From the "Hong Kong Macau Medical Device Connect" to enable innovative medical devices to benefit patients with "zero time difference", to the reshaping of the industrial chain through the "overseas holding+domestic production" model; From the first cross-border entry of Lingnan traditional Chinese medicine preparations into Australia, to the normalization of regulatory cooperation among the three regions... Now, on the land of the Guangdong Hong Kong Macao Greater Bay Area, a vivid picture of "soft connectivity" in the field of biomedicine and health is vividly presented. On February 18th, 6 years ago, the "Outline of the Development Plan for the Guangdong Hong Kong Macao Greater Bay Area" was announced and implemented. The Guangdong Provincial Medical Products Administration, with the courage to "break through", the spirit of "innovation", the rhythm of "grabbing", and the style of "doing", took the innovation of the regulatory system for drugs and medical devices (hereinafter referred to as "drugs and devices") as a breakthrough point, actively broke down the cross-border barriers to the circulation of drugs and devices in the Guangdong Hong Kong Macao Greater Bay Area, activated new driving forces for the integration and development of the biopharmaceutical industry through rule linkage and mechanism docking, bravely became a pioneer in the high-quality development of the biopharmaceutical industry, and built a biopharmaceutical industry ecosystem that is in line with the international. The data shows that by the end of 2024, the Guangdong Hong Kong Macao Greater Bay Area has introduced 97 kinds of innovative drugs and equipment through the "Hong Kong Macao Drug and Equipment Connect", with the product value of nearly 300 million yuan, the cross-border entrusted production sales of nearly 100 million yuan, and 15 traditional Chinese patent medicines and simple preparations from Hong Kong and Macao have accelerated their "breakthrough" in the mainland market... The policy dividend has been transformed into the people's temperature, and the Bay Area speed superposition system has been innovated. Guangdong Food and Drug Administration has taken the lead in the past six years, and delivered a brilliant answer in the regulatory innovation of drugs and medical devices in the Guangdong Hong Kong Macao Greater Bay Area.

The 'Hong Kong Macau Medical Device Connect' accelerates the landing of global innovative drugs and devices

Since its implementation in 2021, the "Hong Kong Macau Medical Device Connect" has quietly changed the layout of the biopharmaceutical industry in the Guangdong Hong Kong Macau Greater Bay Area. According to data from the Guangdong Provincial Medical Products Administration, as of the end of December 2024, the "Hong Kong Macau Drug and Device Connect" policy has successfully opened up a channel for innovative drugs and devices used in Hong Kong and Macau to quickly enter clinical applications in the Guangdong Hong Kong Macau Greater Bay Area. There are 45 designated medical institutions with 97 varieties, including 49 types of drugs and 48 types of devices, benefiting nearly 10000 residents in the Greater Bay Area.

With the continuous expansion of the influence of the "Hong Kong Macau Medical Device Connect", it has gradually become a key link in leveraging international innovative medical devices to enter the Chinese market, and has also made the Guangdong Hong Kong Macau Greater Bay Area a new highland for the global biopharmaceutical industry competition. The Greater Bay Area has top-notch medical resources and policy flexibility, which has shortened the time for our overseas drugs and devices to be introduced into the domestic market by at least one-third, "said Peng Zhenke, President of Pfizer China. Currently, Pfizer has introduced two new drugs through the" Hong Kong Macau Medical Device Connect ". Among them, the first real-world research project in the Guangdong Hong Kong Macao Greater Bay Area has been launched for the oral disintegrating tablets of remifentanil sulfate. Currently, the real-world research of this variety has helped the product to be officially registered and launched in China. "Hong Kong Macao Pharmaceutical Equipment Connect" not only injects Guangdong's bio pharmaceutical industry with the world's top technology, but also stimulates the local innovation vitality in the reverse direction - in 2024, 7 of the 19 innovative drugs approved in Guangdong are Class 1 new drugs, with a year-on-year surge of 133% in the number; Among the 14 innovative medical devices, the three types of devices with high gold content account for 6 seats. The innovation of drug and equipment regulation in the Guangdong Hong Kong Macao Greater Bay Area is not only reflected in breakthrough policies, but also in greater legislative guarantees. On December 1, 2024, the "Regulations on the Administration of Imported Drugs and Medical Devices from Hong Kong and Macao in Nine Mainland Cities of Guangdong Hong Kong Macao Greater Bay Area" officially came into effect, providing legislative protection for the "Hong Kong Macao Drug and Medical Device Connect" policy. By simplifying the review procedures and speeding up the review process, the concept of "people waiting for medicine" has been transformed into "medicine waiting for people". At the "Macau New Neighborhood" health station in Hengqin, Zhuhai, 166 Macau medicines are regularly supplied through a special channel; Behind the 840 million yuan import of drugs at Zhongshan Port is the resonance effect of port economy and innovation policies. These application scenarios are transforming policy dividends into tangible benefits for people's livelihoods. Ms. Xiao, a 60 year old late stage cervical cancer patient, recently saw a turning point at Sun Yat sen Memorial Hospital of Sun Yat sen University - through the "Hong Kong Macau Drug and Device Connect" policy, she became one of the first patients in China to use the globally innovative ADC drug, rituximab. It is reported that the hospital immediately initiated the application process after obtaining approval for the drug in Macau, completing the admission process in just three months. The innovative mechanism of "waiting for patients to receive medication first" allows patients to receive treatment upon arrival at the hospital. Reshaping the biopharmaceutical industry in the Greater Bay Area through 'overseas holdings+domestic production'

