Implement the national drug standard improvement action plan. With reference to international standards, priority should be given to improving the quality standards of essential drugs and high-risk drugs. Improve the quality standards and processing specifications of traditional Chinese medicines (materials) and ethnic medicines (materials). Drug production must strictly implement national standards, and those that do not meet the national standards shall not be produced, sold or used. Strengthen the study of national drug standards, focusing on safety indicators.
Implement the national medical device standard improvement action plan. Give priority to improving the basic general standards of medical devices, and improve the standards of high-risk products and products with large market use. Strengthen the research on testing technology and methods of medical devices, and enhance the scientific nature of standards. Accelerate the research of medical device reference materials and the construction of reference measurement laboratories.
Comprehensively improve the quality of generic drugs. The quality consistency of generic drugs approved before the implementation of the revised Measures for the Administration of Drug Registration in 2007 was evaluated with the same batch of generic drugs. Generic drugs listed in the national essential drugs list and commonly used in clinic completed before 20 15. If the quality consistency evaluation is unqualified, it will no longer be registered and its drug approval number will be revoked. Pharmaceutical manufacturing enterprises must, in accordance with the requirements of the Measures for the Administration of Drug Registration, conduct a comprehensive comparative study of the generic drugs they produce and the generic drugs they are producing as the basis for applying for re-registration.
Improve the national drug standard management system with People's Republic of China (PRC) Pharmacopoeia as the core. Formulate and revise the Measures for the Administration of Drug and Medical Device Standards, improve the procedures for the formulation, revision, release, implementation and abolition of drug and medical device standards, and establish a standard evaluation and elimination mechanism. Strengthen the construction of medical device standard management institutions. Establish a standard improvement mechanism led by the government, enterprises, inspection institutions, universities and scientific research institutions, and guide and encourage enterprises to improve quality standards through technological progress. Box 1: National Action Plan for Improving Drug and Medical Device Standards: Improve 6,500 drug standards, including 2,500 chemicals, 2,800 Chinese patent medicines, 200 biological products, 350 Chinese herbal medicines and 650 Chinese herbal pieces. Improve 139 packaging material standard for direct contact drugs, and formulate 100 packaging material standard for commonly used direct contact drugs. Improve the 132 standard for pharmaceutical excipients and formulate 200 standards for pharmaceutical excipients.
Improve medical device standards: 150 medical electrical equipment standards, 250 passive medical device product standards and 100 diagnostic reagent product standards have been completed. Complete the preparation (revision) of general safety standards (third edition) and electromagnetic compatibility standards for medical electrical equipment. Improve the research mechanism of reference materials and develop 15 reference materials for medical devices. (two) to strengthen the supervision of the whole process of drug quality.
Strict supervision of drug development. Improve drug development standards, formulate and revise technical guidelines and data management standards for drug development, and promote international mutual recognition of data. Establish and improve the supervision and inspection system and supervision mechanism of drug non-clinical safety evaluation laboratories and drug clinical trial institutions, and explore the establishment of hierarchical supervision and management system. Improve the coverage of on-site inspection of drug clinical trials and strengthen the safety data monitoring of drug clinical trials. All non-clinical research data of new drug applications must come from institutions that meet the quality management standards for drug non-clinical research. Encourage the development of drugs for rare diseases and dosage forms suitable for children. Strengthen the protection of subjects and improve the level of social participation and risk management in drug clinical trials. Strengthen the management of clinical trials of medical devices and formulate quality management standards. Strengthen the formulation of guiding principles for technical review of medical device product registration, unify the standards for medical device review, and improve the review ability.
Strict supervision of drug production. Strengthen the construction of drug production supervision system, focus on promoting the certification of production quality management norms, and establish and improve the drug production risk supervision system. Encourage research on standardized production technology of commonly used Chinese herbal medicines, promote the implementation of quality management standards for Chinese herbal medicine production, and encourage Chinese herbal medicine production enterprises to establish medicinal materials bases as required. Improve the quality management system of medical devices, and compile the implementation guidelines for quality management norms of key varieties of medical devices. Strengthen the regular inspection of the implementation of production quality management standards by pharmaceutical and medical device manufacturers, and severely investigate and deal with illegal enterprises. Strengthen the supervision of imported drugs, establish and improve the overseas inspection mechanism and norms, explore the establishment of export drug supervision system, promote the construction of drug import and export and customs online verification system, and establish and improve the classification management, entry-exit verification and risk management system of import and export medical devices.
