To thoroughly implement the spirit of the Third Plenary Session of the 20th CPC Central Committee and the arrangements set forth in documents such as the “Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Drug and Medical Device Supervision to Promote High-Quality Development of the Pharmaceutical Industry” (State Council General Office Document [2024] No. 53), we will adhere to the principle of prioritizing reform and emphasizing supervision, comprehensively advance the reform of full-chain supervision of drugs and medical devices, and create a first-class business environment.By 2027, the drug and medical device regulatory system, regulatory efficiency, and regulatory standards will better meet the needs of pharmaceutical innovation and high-quality industrial development; by 2035, regulatory modernization will be basically achieved. In light of the actual conditions in our province, the following measures are hereby proposed.

I. Optimizing the Environment for the Innovative Development of Pharmaceuticals and Medical Devices

(1) Compile a List of Key Support Projects. Establish a consultation and coordination mechanism to compile a list of key support projects for innovative drugs, improved new drugs, first-in-class generic chemical drugs, vaccines, blood products, and innovative medical devices to be commercialized in our province, and improve supporting elements such as policies and funding.Accelerate the production and market launch of innovative biological products, blood products, and other industrial products within our province’s key industrial chains. Actively explore pilot programs for segmented production of relevant products to form a tailored, collaborative approach to full-process regulation and support. (Responsibility lies with the Provincial Development and Reform Commission, Provincial Department of Industry and Information Technology, Provincial Department of Science and Technology, Provincial Health Commission, Provincial Medical Insurance Bureau, and Provincial Drug Administration Bureau according to their respective duties)

(2) Boosting Services for the Pharmaceutical Industry. For newly submitted applications and products approved following the deepening of the review and approval system reform (including generic drugs that have passed the bioequivalence evaluation), registration testing will be processed on a first-come, first-served basis, with testing timelines shortened by 20%;For innovative drugs, the sample size required for each batch of registration testing will be reduced from three times the full-scale testing volume to two times; through pre-submission services and rolling submissions, the technical review time for post-market changes to manufacturing sites will be reduced by more than 50%. (Responsibility: Provincial Drug Administration)

(3) Provide comprehensive support for the innovative development of medical devices. Encourage enterprises, healthcare institutions, and research institutes to participate in “open challenges” for technologies such as artificial intelligence and biomaterials. Provide service guidance for the R&D and commercialization of our province’s winning products through “early engagement, tailored approaches for each enterprise, full-process guidance, and coordinated research and review.”Support Class II medical devices with clear clinical value and strong innovation to enter the special review procedure, reducing the review timeframe to within 30 working days and the system inspection timeframe to within 20 working days, while ensuring a smooth priority testing green channel. Encourage the relocation of production of Class II medical devices already marketed outside the province or imported into our province; conduct on-site production license inspections concurrently with registration system inspections, reducing the inspection timeframe to within 20 working days.(Responsibility lies with the Provincial Department of Industry and Information Technology, the Provincial Department of Science and Technology, and the Provincial Drug Administration, in accordance with their respective duties)

II. Fully Support the High-Quality Development of the Yunnan Pharmaceutical Industry

(4) Enhance the Recognition of High-Quality Yunnan Medicines. Carry out demonstration projects for the supervision and implementation of the “Good Agricultural Practice for Chinese Medicinal Materials” (hereinafter referred to as GAP). Promote the application of the “Medicinal Materials Conform to GAP Requirements” label and GAP traceability codes for Yunnan-produced medicinal materials to build a high-quality Yunnan medicine brand. Support domestic Chinese herbal decoction piece manufacturers in actively participating in centralized bulk procurement.Explore measures to encourage medical institutions to prioritize the use of TCM decoction pieces, TCM formula granules, and TCM preparations produced from GAP-compliant herbal materials. TCM formula granules manufactured in accordance with national pharmaceutical standards may be sold directly across provincial borders, and TCM decoction pieces processed in accordance with provincial processing specifications may be sold across provincial borders as prescribed. (Responsibility lies with the Provincial Department of Agriculture and Rural Affairs, the Provincial Medical Insurance Bureau, the Provincial Health Commission, and the Provincial Drug Administration Bureau, in accordance with their respective duties)