On the intelligent production line of Zhuhai United Pharmaceutical Zhongshan Branch, vitamin C effervescent tablets are being filled in an orderly manner... This batch of "overseas holding+domestic production" products has received many positive reviews from consumers since its launch and sale in mainland China in June 2023; In Jiangmen, the "Musk Activating Oil" production line of the century old Hong Kong brand Diyuantang also operates around the clock - this bottle of traditional Chinese patent medicines and simple preparations for external use, which was once limited by the space of Hong Kong and Macao factories, has now increased its capacity several times through cross-border commissioned production. In June 2022, the National Medical Products Administration released the "Implementation Plan for Supporting Hong Kong and Macao Drug Marketing Authorization Holders to Produce Drugs in Nine Cities in the Greater Bay Area" and the "Implementation Plan for Supporting Hong Kong and Macao Medical Device Registered Persons to Produce Medical Devices in Nine Cities in the Greater Bay Area", opening a new institutional window for the deep integration of the biopharmaceutical industry in the Guangdong Hong Kong Macao Greater Bay Area: allowing Hong Kong and Macao drug and device licensed enterprises to relocate their production processes to nine cities in the Greater Bay Area. This pioneering "overseas holding+domestic production" management model will also provide a good practical platform for deepening the reform of the drug marketing authorization holder system in the Guangdong Hong Kong Macao Greater Bay Area, and exploring a drug marketing authorization holder system that is in line with international standards. The Guangdong Provincial Drug Administration actively responds to the demands of Hong Kong and Macao enterprises, and comprehensively accelerates the process of promoting the production and listing of Hong Kong and Macao drugs in mainland China. Especially in policy implementation, a dedicated channel has been opened for handling provincial-level administrative licensing matters such as entrusted production enterprises applying for changes to their Drug Production License. The policy has been implemented for nearly three years, and the reform dividend has been released at an accelerated pace. According to the data of Guangdong Provincial Food and Drug Administration, at least five Hong Kong and Macao pharmaceutical enterprises have started cross-border production layout, involving chemical drugs, traditional Chinese patent medicines and simple preparations and other varieties. Cross border production brings not only spatial transfer, but also the reconstruction of industrial chain value. From the efficient operation of the Vitamin C effervescent tablet production line to the leap in production capacity of the century old pharmaceutical oil brand, cross-border commissioned production not only solves the "growth troubles" of Hong Kong and Macao pharmaceutical companies, but also reshapes the global competitiveness of the biopharmaceutical industry in the Guangdong Hong Kong Macao Greater Bay Area. The "Bay Area Solution" for Traditional Chinese Medicine Inheritance and Innovation

On October 25, 2023, traditional Chinese medicine preparations from mainland medical institutions were cross-border for the first time to be used in Macau. On that day, six star hospital preparations from Guangdong Provincial Hospital of Traditional Chinese Medicine were sent to Macau, including the "Gusong'an Capsule" for treating osteoporosis and the Lingnan specialty "Appetizer and Spleen Awakening Drink". The preparations were received by Jinghu Hospital and will gradually be applied in clinical practice.

