2025 marks the first anniversary of the implementation of the "Opinions of the General Office of the State Council on Fully Deepening the Reform of Drug and Medical Device Supervision and Promoting the High Quality Development of the Pharmaceutical Industry". This year, Guangdong has implemented the reform of major national drug and equipment review and approval, deepened the innovation of drug and equipment supervision in the Greater Bay Area, and taken solid steps to promote the high-quality development of the pharmaceutical industry in the province. The combination of speed and innovation has accelerated the release of a series of innovative policies in drug and device regulation in the Greater Bay Area, represented by the "Hong Kong Macau Drug and Device Connect" in Guangdong Province. These policies not only benefit patients in the Greater Bay Area, but also have a profound impact on the development of the biopharmaceutical industry in the region. Among them, 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. Currently, there are 71 designated medical institutions, and 146 varieties of Hong Kong and Macau drugs and medical devices have been approved for introduction and use, benefiting about 17000 patients. Professor Yin Xiaoyu, Vice President of the First Affiliated Hospital of Sun Yat sen University and leader of the Department of Hepatopancreatic Surgery, introduced that Sun Yat sen First Hospital actively introduces advanced medical equipment through the "Hong Kong Macau Medical Equipment Connect" policy. Medical equipment covers cutting-edge specialties such as cardiology, vascular surgery, otolaryngology, and neurosurgery, while drugs focus on urgently needed clinical fields such as tumors, rare diseases, cardiovascular diseases, and neuroscience, providing patients with more diverse and efficient treatment options. In terms of medical devices, taking the EKOS ultrasound assisted thrombolysis control system and catheter as an example, this product is the world's first ultrasound assisted thrombolysis intervention device approved by the US FDA for pulmonary embolism. As the first introduction unit in mainland China, Zhongshan First Hospital successfully carried out the first case of using this device to treat pulmonary embolism in mainland China, bringing a safe and effective new treatment plan for critically ill patients in the local area. Yin Xiaoyu said that the Hong Kong and Macao medicine and equipment introduced by Zhongshan First Hospital closely followed the core requirements of the policy, with two characteristics of "clinical urgency" and "application progressiveness". At the same time, it closely combined the actual needs of patients and the hospital's advantageous discipline layout to carry out project selection, application and clinical application. To ensure the safety of patient use, the introduction of relevant products is first applied for by the clinical department. After evaluation by multiple departments within the hospital, review by the ethics committee, and approval by the pharmaceutical or medical device related committee, a formal application is submitted to the Guangdong Provincial Drug Administration; After approval, complete the supporting work such as medical insurance code application and fee item filing synchronously, and then start clinical use; Throughout the entire process, the hospital uses UDI scanning and traceability technology for closed-loop management, effectively ensuring the safety and reliability of Hong Kong and Macau pharmaceutical equipment. Yin Xiaoyu believes that in the future, efforts can be made to deepen medical and health cooperation in the Greater Bay Area from multiple aspects. By relying on the existing channels of the "Hong Kong Macau Medical Device Connect", we can expand the scope of introducing urgently needed clinical medical devices; Jointly carry out real-world research on innovative medical devices, providing evidence-based support for the registration of high-quality medical devices from Hong Kong and Macau in mainland China; Explore the establishment of a collaborative mechanism for drug and equipment procurement in the Greater Bay Area, reduce introduction costs, and enhance patients' access to advanced treatment resources. Establish a mechanism for the exchange of data on drug and equipment use and adverse reaction monitoring in the Greater Bay Area, and achieve real-time sharing of drug and equipment safety data; Explore the integration and standardization of clinical use norms and quality control standards for urgently needed medical devices, providing data support and standard compliance for the rational use of cross regional medical devices. In addition to the "Hong Kong Macau Medical Device Connect", the Guangdong Provincial Medical Products Administration has also made a series of layouts to further expand the development space of the pharmaceutical industry in the Greater Bay Area. For example, simplify the registration and approval process of traditional traditional Chinese patent medicines and simple preparations for external use, and promote 18 Hong Kong and Macao drugs to be approved for listing in the mainland quickly and easily; Pioneering the management model of "Hong Kong and Macau holding+Bay Area mainland production", three Hong Kong drugs have been put into production and launched in the Bay Area mainland; Promote the use of Macau drugs in the Hengqin Guangdong Macau Deep Cooperation Zone, and determine