To strengthen supervision of food, drugs, and catering hygiene, continuously improve public safety in diet and medication use, and promote social harmony and stability, this plan is formulated in accordance with the "Outline of the 11th Five-Year Plan for National Economic and Social Development of the People's Republic of China" and relevant policies and directives of the Party Central Committee and the State Council.
I. Guiding Principles and Basic Standards
(I) Guiding Principles.
Guided by Deng Xiaoping Theory and the important thought of the "Three Represents," we will earnestly implement the Scientific Outlook on Development, fully fulfill our responsibilities in social management and public services, strengthen infrastructure for food and drug supervision, improve technical standard systems, significantly enhance testing capabilities, innovate regulatory mechanisms, standardize regulatory practices, elevate supervisory capacity and effectiveness, ensure public safety in food consumption and medication use, and make our due contribution to building a moderately prosperous society in all respects and creating a harmonious socialist society.
(II) Basic Principles.
First, adhere to a people-centered approach and serve the overall situation. We must ensure public food and drug safety as the starting point and ultimate goal of all work, aligning regulatory efforts with economic and social development, the overarching goals of building a moderately prosperous society in all respects, and reforms in China's administrative management system.
Second, adhere to scientific regulation and innovate mechanisms. We must establish a scientific regulatory philosophy, strengthen the technical support system, enhance capabilities and standards for food and drug safety oversight, reform regulatory institutions, and build a new mechanism that aligns with China's national conditions and the requirements of the socialist market economy.
Third, maintain full-process supervision and administer affairs in accordance with the law. We must strengthen food and drug safety supervision through legal means, continue to improve relevant laws and regulations, enforce them strictly, standardize supervisory practices, and achieve dynamic, standardized, and effective oversight across all stages of the food and drug supply chain.
Fourth, adhere to comprehensive planning and resource integration. We must fully leverage existing resources, optimize their allocation, and maximize the contribution of all areas and stages of food and drug regulation. This will establish a collaborative, jointly-managed safety supervision mechanism for food and drugs, ensuring that available resources deliver maximum impact.
Fifth, strengthen grassroots efforts and reinforce foundational work. Prioritize strengthening the grassroots and foundational aspects of food and drug safety supervision by mobilizing sufficient funding, technology, and talent to support these areas, ensuring significant improvements in grassroots capacity and foundational stability.
II. Development Goals
After about five years of effort, the food and drug regulatory system and mechanisms have been progressively improved; the legal and regulatory framework is comprehensive; the quality of the regulatory workforce has been comprehensively enhanced, and the ability to govern according to law has further strengthened; infrastructure construction has been reinforced, technical equipment upgraded, and standards for food and drug safety and testing capabilities significantly advanced; production and operation order in the food and drug sector has markedly improved; illegal activities involving the production and sale of counterfeit or substandard food and drugs have been effectively curbed, and the number of food and drug safety incidents has substantially decreased.
(I) By the end of the 11th Five-Year Plan, a basic food safety assurance system will be established.
Coverage of food safety information monitoring reaches 90%.
The qualified rate of randomly sampled fresh agricultural products in wholesale markets, large-scale farmers' markets, and chain supermarkets in major cities reaches 95%.
— 100% of major food safety incidents are resolved;
Food recall coverage reached 80%.
The national special inspection coverage for food production enterprises reached 90%.
(2) By the end of the 11th Five-Year Plan, drug regulatory capabilities were significantly improved.
The coverage rate of the rural drug supervision network reached 100%, and the coverage rate of the rural drug supply network remained above 80%.
For independent full-item testing capability against existing national drug standards, provincial and port drug inspection institutions achieve 100%, while municipal (prefecture-level) drug inspection institutions achieve 80%.
National-level medical device inspection institutions achieve 100% inspection capability for designated products, while provincial-level institutions achieve over 95% capability for routine market products.
The coverage rate of drug supervision and sampling will increase from 30% to 80%.
III. Key Tasks
(I) Food Safety.
1. Strengthen food safety monitoring. Develop regional zoning for edible agricultural products. Establish a national system for environmental safety supervision of agricultural production areas, conduct systematic investigations into pollution levels in these areas, and implement quality and safety monitoring in key regions and typical production zones. Enhance quality and environmental safety management of agricultural inputs. Implement a national monitoring system for veterinary drug and pesticide residues in agricultural products, expanding routine food safety inspections from the current 37 cities to all major urban centers nationwide. Establish a monitoring system for raw grain contamination, carry out quality and hygiene assessments of raw grains, and build a network for monitoring grain quality and hygiene. Conduct risk assessments on non-food ingredients, systematically investigate their contamination status, establish a nationwide special inspection regime for mandatory standards on key foods, implement an electronic labeling management system, and standardize food recall supervision and enforcement procedures. Improve systems for spot checks and routine monitoring of food hygiene and quality, and establish direct reporting points for food quality monitoring. Upgrade the national monitoring network for food contaminants and foodborne diseases.
