device pre-marketing standards to better protect the public health of APEC economies

Ÿ Sustainable risk benefit assessment and management of medical products

Ÿ Accelerate the provision of more innovative and safer medical equipment

Task：

Ÿ Regulatory science study: develop new scientific tools, standards and methods, and provide scientific evidence and suggestions for the formulation of China's medical device regulatory policies, guidelines and standards

Ÿ International communication and cooperation: organize or participate in international conferences and seminars related to the regulation of medical devices, and select experts to actively participate in the formulation of relevant international organizations and technical rules

Ÿ Talents cultivation: to provide professional and systematic training to improve the regulation ability of relevant practitioners of government, academia and enterprises, and promote the coordination of medical device regulation