two batches of designated Macau drugs, totaling 367 varieties and 545 specifications, to enter the zone for use by Macau residents. In addition, there are 233 registered enterprises in the Guangdong Macao Cooperation Traditional Chinese Medicine Technology Industrial Park, including 98 enterprises in Macau; Since the establishment of Zhongshan Pharmaceutical Import Port in 2021, the declared value of goods has exceeded 1.07 billion yuan; Approved 10 high-quality Chinese medicine preparations from two medical institutions, including Guangdong Provincial Traditional Chinese Medicine Hospital and Foshan Traditional Chinese Medicine Hospital, for cross-border clinical use at Jinghu Hospital in Macau, deepening the cooperation between Guangdong and Macau in medical and health care. The policy "Timely Rain" Spring Rain Action helps to transform clinical research results of medical devices. The in-depth implementation of the "Spring Rain Action" provides a key solution to solve the problem of "unwillingness, reluctance, and inability to transform" in the transformation of clinical research results of medical devices. In July of this year, the Guangdong Provincial Medical Products Administration held a policy promotion and exchange meeting for the Spring Rain Action on Guangzhou Bio Island, focusing on industry chain collaboration and promoting innovation in medical device sources guided by clinical value. It is reported that 182 projects have entered the second round of comprehensive evaluation, including 96 projects for three types of medical devices, 71 projects for innovative products, and 118 projects for the first product. Based on long-term clinical practice and research accumulation, Professor Liu Huanliang, the leader of the Clinical Laboratory Science Department at the Sixth Affiliated Hospital of Sun Yat sen University, and his team have identified prominent clinical pain points in the management of postoperative nausea and vomiting (PONV) in patients, and continue to explore feasible solutions. Liu Huanliang stated that the Spring Rain Action is an important measure to promote the transformation of innovative achievements at the source of medical devices. On the one hand, through the communication, consultation, and docking platform for the transformation of clinical research results of medical devices provided by the Guangdong Provincial Medical Products Administration, relevant projects are jointly participated by the government, hospitals, research, enterprises, finance, and other platforms, allowing regulatory authorities, industry, and financial institutions to systematically understand the needs of clinical innovation; On the other hand, the existence of a communication and docking platform for the transformation of clinical research results in medical devices provides the team with an opportunity to advance relevant cooperation earlier, communicate with review experts and enterprises about possible registration paths and product forms in the future. Consider conversion requirements in advance during research to reduce the need for backtracking. Therefore, Liu Huanliang believes that the Spring Rain Action is more like a high-energy connector and amplifier for the transformation of scientific research achievements, providing a platform for communication and exchange among relevant parties, and promoting the accelerated transformation of research results. Liu Huanliang introduced that the team has completed concept certification and developed a prototype system for predicting postoperative nausea and vomiting. The model packaging, process design, and interface prototype have been completed, and further clinical research has been conducted to enhance the future implementation and transformation. He also hopes to unite all parties and accelerate project transformation through the Spring Rain Action, further assisting in a healthy China. In October 2024, Guangdong Province issued the "Action Plan for Further Promoting the High Quality Development of Guangdong's Biopharmaceutical Industry", which aims to accelerate the clinical trial review and approval process of innovative drugs and promote the use of innovative drugs and medical devices in hospitals, among other aspects, to promote the agglomeration of Guangdong's biopharmaceutical industry. The Guangdong Provincial Drug Administration is fully committed to implementing the provincial government's action plan for high-quality development of the biopharmaceutical industry, carrying out drug and device evaluation with a focus on pre evaluation, research and review linkage, rolling evaluation, and AI assistance. Since 2025, a total of 16 innovative drugs and 17 innovative medical devices have been approved in the province. In 2025, one of the core products independently developed by Kangfang Biotechnology, Ivo Xidan Kang, was approved for a new indication. Dr. Zhang Peng, co-founder of Kangfang Biotechnology, discussed this matter and stated that the guidance and support from the drug regulatory authorities for innovative enterprises are important reasons for the sustained high-quality development of China's biopharmaceutical industry in recent years. The application and listing of innovative drugs is a standardized, rigorous, scientific, and highly complex process. During the listing process of the company's five innovative drugs, the drug regulatory department provided valuable opinions and suggestions. Zhang Peng cited the example of Ivoxidan