Column 1 Food Safety Monitoring
Environmental Monitoring and Surveillance: Strengthen environmental monitoring of "vegetable basket" bases in key cities nationwide, conduct zoning for agricultural product production site environmental safety and monitor major pollution sources in the Bohai Rim, Pearl River Delta, and Yangtze River Delta. Establish environmental monitoring stations for agricultural product production sites in key cities and build a national shared platform for the agricultural product production site environmental quality database.
Market Quality Monitoring and Supervision: Improve the routine market monitoring system by establishing fresh produce quality monitoring and supervision points at wholesale markets, large-scale farmers' markets, and chain supermarkets in major cities.
Food Contaminant and Foodborne Disease Surveillance: Strengthen the surveillance network with provinces (autonomous regions, municipalities) as monitoring units, under which city and county monitoring stations are established.
Base Construction: Establish demonstration bases for agricultural products and food based on a circular economy model. Accelerate the development of bases for pesticide-free (agricultural) products, Good Agricultural Practices (GAP), green foods, and organic foods.
Non-Food Raw Material Monitoring and Food Recalls
Establish a three-tier (provincial, municipal, county) monitoring network for non-food raw material contamination. Conduct risk monitoring of non-food raw materials in key regions, products, and substances. Implement food recalls for high-risk categories including meat products, dairy, beverages, grain-processed foods, and edible vegetable oils.
2. Improve food safety inspection and testing capabilities.
Integrate and leverage existing food testing resources, strictly manage laboratory qualifications, and establish a coordinated, efficient, and unified food safety testing system. Enable resource sharing to meet regulatory oversight needs across the entire food production, distribution, and consumption chain. Strive to bring national-level food safety testing capabilities up to international standards. Promote the socialization of testing institutions by actively encouraging and developing third-party testing agencies.
Column 2 Key Focus Areas for Food Safety Testing Capacity Building
Agricultural Product Quality and Safety Inspection and Testing: Building on existing resources, establish a National Agricultural Product Quality Standard and Detection Technology Research Center, specialized agricultural product quality inspection centers, regional inspection centers, provincial comprehensive agricultural product quality inspection centers, and county-level agricultural product testing stations.
Food Quality and Safety Testing: Strengthen the capacity for food quality and safety testing at the National Food Quality Supervision and Inspection Center, as well as at city and county-level product quality inspection agencies.
Food Contaminants and Foodborne Disease Detection: Promote detection technologies for common hazards in the catering industry, and improve rapid detection methods for 10 common chemical and biological contamination factors.
Rapid Testing: Gradually equip food safety supervision and administration departments with necessary rapid testing equipment and mobile testing vehicles as needed.
3. Improve food safety standards.
Strengthen efforts to formulate and revise food safety standards, establishing a unified and scientific food safety standard system. Accelerate the adoption of international and advanced foreign standards in China's food safety framework and actively participate in the formulation and revision of international standards. Develop actionable transitional or tiered standards tailored to China's specific conditions in food production, processing, and distribution.
Column 3: Key Focus Areas for Developing Food Safety Standards
Pollution Control Standards: Develop standards focused on environmental pollution control for production areas of grain crops, vegetables, livestock products, and aquatic products.
Food Safety Standards: Develop origin environment standards required for certification and supervision of pollution-free agricultural products, Good Agricultural Practices (GAP), organic foods, and green foods; establish standards for grains and major agricultural products; set standards for the rational use of pesticides and fertilizers; define biosafety standards for genetically modified organisms; create animal disease prevention and control standards. Complete the development and revision of approximately 500 standards covering pesticide residues, veterinary drug residues, limits and testing methods for harmful heavy metals; finalize standards for biological toxins and limits and testing methods for harmful microorganisms; develop and revise standards for nutritional labeling, hygiene requirements for food containers and packaging materials, basic hygiene standards and testing methods for food contaminants, product hygiene standards for food items, and hygiene standards for the use of food additives; establish storage and transportation safety standards related to fresh food cold chain logistics, including temperature controls and operating procedures.
Standardization Demonstration: Establish a national standardization demonstration system for the quality and safety of bulk fresh agricultural products, competitive agricultural products, and export agricultural products, along with national-level agricultural standardization demonstration zones.
4. Build a food safety information system.
Leverage existing information resources and infrastructure to establish a national food safety information platform, creating a four-tier (national, provincial, municipal, and county) food safety information network and a direct reporting system for key enterprises. Build a high-performance, easy-to-manage, and secure dynamic food safety database. Develop a national food safety basic information sharing system to enable collaborative work environments that support monitoring and analysis, information dissemination, event alerting, emergency response, food safety research, and public services. Accelerate the establishment of a unified food safety information release mechanism.
Column 4: Key Projects in Food Safety Information Construction
Food Safety Information Monitoring Network: Establish and improve the food safety information monitoring network, gradually forming a unified and scientific food safety information assessment and early warning system.
