Principal Investigator (PI): YuanJia HU, Professor
Year: 2024
“The drug registration and access system in the GBA is closely related to regulatory science in terms of standards coordination, cross-border cooperation, and regulatory innovation. In order to strengthen cooperation in the pharmaceutical field in the GBA and improve the drug evaluation and approval system, this project mainly focuses on Macao and conducts research around the content of the drug registration and admission system.”
Regulatory Science Challenge
With the great demand for Macao’s development of appropriate economic diversification, it is urgent to develop the registration and access system emphasized in the “Construction Plan for the Chinese Medicine Highlands in the Guangdong-Hong Kong-Macao Greater Bay Area (2020-2025)” and other guidelines. The drug registration and access system in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) is closely related to regulatory science in terms of standards coordination, cross-border cooperation, and regulatory innovation. For standards coordination, drug registration and access supervision in the GBA involves different regulatory systems and mechanisms. Therefore, linking drug registration and access standards from different regions with the management and formulation of regulatory science is conducive to sorting out the entire process supervision supporting systems and management methods, seizing the opportunities of Bay Area connectivity and promoting the development of China’s big health industry. There is cross-border drug research and development, production and sales activities in the GBA. The “Hong Kong and Macau Registered Medicine Access to GBA Program” promulgated by the National Medical Products Administration in 2022 allows designated medical institutions in the GBA to use drugs and medical devices that are urgently needed for clinical use after approval by Guangdong Province. Cross-border cooperation can promote consistency in drug regulation across regions and avoids duplication of approvals and regulatory loopholes. For regulatory innovation, the close correlation between the drug registration and access system and regulatory science can promote exchanges and cooperation in scientific and technological innovation and application, promote the development of drug R&D and innovation, and improve the competitiveness and international influence of the pharmaceutical industry.
Project Description
This study aims to explore the current status of the drug registration and access system in the GBA, and analyze the policies of its drug registration and access system from the three entities of the mainland, overseas and Macao, so as to gain an in-depth understanding of how the system operates, policy frameworks and cross-border cooperation mechanisms to promote the orderly development of China’s pharmaceutical regulatory system.
This study applies mixed methods, including literature review, policy analysis, case studies and expert interviews, etc., to conduct an in-depth analysis of the operating mechanism and policy framework of the drug registration and access system in the GBA, to improve the registration and access system in the GBA from the perspective of policymakers, to promote the integration of regulatory standards with international ones from the perspective of overseas cooperation, and to provide experience and reference for cooperation in the registration and access system from the perspective of cross-border drug access and regional collaboration, thus to promote inter-regional drug safety and development and innovation of pharmaceutical industries.
Research Posters
