On October 9, the Information Office of the Guangdong Provincial Government hosted a press conference to introduce the “Action Plan for Promoting High-Quality Development of the Biotechnology and Pharmaceutical Industry in Guangdong.” During this event, it was highlighted that Guangdong has successfully facilitated the introduction of 79 types of drugs and medical devices from Hong Kong and Macau, benefiting nearly 10,000 residents in the Greater Bay Area.
Wang Ling, the Deputy Director of the Guangdong Provincial Drug Administration, shared insights on the implementation of the “Hong Kong and Macau Drug and Device Access” policy initiated in 2021. This policy establishes a fast track for internationally advanced innovative drugs and devices to enter clinical use. It allows for the use of drugs that have been approved in Hong Kong and Macau, as well as medical devices purchased by public hospitals in those regions, to be utilized in designated medical institutions throughout the Greater Bay Area when urgent needs arise.
Currently, the “Hong Kong and Macau Drug and Device Access” program includes 45 designated medical institutions, ensuring coverage for all nine cities in the Greater Bay Area. This initiative has piqued the interest of global multinational pharmaceutical and medical device companies in the Guangdong region.
On July 31 of this year, the Standing Committee of the Guangdong Provincial People’s Congress adopted the “Regulations on the Management of Imported Drugs and Medical Devices from Hong Kong and Macau in the Nine Cities of the Greater Bay Area.” This regulation builds on the existing policy framework and introduces a catalog management system for urgently needed drugs and devices from Hong Kong and Macau, which will be dynamically adjusted and promptly communicated to the public based on clinical requirements and the approval status of these products. The review and approval processes for necessary imports have been significantly streamlined, cutting the approval time for urgently needed products outside the catalog from 35 working days to just 20 days, and reducing the time for those within the catalog from 25 days to 10—an average decrease of 50%. This marks a significant shift from “waiting for drugs” to “drugs waiting for people.”
Furthermore, global multinational pharmaceutical and medical device companies are encouraged to tap into the high-quality medical resources of the Greater Bay Area. Through the “Hong Kong and Macau Drug and Device Access” policy, these companies are invited to conduct real-world research on urgently needed products at designated medical institutions, while adhering to national technical guidelines. This will support their applications for registration and market entry of effective products in mainland China.