Electronic Supervision: Gradually establish an electronic supervision network for food production, processing, and circulation to enable digital oversight of operational conditions and product quality for food producers and distributors.
Food Safety Information Center: Built upon the food safety information network and by integrating existing resources, this center categorizes, filters, analyzes, and monitors food safety data. It also evaluates food safety conditions and issues early warnings.
5. Enhance technological support for food safety.
Conduct basic and high-level research on food safety, tackle key technical challenges, and build a platform for sharing foundational food safety research data while strengthening applied technology and strategic studies. Monitor international Codex Alimentarius standards, food safety regulatory measures in major trading countries, and WTO notifications under the SPS Agreement and TBT Agreement. Enhance food safety technical capabilities to establish an open, internationally aligned research system with independent innovation capacity. Strengthen food safety talent development and discipline construction.
Column 5: Key Focus Areas in Food Safety Technology Research
Tracking and research, including Codex Alimentarius, food safety management systems and policies of major trading countries, laws, regulations and standards, safety assurance technical measures, and key detection technologies.
Evaluation of Food Technology Research: Covers novel food ingredients, emerging technologies and processes, genetically modified foods, food additives, and food contact materials.
Food Safety Risk Assessment Research: Covers pathogenic microorganisms, pesticide and veterinary drug residues, new food resources, and chemical hazards (including biological toxins); establishes risk assessment models and methods for foodborne hazards; proposes high-risk food lists and control measures.
Applied Technology Research: Includes food variety traceability, food origin mapping, food origin labeling and barcode tracing, agricultural product quality and safety traceability, inspection and testing technologies, detection technologies for food processing and distribution, counterfeit food detection, rapid food safety testing, laboratory confirmation methods, testing standards and safety validation protocols, early warning systems for food safety emergencies, and food safety control research across production, processing, and transportation.
6. Strengthen the emergency response system for food safety incidents and major accidents.
Strengthen the food safety emergency response mechanism and implement a rapid-response linkage system. Enhance the emergency command and decision-making framework, monitoring, reporting, and early warning systems, technical support for emergency testing, emergency response teams and resource assurance systems, as well as training and drill bases and on-site response capabilities to improve government emergency handling capacity. Significantly increase oversight of major food safety incidents, refine investigation and accountability mechanisms, establish follow-up supervision and accountability systems for major food safety incidents, and progressively advance the national food safety inspectorate system.
Column 6: Key Points for Building a Food Safety Emergency System
Emergency Response and Handling: Gradually establish an integrated emergency response network platform for food safety incidents and major accidents, and strengthen the emergency command and decision-making system.
Rapid Response to Food Poisoning: Establish a reporting and complaint system for food poisoning in the catering industry, along with a rapid response and handling system, to enhance food poisoning management and traceability capabilities.
Rapid Response for Food Processing and Distribution: Establish an emergency response system for food production, processing, and distribution.
7. Establish a food safety assessment and evaluation system.
Gradually establish a food safety risk assessment and evaluation system to study potential hazards, their severity, and the probability of occurrence. Based on this analysis, classify foods into risk levels, using dynamic assessment results as the foundation for government food safety decision-making and management.
Column 7 Food Safety Evaluation
Survey and Evaluation: Assess the safety of livestock, poultry, fruits, vegetables, aquatic products, alcoholic beverages, dairy products, infant foods, grain and oil products, condiments, convenience foods, soybean products, drinking water, food additives, and food packaging materials. Also evaluate the establishment and implementation of corporate food safety supervision systems.
Risk Assessment: Conduct risk assessments on the hazards posed to food safety by pesticide and veterinary drug residues, toxic and harmful substance contamination, food additives, food packaging materials, and food processing technologies and equipment.
Key Food Special Inspections: Conduct nationwide special inspections annually on 15 categories of key foods and perform mandatory standard testing on products from processing and production enterprises, implemented through an annual rolling schedule.
8. Improve the food safety integrity system.
Strengthen food safety integrity awareness across society, foster an environment of integrity, and cultivate a culture of food safety trust. Establish a preliminary operational mechanism for food safety integrity to fully leverage the system's role in standardizing, guiding, and supervising food safety efforts. Gradually develop food safety integrity records for enterprises and implement classified supervision based on integrity levels. Enhance the "local governments bear overall responsibility for food safety, while enterprises are the primary responsible parties" framework, strengthen industry self-discipline, and establish a red-and-black list system for food companies.
Column 8 Food Safety Integrity
Food Safety Integrity-Based Classified Supervision: Establish an information system for registration files and a classified database of integrity for food production and operation entities. Collect comprehensive data on market entry, regulatory oversight, and consumer complaints/appeals to strengthen the integrity-based classified supervision framework.
Quantified Grading Management: Fully implement quantified grading management for food hygiene supervision, and strengthen food hygiene licensing and oversight.