Kang, which was approved for PD-L1 positive non-small cell carcinoma indication in 2025. With clinical data and innovative mechanism of action, it obtained breakthrough therapeutic drug qualification recognition from the National Medical Products Administration during clinical research and development, and was granted priority review and approval during the market application stage, greatly accelerating the product's market launch process. He particularly mentioned that in the process of writing application materials in the early stage, the drug regulatory department suggested that in the "Process Development History" section, enterprises should present the process versions, batch numbers, uses, raw materials, sites, and other contents involved in the product process development process in the form of a list one by one. Detailed guidance has been provided on the comparability research required for the product, clarifying the content of the application materials while optimizing the form of the materials, making the application materials more comprehensive and specific, saving communication time with the reviewers, and effectively promoting the review process. During the material preparation process, the company also deepened its understanding of innovative drug application, and was able to describe the technical advantages of the product more clearly and smoothly in the subsequent application of products and indications, promoting the process of new drug application and approval. Zhang Peng stated that in the process of expanding production capacity, Kangfang Biotechnology has also actively communicated with the National Medical Products Administration with the careful and comprehensive assistance of the Guangdong Provincial Medical Products Administration. Under the guidance of relevant departments, the company scientifically assesses the level of changes in the production line after the product is launched, in order to meet a wider range of clinical needs, including those of patients worldwide. The policy innovation and assistance from regulatory authorities have enabled enterprises to accelerate research and development, enabling patients to use innovative drugs in a timely manner, and have also made significant contributions to the development of the innovative biopharmaceutical industry in Guangdong Province and even the whole country. Drug launch is an important step in the true transformation of drug innovation value into social and economic value. Zhang Peng said that in recent years, the national and local governments have introduced a series of relevant policies to support the full chain development of the innovative drug industry. These innovative measures can truly implement the accessibility of innovative drugs, improve the level of patient protection, and make enterprises more willing to invest, research and develop, and innovate. The approval and launch of the product is only the first step in the full lifecycle management. Therefore, the company is also developing new indications to meet the needs of a wider range of cancer patients. "Enabling patients to benefit from innovative products earlier is an important mission and goal of the enterprise." In addition, the Guangdong Provincial Medical Products Administration fully leverages the advantages of the high-quality development work mechanism of the biopharmaceutical industry, and works with departments such as industry and information technology, health, and medical insurance to coordinate key project research and development and industrialization element guarantees, forming a catalog of 107 innovative medical device products (the first batch), researching and supporting innovative medical device admission measures, and helping to solve the problems of difficult admission and use of innovative medical devices. In November 2024, the National Medical Products Administration (NMPA) issued a reply on approving the pilot reform of the review and approval procedures for optimizing drug supplementary applications in ten provinces (cities) including Beijing. The reply aims to optimize the review and approval procedures for drug supplementary applications. Among them, Guangdong Province was among the first to receive approval from the NMPA to carry out the pilot reform of the review and approval procedures for optimizing drug supplementary applications, reducing the review and approval time for Guangdong varieties from 200 working days to 60 working days. It is reported that the Guangdong Provincial Medical Products Administration has received 64 applications and completed 58 reviews, of which 8 have been approved by the National Medical Products Administration. Feng Wei, co-founder and general manager of Guangzhou Rui'er Pharmaceutical, introduced that under the drug change management model in China, enterprises promoting the technological upgrading and iteration of drugs will face many change requirements. Among them, medium and small change enterprises can implement them in a timely manner, while major changes need to be approved by the National Medical Products Administration before they can be implemented. The approval deadline has become a speed limiting step that restricts the rapid iteration of enterprise products. Feng Wei stated that after learning that Guangdong Province has launched supplementary application pre service as a pilot province, the company quickly applied to the Guangdong Provincial Drug Administration. in Guangdong Province