(5) Develop the TCM herbal material primary processing industry. Adhering to the principles of appropriate fresh-cut processing and quality assurance, promote full-chain traceability for TCM herbal material GAP, fresh-cut processing, and proprietary Chinese medicine production; standardize the management of on-site processing (fresh-cut processing) of TCM herbal materials; and establish a modern data support system for the Yunnan herbal medicine industry chain.Encourage manufacturers of TCM decoction pieces and proprietary Chinese medicines to establish, jointly build, or share TCM herbal production bases that meet GAP requirements. Explore mechanisms for mutual recognition of domestic and international standards for TCM herbs. (Responsibility lies with the Provincial Drug Administration, Provincial Department of Agriculture and Rural Affairs, Provincial Medical Insurance Bureau, Provincial Department of Commerce, Provincial Health Commission, and Provincial Market Regulation Bureau, in accordance with their respective duties)

(6) Improve the Yunnan herbal medicine standards system. Promote research on quality standards for the fresh processing of authentic Chinese herbal materials to enhance the standardization and normalization of on-site processing (fresh cutting) of Chinese herbal materials in our province.Encourage enterprises and research institutions to engage in the formulation and revision of standards for Chinese herbal materials, processing specifications for Chinese herbal slices, and standards for Chinese herbal formula granules. Guided by clinical needs, explore the adaptation of Chinese herbal formula granule standards already published in other provinces, and support the development of provincial processing specifications for Chinese herbal slices that address constraints on clinical prescription and medication use. (Responsibility lies with the Provincial Drug Administration, Provincial Department of Agriculture and Rural Affairs, and Provincial Health Commission according to their respective duties)

(7) Support the conversion of formulas from renowned physicians into new TCM drugs. Organize the selection of “Yunling Famous Formulas,” optimize the management of the dispensing and use of medical institution preparations, and ensure reimbursement by medical insurance funds in accordance with regulations. Establish an incentive mechanism for the translation of clinical achievements, encouraging provincial enterprises to focus on major chronic diseases, major intractable diseases, and pediatric medications to promote the conversion of selected medical institution preparations into new TCM drugs.Guide the collection and data management of empirical formulas used by National Masters of Traditional Chinese Medicine, National Renowned Senior TCM Practitioners, Yunling Renowned Physicians, and Provincial Renowned TCM Practitioners. Accelerate the conversion of empirical formulas into medical institution preparations through a review mechanism featuring “zero rework” and “zero waiting time,” reducing review timelines by more than 50%. (Responsibility lies with the Provincial Department of Science and Technology, the Provincial Health Commission, the Provincial Medical Insurance Bureau, and the Provincial Drug Administration Bureau, in accordance with their respective duties)

III. Continuously Enhance Compliance Standards in the Pharmaceutical Industry

(8) Strengthen post-marketing research and change management for key products. Encourage marketing authorization holders of TCM injections to conduct post-marketing research and re-evaluation. Continuously strengthen post-marketing change management, establish key information lists for products such as vaccines, blood products, products selected through centralized procurement, and special dosage forms, and enhance full lifecycle management capabilities. (Responsibility lies with the Provincial Department of Science and Technology and the Provincial Drug Administration Bureau according to their respective duties)

(9) Improve the efficiency of drug and medical device supervision and inspection. Strictly standardize administrative inspections involving enterprises; where possible, consolidate inspections to avoid duplication.Conduct combined inspections for manufacturers of Class II and Class III medical devices that also produce Class I medical devices; coordinate annual inspection plans so that inspections for the "Good Manufacturing Practice for Drugs/Medical Devices/Cosmetics" and the "Good Pharmacovigilance Practice" can be conducted simultaneously and in an orderly manner for enterprises that produce drugs, medical devices, and cosmetics; explore non-site inspection methods such as written verification and remote inspections to reduce inspection frequency and improve the quality and efficiency of inspections and services. (Responsibility: Provincial Drug Administration)