9. Continue the special campaign on food safety.
Crack down on the production and sale of counterfeit or substandard food. Launch targeted campaigns to address high-risk food safety issues, raising safety standards for key items closely tied to daily life—including grains, meat, vegetables, fruits, dairy, soy products, and seafood—across critical stages such as farming, processing, distribution, and consumption. Strengthen regional food safety supervision accountability systems and enhance routine oversight of food enterprises. Explore effective regulatory models for small-scale rural food producers and sellers. Effectively curb illegal activities involving non-food ingredients, excessive use of additives, and unlicensed food production and sales. Intensify market supervision, continue rectifying and standardizing food advertising with a focus on small and medium-sized cities. Aligning with socialist new rural construction, comprehensively strengthen rural food safety oversight by guiding and conducting specialized rural food safety campaigns. Build modern rural food distribution networks, social monitoring networks, and responsibility-based supervision networks to significantly boost rural food safety protection capabilities.
Column 9 Food Safety Special Campaign
Rural Food Safety Special Initiative: Strengthen targeted campaigns against pesticide and veterinary drug residues in crop planting and animal husbandry, misuse of banned substances in livestock products, and drug residues in aquatic products. Gradually establish a comprehensive rural food safety supervision network. Develop and promote quality and safety control systems for small-scale food and agricultural product processing enterprises in rural areas. Conduct special rectification campaigns on food markets in rural areas and urban-rural fringe zones. Enhance supervision and management of small restaurants and group meals in rural areas, and establish a declaration guidance system.
Special Campaign for the Livestock and Poultry Slaughter Industry: Crack down on illegal slaughter and establish a safe disposal system for diseased meat.
Special Campaign to Rectify High-Risk Food Production and Processing Industries: Identify key high-risk foods annually, conduct comprehensive inspections and testing in production and processing sectors, and implement targeted rectification measures.
Label and Marking Management: Strengthen oversight of labels and markings on food, food additives, and food packaging materials.
Security Assurance: Delivered food safety security services for the 2008 Beijing Olympic Games and the 2010 Shanghai World Expo.
Demonstration Projects: Launch special campaigns to rectify food production and processing quality and safety, and implement demonstration programs for the supervision of small enterprises and workshops; establish a self-regulation system for the food market through demonstration initiatives; develop "Food Safety Supply Chain Demonstration Projects," cultivate "100 Trusted Meat Processing Plants," and create "100 Green Markets."
10. Complete food safety certifications.
Establish a unified national food certification system covering the entire "farm-to-table" process and improve its framework. Implement origin certification and product certification for agricultural goods, actively promote certifications for organic and green foods, and strengthen efforts in no-harmful agricultural products and animal feed quality certifications. Conduct management system certifications for producers of agricultural inputs, processors of agricultural products, and farming operations. Enhance Good Agricultural Practices (GAP), Good Manufacturing Practices (GMP), good storage and transportation standards, Hazard Analysis and Critical Control Points (HACCP), and green market certification to improve food enterprises' self-management capabilities. Accelerate international mutual recognition of China's food certification systems.
11. Strengthen food safety management for imports and exports.
Establish and improve the import food quality and safety access system, developing scientific, rational, and internationally aligned access procedures. Implement classified management based on food risk analysis to enhance the effectiveness of import food inspection and quarantine. Refine the import food inspection system, focusing on verifying pesticides and veterinary drugs, food additives, pathogenic microorganisms, toxic and harmful substances, and labeling and identification in food products. Establish and improve the "One Model, Ten Systems" export food safety management framework (including the "Company + Base + Standardization" management model and ten management systems such as registration and filing of planting and breeding bases). Fully leverage WTO rules under the Agreement on Technical Barriers to Trade (TBT) and the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) to build a comprehensive food safety technical trade measures system. Develop standards for controlling quality and safety in imported and exported foods, and formulate or revise industry standards for food inspection and quarantine related to testing methods.
Column 10: Key Points in Import and Export Food Safety Management
Strengthen the food safety quality management system for import and export. Conduct risk analysis to establish and improve quarantine and inspection access procedures and requirements for imported foods, and implement a food quality and safety monitoring plan for imports. Establish a monitoring system for infectious diseases and pesticide/veterinary drug residues in exported foods, and apply electronic supervision to food production and processing enterprises for export. Promote traceability and recall systems for exported food quality, build a risk prediction and rapid response framework, and publish red and black lists of compliant and non-compliant import/export food enterprises.
Enhance technical support for inspection and quarantine of imported and exported food by strengthening testing capabilities and expert teams, and improving the information system for food safety.
12. Conduct food safety publicity, education, and training.
Develop a framework for food safety education and public outreach. Strengthen communication on food safety laws, regulations, policies, and standards to disseminate foundational knowledge, raise public awareness, and empower consumers with self-protection skills and the ability to participate in oversight. Accelerate the development of a comprehensive food safety training system to deliver multi-format and multi-channel education for government officials, law enforcement personnel, enterprise managers and staff, journalists, and consumers.