Guangdong and Macao have good geographical advantages, and people's medication habits are similar. As a strong province in traditional Chinese medicine, Guangdong Province has many medical institutions that have their own unique, clinically effective, and Lingnan style classic and tested formulas, which are a huge treasure trove for the development of traditional Chinese medicine preparations. According to the relevant person in charge, the six formulations of "Guanguan" have a long history, definite efficacy, safety and effectiveness, and controllable quality. The cross-border entry of Chinese medicine preparations by mainland medical institutions into Macao has filled the gap in the cross-border use of Chinese medicine preparations by domestic medical institutions. It is also a major progress in the joint supervision of traditional Chinese patent medicines and simple preparations in the Guangdong Hong Kong Macao Greater Bay Area, which has accumulated experience for the regulatory innovation and integrated development of the Chinese medicine industry in the Guangdong Hong Kong Macao Greater Bay Area. The high-quality development of the traditional Chinese medicine industry cannot be achieved without policy guidance and professional platform support. The State Food and Drug Administration entrusted the review and approval of the registration of traditional Chinese patent medicines and simple preparations for external use that has been listed in Hong Kong and Macao, and Guangdong Food and Drug Administration guided Hong Kong and Macao enterprises to prepare registration application materials "one-on-one" through front guidance and special docking; The original materials for registering and declaring varieties in Hong Kong and Macau can be used for registration and declaration in mainland China; Support measures such as simplified registration and listing of traditional traditional Chinese patent medicines and simple preparations with their clinical use history in Hong Kong and Macao for many years, and promote the technical review time of traditional Chinese patent medicines and simple preparations for external use in Hong Kong and Macao to be shortened from 200 days to 80 days. At the same time, through the docking of drug regulatory mechanisms in Guangdong, Hong Kong and Macao, the production site inspection and system verification in the mainland listing approval process of traditional traditional Chinese patent medicines and simple preparations can be reduced. Changes made after listing, if the relevant changes are approved in Hong Kong and Macau, can also apply to adjust the approval process to filing. As of December 20, 2024, 15 varieties have been approved for listing, of which Macao has achieved "zero breakthrough" in the registration and listing of traditional Chinese patent medicines and simple preparations products in the mainland. Nowadays, the inheritance, innovation and development of traditional Chinese medicine in the Guangdong Hong Kong Macao Greater Bay Area are accelerating. On September 5, 2024, three traditional Chinese patent medicines and simple preparations R&D samples for mainland registration were successfully imported from Macao through Hengqin Port to the wholly-owned subsidiary of the Industrial Park, Yue'ao Pharmaceutical Co., Ltd. Hengqin Yue'ao Deep Cooperation Zone achieved the first breakthrough in the successful import of traditional Chinese patent medicines and simple preparations R&D samples for mainland registration. The "Guangdong Hong Kong Macao Traditional Chinese Medicine Policy and Technology Research Center" and other platforms established by the Guangdong Hong Kong Macao Cooperation Traditional Chinese Medicine Technology Industrial Park have helped to moderately diversify the Macau economy, and have assisted in the registration and listing of 19 pharmaceutical and medical products in Portuguese speaking countries. The Guangdong Hong Kong Macao Greater Bay Area is rewriting the narrative of the globalization of traditional Chinese medicine. When ancient wisdom meets the speed of the Bay Area, and traditional prescriptions collide with regulatory innovation, what emerges here is not only the drugs themselves, but also the construction system of modernization of traditional Chinese medicine. Normalized operation of drug regulatory cooperation among Guangdong, Hong Kong, and Macao

The reform of the system for drug marketing authorization holders and medical device registrants in the Guangdong Hong Kong Macao Greater Bay Area... The institutional innovation of the drug regulatory cooperation mechanism among Guangdong, Hong Kong, and Macao is not simply policy superposition, but a further rule reconstruction.

Previously, the regulatory departments of Guangdong, Hong Kong, and Macao signed the "Memorandum of Cooperation on Drug and Medical Device Supervision in the Guangdong Hong Kong Macao Greater Bay Area", establishing a "four beams and eight pillars" of institutional coordination. The "three carriages" of the work coordination group, joint meeting mechanism, and standardization expert committee have shifted cross-border supervision from temporary cooperation to regular operation. In recent years, with the overall goal of building the Guangdong Hong Kong Macao Greater Bay Area, the Guangdong Provincial Drug Administration has made every effort to promote comprehensive reform of drug regulation, continuously improve regulatory mechanisms, innovate regulatory methods, accelerate the modernization of the drug regulatory system and regulatory capacity, and further enhance the speed at which Guangdong's drug regulatory capacity has reached the international advanced level. The relevant person in charge of Guangdong Provincial Drug Administration stated that the bureau has always regarded expanding services and optimizing the business environment as important tasks, achieving the unity of regulatory and service functions, and helping the steady development of the biopharmaceutical industry. At the same time, we will play a leading and exemplary role, continue to explore new models of cooperation in pharmaceutical and medical equipment among Guangdong, Hong Kong, and Macao, promote the integrated development of the three regions, and enable more pharmaceutical and medical equipment enterprises in Guangdong, Hong Kong, and Macao to enjoy convenient discounts. In order to implement innovative regulatory policies in the Guangdong Hong Kong Macao Greater Bay Area, we will further increase publicity efforts, introduce relevant supporting policies and measures, shape a favorable policy environment and industrial ecology, gather industrial elements, integrate development advantages, and accelerate the high-quality development of the biopharmaceutical industry in the Guangdong Hong Kong Macao Greater Bay Area, "said the person in charge.

Source: Southern Daily News