(10) Enhance the quality and efficiency of pharmaceutical distribution supervision. Accelerate the implementation of traceability for all drug varieties and across all stages of the supply chain; integrate drug traceability data from production, distribution, and use to achieve “one product, one code; trace both product and code”; and promote the integration and interoperability of health and medical insurance scanning information.Support the modernization and upgrading of logistics and warehousing facilities for pharmaceutical wholesalers, integrate warehousing and transportation resources, and encourage the use of outsourced storage and transportation services as well as multi-warehouse coordination. While fully ensuring drug safety, support the internal resource integration of pharmaceutical manufacturing and distribution enterprises within the same group to optimize the layout of pharmaceutical logistics networks and the allocation of transport capacity, thereby establishing an efficient logistics management model. (Responsibility lies with the Provincial Department of Commerce, Provincial Health Commission, Provincial Medical Insurance Bureau, and Provincial Drug Administration Bureau according to their respective duties)

(11) Promote digital empowerment of pharmaceutical enterprises. Promote the deep integration of information technology with the pharmaceutical industry chain and encourage pharmaceutical manufacturers and distributors to build digital and intelligent systems. Implement the "Technical Guidelines for Electronic Records in Vaccine Production and Testing (Trial)" and the "Three-Year Action Plan for Smart Supervision of Blood Product Production," with a focus on supporting vaccine and blood product manufacturers in establishing information management systems covering the entire production and testing process. (Responsibility to be shared by the Provincial Department of Industry and Information Technology, the Provincial Data Bureau, and the Provincial Drug Administration according to their respective duties)

IV. Strengthening Regulatory Capacity Building

(12) Improve the accountability and regulatory frameworks. Revise the "Yunnan Provincial Regulations on Drug Administration" to refine the provincial drug regulatory framework, implement joint responsibility for drug safety between Party and government authorities, and reinforce local management responsibilities for drug safety. Address regulatory challenges, potential risks, and weak links by further refining regulatory mechanisms to establish a closed-loop, full-chain regulatory system. (Responsibility lies with the Provincial Drug Administration and the Provincial Market Regulation Bureau according to their respective duties)

(13) Strengthen technical review capacity. Enhance the capacity of provincial-level medical device review agencies and reviewers, accelerate the expansion of specialized review categories, and achieve full coverage of products under development within the province. Expand the team of drug reviewers to meet the requirements of the pilot program for optimizing the review and approval procedures for supplemental drug applications. Continue to develop templates for submission documents and review guidelines to enhance the quality and efficiency of review work through mutual empowerment.(Responsibility lies with the Provincial Department of Human Resources and Social Security and the Provincial Drug Administration Bureau in accordance with their respective duties)

(14) Strengthen drug testing capabilities. Focusing on biological products and port inspection systems, accelerate the development of batch release capabilities for biological products, obtain new testing qualifications for blood products, and systematically expand the scope of authorized batch release varieties;continue to ensure that personnel, equipment, and information technology at provincial-level drug testing institutions gradually meet the national standards for port drug testing institutions, and strive to designate Kunming Changshui Airport as a drug import port by the end of the 15th Five-Year Plan; simultaneously optimize the management of imported medicinal materials, explore extending sampling and testing capabilities for imported medicinal materials to ports, and expand the import of high-quality medicinal materials from overseas. (Responsibility lies with the Provincial Development and Reform Commission, the Provincial Department of Industry and Information Technology, the Provincial Department of Commerce, and the Provincial Drug Administration Bureau according to their respective duties)