Column 11 Food Safety Publicity, Education, and Training
Food Safety Awareness and Education: Launch initiatives such as "Food Safety in Rural Areas," "Food Safety in Communities," and "Food Safety on Campuses." Promote the concept of "Green Consumption" and educate the public on food safety knowledge.
Food Safety Supervision Personnel Enhancement Program: Provide essential food safety training to administrative law enforcement officers and technical professionals engaged in food safety supervision, strengthen food safety awareness, and improve regulatory capabilities.
Food Safety First Responsible Person Competency Enhancement Program: Strengthen training and education for food production and operation enterprises, their legal representatives, and responsible persons to enhance food safety awareness and improve food safety assurance capabilities.
(II) Drug Safety.
13. Enhance drug safety supervision capabilities.
(1) Establish a scientific drug evaluation system. Strengthen the regulatory framework for drug registration and develop technical guidelines for drug research and development. Integrate drug registration management resources, deepen reforms to the drug registration review mechanism, strictly enforce registration approval procedures, and build an efficient, cost-effective drug registration management system. Enhance process supervision of preclinical and clinical drug studies to ensure all non-clinical and clinical trials in China comply with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). Conduct research on drug evaluation methodologies, strengthen and standardize safety evaluation techniques for innovative and imported drugs, and encourage innovation in drug R&D. Reinforce drug standards management by implementing the "National Drug Standards Improvement Action Plan." Establish a scientific evaluation system for biotechnology products. Improve national standards for pharmaceutical excipients and packaging materials and containers that directly contact drugs. Build a comprehensive registration, testing, and evaluation system for health food products.
(2) Strengthen oversight of drug manufacturing quality. Further improve the certification system for Good Manufacturing Practice (GMP) for drugs, revise GMP standards, enhance implementation levels, and progressively align with international GMP practices used in developed countries. Reinforce dynamic monitoring of drug production to ensure product quality and promote healthy growth of the pharmaceutical industry. Implement Good Laboratory Practice (GLP) standards for compounding preparations in medical institutions. Strengthen source control of traditional Chinese medicine (TCM), refine the management system for implementing Good Agricultural and Collection Practices (GACP) for TCM, and enforce GACP to ensure the quality of TCM raw materials. Enhance regulatory oversight of medicinal excipients and packaging materials and containers that come into direct contact with drugs.
Strengthen the post-marketing drug supervision system. Enhance the adverse reaction monitoring network, standardize reporting systems and responsibilities for adverse drug reactions (ADRs), and implement the "Drug Re-evaluation Management Measures." Develop supporting technical specifications and guidelines to conduct phased re-evaluation studies on marketed drugs. Establish a long-term risk management mechanism covering monitoring, early warning, emergency response, market withdrawal, and phase-out of post-marketing drugs. Strengthen ADR monitoring institutions, improve the overall ADR monitoring system, and enhance capabilities at municipal and county levels. Further refine the prescription and over-the-counter (OTC) drug classification management system. Align with healthcare reform initiatives to fully implement OTC/prescription classification, advance related legislation, and standardize drug packaging and labeling. Revise certification standards for Good Distribution Practice (GDP), update GDP certification management procedures and follow-up inspection protocols, and implement the "Drug Circulation Supervision and Management Measures" to promote modern logistics development. Establish and improve drug abuse monitoring networks and special drug supervision systems to track every dose and unit of special controlled substances. Set up monitoring, reporting, and early warning systems for diversion and abuse incidents involving narcotic and psychotropic drugs. Refine evaluation methods and criteria for assessing the dependency potential and abuse liability of these substances.
(4) Strengthen the drug inspection system. Standardize the functions of drug inspection agencies at all levels, optimize resource allocation, and advance research on testing methods. Build a technical platform for the drug inspection system and promote rapid testing technologies. Establish and enhance a national information management and data exchange system for drug technical inspections. Improve the drug inspection regime that integrates sample submission, random sampling, and batch-by-batch testing. Reform the supervision and sampling mechanism to increase the efficiency of funding utilization.
(5) Establish a comprehensive standardization system and technical evaluation framework for traditional Chinese medicine (TCM). Develop a TCM management classification system, along with corresponding management regulations and technical evaluation standards. Research and build a basic framework for TCM standards and technical evaluation that reflects China's unique characteristics and aligns with TCM principles. Formulate和完善 standards for medicinal materials, processed herbal pieces, and patent medicines; establish technical specifications for the collection, propagation, and identification of authentic regional varieties of medicinal materials. Further refine standards and norms throughout the production and processing of medicinal materials, herbal pieces, and patent medicines. Create a quality assurance system for authentic regional varieties. Define pre-market technical review standards and post-market re-evaluation standards for TCM products. Issue guidelines for research on reference substances and establish a national repository of TCM reference substances. Strengthen support and regulatory oversight for ethnic medicines. Actively promote the establishment of an international coordination mechanism for traditional medicines.
