On the morning of September 26, 2023, Pharmaceutical Policy Sharing Forum under the theme of Coordinated and Innovative Development of Drug and Medical Devices Regulation in the Greater Bay Area was held. Dong Jiangping, director-general, China Center for Food and Drug International Exchange, deputy director-general, Guangdong Medical Products Administration, Lei Sai Ian, deputy director, Pharmaceutical Administration Bureau, Macao SAR, and LAM Fung Shing, chief pharmacist, Drug Office, Department of Health, Hong Kong Special Administrative Region were invited to address keynote speeches focusing on the topic of the innovative regulation of medical devices and coordinated industrial development. This is the first time that departments of regulation from Guangdong, Hong Kong and Macao gathered in the region beyond the Greater Bay Area, to share regulation experience and discuss future prospects of cooperation with NMPA. Representatives from departments of regulation and industry were invited to participate in the panel with the topic of Promoting Drug and Medical Device Regulatory Coordination in the Greater Bay Area, Forging a High-level and Internationalized Development of Pharmaceutical Innovation. Song Ruilin, executive president of China Pharmaceutical Innovation and Research Development Association (PhIRDA), made a welcome remark. The forum was chaired by Feng Lan, secretary-general of PhIRDA.

01

Dong Jiangping addressed a keynote speech entitled High-level Openness Based on High-quality Development — International Cooperation and Exchange in Drug Regulation. Dong pointed out that, promoting Chinese drugs accessing international markets is a systematic project, involving various factors with mutual recognition of regulation rules as an important one. On August 23, 2022, China’s vaccine regulatory system passed WHO assessment once again, which shows the recognition from the international community to China’s vaccine regulatory capacity. The National Medical Products Administration (NMPA) applied for accession to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in this September.

02

Wang Ling, deputy director-general, Guangdong Medical Products Administration, addressed a keynote speech entitled Integration and Prospects of Innovation of Drug and Medical Device Regulation in the Guangdong-Hong Kong-Macao Greater Bay Area based on the practices of innovative regulation in Guangdong. Wang said, following the signing of Memorandum of Cooperation in the Regulation of Drugs and Medical Devices in the Guangdong-Hong Kong-Macao Greater Bay Area, there is an increasingly closer coordination in the three regions. Now, remarkable progress and achievements have been made in the following seven aspects, the implementation of Hong Kong and Macao Medicine and Equipment Connect policy, the Simplification of Registration Approval Procedures for Hong Kong- and Macao-registered Traditional Proprietary Chinese Medicines Intended for External Use, Contract Manufacturing of Hong Kong Medical Device and Drug in GBA, Guangdong-Hong Kong-Macao Greater Bay Area Center for Medical Device Evaluation and Inspection of NMPA propelling the regional development, Traditional Chinese Medicine Science and Technology Industrial Park of Co-operation between Guangdong and Macao, the construction of Zhongshan port shore as the drug import port, and availability of drugs in Guangdong-Macao in-depth cooperation zone in Hengqin.

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Lei Sai Ian addressed a keynote speech entitled Building a Regulatory System for Drug and Medical Devices in Macao, Integrating it’s Development into the Overall Development of China. Lei pointed out that Pharmaceutical Administration Bureau of Macao SAR, established just on January 1, 2022, has undertaken important development tasks of drug regulation and industrial development, with the GBA as one of priorities.

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LAM Fung Shing addressed a keynote speech entitled Looking Forward to the Integrated Development of Drug Regulation in Hong Kong and the Greater Bay Area, Leveraging Hong Kong’s Advantages. He said, at present, Hong Kong and the GBA have medical devices regulation and coordination in fields as follows: first, the NMPA recognized drug clinical trials organizations in Hong Kong and their clinical data, which will facilitate innovative drugs entering the market in the Chinese mainland; second, effective on November 1, 2022, Chinese mainland was listed as one of the reference regions in Hong Kong; third, the deeper implementation of Hong Kong and Macao Medicine and Equipment Connect and Contract Manufacturing of Hong Kong Medical Device and Drug in GBA; last, Department of Health, HK SAR has always proactively maintained exchanges with Guangdong-Hong Kong-Macao Greater Bay Area Center for Medical Device Evaluation and Inspection of NMPA.

Panel unfolded with the focus of Promoting Drug and Medical Device Regulatory Coordination in the Greater Bay Area, Forging a High-level and Internationalized Development of Pharmaceutical Innovation, with Jiang Jie, dean of the Real World Research Institute of Medicines and Medical Devices, Guangdong Hong Kong Macao Greater Bay Area of Jinan University as the moderator. Song Ruilin, Liang Yun, Hu Yuanjia, John Wan, senior vice president and chief operations officer, Betta Pharmaceuticals Co., Ltd. and Martin Guo, vice president, Government Affairs and Market Access, LianBio shared their opinions on the topics about “further improving the accessibility and affordability of patients based on the policy of Hong Kong and Macao Medicine and Equipment Connect” and “Promoting drug and medical device regulatory coordination in the GBA by leveraging their respective advantages”.

First, participants highly recognized the achievements made through the implementation of Hong Kong and Macao Medicine and Equipment Connect policy. Meanwhile, they showed that regulatory coordination of medical devices in the GBA should seize the opportunities provided by national policies, and leverage the advantages of the “One Country, Two Systems” policy, provide regulation facilitation and mutual reliance on the basis of information sharing and exchanges to develop regulatory science, reach regulatory consensus. precisely grasp the positioning of the Hong Kong and Guangdong regions. Generally, the coordination should take the Chinese mainland as the foundation to embrace a global vision, exploring a development path of high-quality development of Guangdong-Hong Kong-Macao drug and medical device regulation, accelerating the journey of China’s pharmaceutical innovation towards internationalization.

Photo of Jiang Jie, Hu Yuanjia, Liang Yun, John Wan, and Martin Guo (From Left to Right)

Photo of LAM Fung Shing, Lei Sai Ian, Dong Jiangping, Song Ruilin, Wang Ling and Yang Yihui (From Left to Right)