(15) Strengthen the capacity-building of medical device testing. Collaborate with experts from various fields, including universities, testing and inspection institutions, and medical institutions, to promote the establishment of the Yunnan Provincial Technical Committee for Medical Device Standardization. Establish a medical software testing laboratory, a laboratory for the quality and safety evaluation of pharmaceutical packaging systems, and a laboratory for the biosafety evaluation of medical devices.Expand testing qualifications for products in areas such as centrally procured medical devices, artificial intelligence, in vitro diagnostic reagents, and traditional Chinese medicine medical devices. Continue to ensure that personnel, equipment, and information technology infrastructure at provincial-level medical device testing institutions gradually meet the C-level laboratory standards outlined in the “Guiding Principles for Capacity Building of Medical Device Testing and Inspection Institutions.” (Responsibility lies with the Provincial Department of Industry and Information Technology, Provincial Department of Science and Technology, Provincial Department of Human Resources and Social Security, Provincial Market Regulation Bureau, and Provincial Drug Administration, in accordance with their respective duties)

(16) Strengthen the adverse reaction (event) monitoring system. Continue to consolidate the “one body, two wings” adverse reaction monitoring system, advance the standardized development of adverse drug reaction monitoring capabilities at the municipal and county levels, and strengthen the construction of national and provincial sentinel hospitals. The drug regulatory, health, disease control, and medical insurance departments shall coordinate efforts to strengthen the monitoring of adverse reactions (events) for key products such as innovative drugs and medical devices, products selected through centralized procurement, vaccines, blood products, traditional Chinese medicine injections, and medical institution preparations.(Responsibility lies with the Provincial Health Commission, Provincial Market Regulation Bureau, Provincial Medical Insurance Bureau, and Provincial Drug Administration Bureau according to their respective duties)

(17) Establish a smart regulatory system. Optimize and improve the administrative approval system; deepen the “one-stop online service + fully online processing” model; strengthen the application of electronic certificates (approval documents) and data sharing; and introduce AI technology to enhance service intelligence, ensuring that “information travels more so the public has to run less.”Improve the drug production supervision system and the drug and medical device record system. Establish a tiered and categorized supervision system through data integration and risk analysis, and build a regulatory model characterized by “no interference unless necessary, early warning for minor issues, and strict investigation for major issues.” Enhance the risk identification capabilities of the “Drug Supervision Insight” platform, and gradually incorporate high-risk products such as vaccines, blood products, and traditional Chinese medicine injections into the platform to achieve full-process supervision. (Responsibility: Provincial Drug Administration)

(18) Strengthen the development of the regulatory workforce. Increase efforts to attract and cultivate talent in the field of innovative drug and medical device regulation; streamline channels for professional title applications in the pharmaceutical regulatory sector; and actively support regulatory personnel in applying for programs such as the “Xingdian Talents Support Plan.”Strengthen the development of on-site inspectors, improve the system for on-site vaccine inspections, and enhance the regulatory capacity for vaccine products. Explore the establishment of pharmaceutical innovation service institutions in prefectures (cities) with concentrated pharmaceutical industries through a collaborative model between the province and local governments. (Responsibility lies with the people’s governments of all prefectures and cities, and the Provincial Drug Administration, in accordance with their respective duties)

(19) Intensify efforts to advance regulatory science. Focusing on the strategic needs of pharmaceutical innovation and regulatory science, establish regulatory science research bases under the National Medical Products Administration or at the provincial level to conduct research on new technologies, methods, and tools. Leveraging the province’s geographical characteristics, collaborate with local universities, research institutes, and medical institutions to explore the establishment of laboratories for additive manufacturing, ergonomics and reliability testing of medical electrical equipment in high-altitude regions, as well as public service platforms for medical device R&D and testing targeting South and Southeast Asia.(Responsibility lies with the Provincial Department of Industry and Information Technology, the Provincial Department of Science and Technology, the Provincial Department of Agriculture and Rural Affairs, the Provincial Health Commission, and the Provincial Drug Administration, in accordance with their respective duties)