Column 12 – Drug Regulation
National Drug Standard Improvement Action Plan: Complete the standard improvement for 4000 proprietary Chinese medicines, 500 chemical drugs, and 300 early-stage new drugs transitioning to national standards; establish standards for 223 common pharmaceutical excipients; and finalize the formulation or revision of national standards for 1000 traditional Chinese medicinal materials and 500 Chinese herbal decoction pieces.
Key Initiative for Post-Marketing Drug Evaluation: Establish a post-marketing drug evaluation database and information exchange platform to provide safety information on approved drugs, with a focus on conducting re-evaluations of key products such as Chinese medicine injections.
Innovation and Talent Development Program
Advance innovation projects focused on biotechnology products, standardization of Traditional Chinese Medicine quality, tissue engineering and stem cell medical products with quality control standards, new safety evaluation technologies and models, and testing technology research. Develop a distance education system to deliver training in pharmaceutical and medical device management, technology, and professional skills, completing demonstration training for leaders at provincial, municipal, and county-level drug regulatory agencies.
14. Standardize medical device safety supervision.
(1) Establish and improve the regulatory framework for medical devices. Enhance the medical device regulatory system by timely revising the "Regulations on the Supervision and Administration of Medical Devices" and formulating the "Measures for the Supervision and Administration of Medical Device Circulation." Additionally, develop and revise regulations including the "Measures for Medical Device Registration," "Measures for In Vitro Diagnostic Reagent Registration," "Measures for Medical Device Standards," "Medical Device Classification Catalog," and "Provisions on Clinical Trials of Medical Devices."
Strengthen the medical device standards system. Improve the medical device standards framework by formulating and revising 500 national and industry standards; enhance cooperation with international standardization organizations to increase the adoption rate of international standards; establish a working mechanism for the development and experimental verification of reference materials related to medical devices.
Strengthen the capacity of medical device testing systems, including national and provincial capabilities. Leverage social resources to expand accreditation for testing institutions; enhance testing capabilities for electrical safety, electromagnetic compatibility, and biological safety of medical devices; and increase scrutiny of high-risk devices. Establish a mechanism and framework for supervisory and evaluative sampling, broaden the scope of tests conducted, standardize sampling practices, and intensify inspection efforts.
Strengthen the system for medical device review and approval. Establish and improve national and provincial medical device technical review systems, form a team of review experts, and build an information communication platform for technical reviews; develop unified technical review standards; regulate medical device registration and approval processes. Strictly enforce preclinical research requirements for new and high-risk medical devices. Improve clinical trial institutions for medical devices and conduct qualification assessments based on professional standards. Implement clinical approval systems for new and high-risk medical devices.
Strengthen the management of medical device quality systems. Formulate and implement in phases the general principles for medical device quality system management specifications, along with implementation guidelines for sterile devices, implantable devices, active devices, passive devices, non-contact active devices, and in vitro diagnostic reagents, as well as inspector work guidelines. Conduct training on these quality system management specifications to strengthen the inspector workforce. Gradually inspect second- and third-class medical device manufacturers against these specifications to ensure compliance.
Strengthen the monitoring and re-evaluation system for adverse events related to medical devices (6). Implement the "Administrative Measures for Monitoring and Re-evaluation of Adverse Events Related to Medical Devices" and the "Administrative Measures for Recall of Medical Devices," develop corresponding technical guidelines and operational standards, establish a robust reporting framework, and reinforce enterprise responsibilities and obligations. Build a technical platform for post-market risk-benefit evaluation of medical devices and implement systems for early warning and recalls.
(7) Strengthen oversight of medical devices in use. Conduct research on these devices and establish regulatory frameworks. Advance technical studies on device lifespan and scrapping criteria, develop evaluation methods for monitoring devices in use, and improve regulatory efficiency.
Column 13 Medical Device Regulation
The adoption rate of international standards for medical devices is 80%. A total of 200 standards for medical electrical equipment, 200 for medical non-active products, and 100 for diagnostic reagents have been completed. Work on formulating and revising fundamental standards, including the General Safety Standard for Medical Electrical Equipment (4th Edition) and electromagnetic compatibility, has been finalized.
Medical Device Testing System Capability Enhancement Project: Strengthen the construction of national medical device biological performance testing laboratories and improve the medical device testing system.
15. Strengthen market supervision of drugs and medical devices.
(1) Crack down severely on the manufacture and sale of counterfeit or substandard drugs and medical devices. Concentrate efforts to investigate and penalize major cases involving widespread impact, significant public concern, and severe consequences related to fake or inferior drugs and devices. For cases constituting crimes, promptly transfer them to judicial authorities for criminal liability. Strengthen supervision of Chinese herbal medicine professional markets, raw herbs, and processed Chinese medicinal slices, and thoroughly rectify and standardize their market circulation order.
(2) Continue rectifying and standardizing advertising for drugs and medical devices. Strengthen the quality of the advertising approval team, strictly review advertising content according to standards, establish an advertising monitoring network, and increase monitoring efforts. Promote laws and regulations related to drug and medical device advertising management to enhance the public's ability to identify illegal advertisements and actively leverage social supervision. Guide advertisers, advertising operators, and publishers to legally and compliantly release advertisements, blocking channels for illegal dissemination. Strictly investigate and punish drug and medical device production and operation enterprises that seriously violate advertising laws. Gradually establish a comprehensive governance mechanism.
(3) Advance the integrity system for drugs and medical devices. Improve classified management of drug integrity and establish a comprehensive integrity archive system for administrative counterparts; implement an integrity management system for medical device manufacturers, strengthen the quality integrity evaluation framework and information disclosure mechanisms, develop integrity supervision archives for manufacturers, and preliminarily establish an operational mechanism for medical device integrity; create "reputation archives" for experts and internal departments involved in drug and medical device product review, enterprise approval, and certification inspections.
(4) Deepen the construction of rural drug supervision and supply networks. Summarize experiences, establish sound operating mechanisms, and integrate network development with building a new socialist countryside, particularly by establishing a new rural cooperative medical system. Formulate guidance policies and regulatory measures that align with rural drug supply realities; encourage and guide the development of modern logistics-oriented drug supply networks; support and instruct grassroots rural medical institutions in self-procurement, cultivation, and use of Chinese herbal medicines; ensure safe, effective, convenient, and timely access to medicines for farmers.
Column 14: Rural Drug Safety Supervision
Rural Drug Supervision and Supply Network Construction: Through policy guidance, encourage and support legitimate pharmaceutical enterprises to consolidate distribution into townships and villages, and establish rural pharmacies that meet regulatory requirements. Support rural supervisors and information officers to strengthen drug supervision in rural areas, educate farmers on basic medication knowledge, and build a "well-functioning and effectively supervised" rural drug supervision and supply network. Ensure rural medication safety by regulating the sourcing, distribution, and usage of drugs, achieving a 100% coverage rate for the rural drug supervision network and a 80% coverage rate for the supply network.
16. Strengthen emergency response capabilities for sudden mass adverse events involving drugs and medical devices.
Strengthen the monitoring and early warning network for sudden, mass adverse events involving drugs and medical devices to enhance coordination, command, and rapid response capabilities. Boost emergency testing capacity at drug and medical device inspection agencies in key regions. Adhere to the principle of local and就近 handling to reinforce the harmless disposal of counterfeit and substandard drugs and medical devices. Actively explore a compensation system for drug-induced injury incidents.
Column 15: Emergency Capacity Building for Drug and Medical Device Safety
Key Focus of Emergency Preparedness: Strengthen the national-level training and drill bases for emergency response to adverse drug reactions and medical device incidents. Enhance the capabilities of emergency teams by equipping them with necessary emergency response gear, providing training in emergency knowledge and skills, and conducting regular drills to improve overall emergency response capacity.
17. Advance the informatization of drug and medical device regulation.
Implement the "3511" initiative to promote connectivity and information sharing, enable cross-departmental business collaboration, and enhance regulatory efficiency and effectiveness. Accelerate the development of core systems for drug and medical device registration, review, enterprise certification, and enforcement. Expand and improve public service systems, speed up transparency initiatives in drug and medical device regulation, and continuously elevate service quality for enterprises and the public.
Column 16: Digitalization of Drug and Medical Device Regulation
The "3511" project leverages the existing national unified government network to establish and improve a three-tier (national, provincial, and municipal) drug regulatory information system. Building on integrated resources, it establishes three platforms (information infrastructure platform, information security platform, application support platform), five application systems (administrative access management system, comprehensive law enforcement management system, major incident rapid response system, drug and medical device inspection and testing system, public service system), one center (drug regulatory information resource center), and one standard system (standardization system for construction of drug regulatory information).
18. Improve infrastructure for drug and medical device regulation.
Coordinate planning to improve the office and equipment conditions of administrative law enforcement agencies. Construct office and business facilities, equip necessary law enforcement tools, and within approximately five years ensure that office/business facilities and law enforcement equipment adequately meet operational needs; economically advanced regions may adopt a slightly ahead-of-schedule approach. Consolidate existing inspection and testing resources with rational layout, enhance laboratory conditions, equip instruments and devices, and comprehensively elevate the hardware capabilities for technical support.
Column 17: Infrastructure for Drug and Medical Device Regulation
Infrastructure Construction Projects: Strengthen the construction of office and business facilities for local food and drug regulatory law enforcement agencies; upgrade provincial and municipal drug testing institutions with basic law enforcement equipment and instruments; renovate national port drug testing institutions and national medical device testing institutions; continue to enhance the drug adverse reaction monitoring network; and implement the relocation project of the National Institutes for Food and Drug Control.
4. Safeguards
(I) Establish a scientific regulatory philosophy and innovate regulatory systems and mechanisms.
Implement the scientific development concept and, in line with specific requirements for reforming the national administrative management system, actively explore and innovate regulatory systems and mechanisms. In food safety supervision, strengthen institutional construction, clarify the responsibilities of relevant regulatory departments, and progressively establish a clear, efficient regulatory framework aligned with the scientific development concept. This will prevent overlapping functions among enforcement agencies and fragmented enforcement, eliminate regulatory gaps, enhance comprehensive enforcement, and promote joint enforcement by relevant departments. Continuously explore, innovate, and refine the food safety regulatory system to gradually establish a long-term mechanism for food safety oversight. For drug regulation, advance institutional reform to improve centralized decision-making, unified coordination, and regional regulatory mechanisms; enhance drug approval and sampling inspection processes; deepen reforms in administrative law enforcement, standardize enforcement practices, innovate hierarchical supervision mechanisms, and ensure effective enforcement. Tackle emerging challenges during development to elevate regulatory capabilities and standards.
(II) Strengthen the safety responsibility system and enhance corporate accountability.
Establish and improve the food and drug safety responsibility system in accordance with the principle that "local governments assume overall responsibility, regulatory departments fulfill their respective duties, and enterprises serve as the primary responsible parties." Local governments must strengthen leadership and organization, regularly analyze and assess local food and drug safety conditions, formulate regulatory measures, enhance supervision and inspection, and effectively handle food and drug safety incidents. All departments should cooperate closely, ensure seamless coordination, and establish a complete regulatory chain.
Production and operation enterprises must strengthen self-discipline and accountability, establish robust responsibility and self-regulation systems, improve internal management, enhance corporate integrity, and actively fulfill their safety responsibilities for food and drugs.
(3) Strengthen the legal framework and advance law-based governance.
Advance the formulation and revision of food hygiene laws as appropriate, implement the "Law of the People's Republic of China on the Quality and Safety of Agricultural Products," and establish a comprehensive legal framework for food safety. Strictly enforce the "Drug Administration Law of the People's Republic of China" and its implementing regulations, laying the foundation for a complete legal system covering drug and food safety during the 11th Five-Year Plan period. Deepen reforms in administrative approval systems by innovating approval methods, standardizing procedures, and promoting government transparency. Establish hearing and expert review mechanisms for major decisions in food and drug regulation. Strengthen administrative reconsideration work. Innovate supervision mechanisms for law enforcement, enhance oversight, implement accountability systems, and improve regulatory efficiency. Intensive training on laws and regulations for grassroots enforcement teams to elevate overall professional competence and capacity for administration by law.
(4) Increase government investment and provide necessary fiscal support.
Governments at all levels should increase investment. All proposed planning projects must be grounded in reality, adhering to the principles of seeking truth from facts and acting within available means. Based on fully leveraging and rationally allocating existing resources, governments should provide necessary support and financial guarantees to strengthen food and drug safety infrastructure, enhance regulatory capabilities, and ensure smooth enforcement operations.
(5) Leverage social oversight to foster a positive public discourse environment.
Leverage the positive role of industry associations, academic societies, and intermediary organizations in building integrity, self-regulation, and advancing food and drug safety. Encourage the formation of specialized food and drug safety organizations to provide expert policy advice. Strengthen public education on food and drug safety laws and regulations, promote positive media coverage, and timely release food and drug safety information to boost consumer confidence and guide purchasing decisions. Encourage media outlets to conduct lawful public oversight, creating favorable conditions for government regulation. Empower consumers to play an active supervisory role by improving complaint reporting channels, establishing a market circulation supervision system with public participation, and strengthening communication mechanisms between the government and consumers in the food and drug safety sector.
(VI) Strengthen international cooperation and exchange to enhance regulatory capabilities.
Promote China's laws, regulations, and policies on food and drug safety through international exchanges and government-to-government cooperation. Expand the global influence of our regulatory work and enhance China's standing in the international community. Improve the professional capabilities and international readiness of civil servants through diverse engagement channels. Actively participate in relevant World Trade Organization activities to strengthen international cooperation and consultation mechanisms on food and drug safety. Maintain and deepen collaboration with related international organizations, developed countries' regulatory authorities, and technical institutions. Learn from advanced regulatory concepts and models, scientific standards frameworks, cutting-edge testing and inspection methods, and effective safety management practices to continuously elevate China's food and drug safety oversight.
(VII) Establish a planning implementation mechanism to ensure the achievement of planning objectives.
This plan serves as the guiding framework for national food and drug safety supervision during the 11th Five-Year Plan period. Its successful implementation demonstrates the government's commitment to fulfilling its duties. The food and drug regulatory agency is responsible for overall coordination, while other departments execute their assigned tasks within their respective scopes of responsibility. During implementation, relevant departments must strengthen leadership, balance immediate needs with long-term goals, advance comprehensively, and achieve key breakthroughs. Additionally, they should break down the plan's objectives and tasks into actionable items, align them closely with annual work schedules, set clear requirements, and implement specific measures. Regular monitoring, evaluation, and timely adjustments to the plan are essential to ensure seamless execution and full implementation.