Strictly supervise the circulation of drugs. Improve the drug business license system and the drug business quality management standard certification system. Improve the drug circulation system, standardize the circulation order, encourage drug production enterprises to directly distribute and directly settle accounts with drug retail institutions. Develop modern drug logistics and chain operation, and formulate relevant standards for drug cold chain logistics. Explore the establishment of a traceability system for the circulation of Chinese herbal medicines. Formulate and implement high-risk medical device management quality management standards, improve the entry threshold of medical device management enterprises, and improve the exit mechanism. Improve the supply network of essential drugs in rural areas, establish and improve the coordination mechanism for the supply of shortage drugs, and ensure the quality, safety, fairness and accessibility of essential drugs and shortage drugs.
Strictly supervise the use of drugs. Improve the quality management system of drug use, strengthen the quality management of drugs in medical institutions and retail pharmacies, give play to the guiding role of licensed pharmacists, standardize doctors' prescription behavior, and effectively reduce irrational drug use. Strengthen the supervision of medical devices in use and improve the management system of medical devices in use. Carry out drug safety publicity and education activities, popularize drug safety knowledge, raise public awareness of safe drug use, and promote rational drug use.
(3) Improve the drug inspection and testing system.
Improve the working mechanism of drug sampling, expand the coverage and variety of sampling, and increase the frequency of sampling. The sampling inspection of drugs must disclose the inspection standards and procedures, and publish the inspection results in time. Unqualified products shall be disposed of in time according to law.
Improve the ability of drug inspection. By the end of the Twelfth Five-Year Plan, provincial drug inspection institutions and port drug inspection institutions have the ability to inspect all chemicals and traditional Chinese medicines according to legal standards, and municipal drug inspection institutions have the ability to inspect more than 85% of the projects. Strengthen the inspection ability of biological products batch issuance, and authorize some provincial drug inspection institutions to undertake the task of biological products batch issuance. Authorized institutions must have the independent inspection ability of authorized varieties. Carry out research on key drug inspection technology, rapid drug inspection technology and supplementary inspection technology, and build a platform for enjoying inspection technology.
Improve the detection ability of medical devices, focusing on improving the detection ability and electrical safety, electromagnetic compatibility and biological safety of high-risk products such as implantable medical devices. Strengthen the recognition, supervision and evaluation of medical device testing institutions and establish an exit mechanism. By the end of the Twelfth Five-Year Plan, national medical device testing institutions have the ability to test all concentrated products, and provincial medical device testing institutions have the ability to test more than 95% of commonly used medical devices.
(four) to improve the level of drug safety monitoring and early warning.
Strengthen the monitoring of adverse drug reactions at the grass-roots level, improve the monitoring mechanism combining key monitoring with daily monitoring, and strengthen the evaluation and early warning of adverse drug reactions and medical device adverse events. Improve the drug safety news release system, timely release of drug safety early warning information.
Strengthen the monitoring of special drug abuse. Improve the monitoring network and system, establish a drug investigation and monitoring mechanism for sensitive people, and provide technical services and guarantees for the supervision of special drugs.
Improve the post-marketing re-evaluation system of drugs. Carry out drug safety risk analysis and evaluation, focusing on strengthening the safety evaluation of essential drugs, traditional Chinese medicine injections and high-risk drugs. Improve the technical support system for drug reevaluation. After re-evaluation, it is found that drugs with uncertain curative effect, serious adverse reactions and greater risks than clinical benefits that endanger public health will be cancelled. Establish a re-evaluation system for medical devices and organize re-evaluation of high-risk medical devices. Box 2: Adverse drug reaction monitoring and safety re-evaluation after drug marketing Monitoring and re-evaluation of engineering medical device adverse events: select 100 varieties, carry out key monitoring, formulate monitoring technical specifications, and complete post-marketing safety risk analysis report.
Improve the monitoring institutions of drugs and medical devices: strengthen the construction of monitoring institutions at the city and county levels. The reporting rate of ADR cases in counties (cities, districts) reached more than 80%, and the number of ADR reports reached 4 million/10,000. The reporting rate of medical device adverse events in counties (cities, districts) reached more than 70%, and the number of medical device adverse events reported reached 100/ 10,000. (five) severely crack down on the manufacture and sale of counterfeit and inferior drugs according to law.
Carry out in-depth special rectification of drug safety. We will improve the system of inter-ministerial coordination and joint meeting to crack down on the manufacture and sale of counterfeit drugs, improve the cooperation mechanism of anti-counterfeiting departments, and accelerate the construction of an information platform linking administrative law enforcement with criminal justice. Improve the mechanism of drug inspection and identification, and improve the timeliness of inspection and identification of counterfeit and inferior drugs. Strengthen administrative law enforcement supervision, standardize law enforcement behavior, and revoke the approval documents of production and operation enterprises that manufacture and sell counterfeit and inferior drugs according to law. We will improve the system of joint listing and supervision of cases, intensify the investigation and handling of cases, focus on cracking down on illegal and criminal activities of producing and selling counterfeit and inferior drugs by means of the Internet, mail and links, and resolutely crack down on illegal and criminal activities of importing and exporting counterfeit and inferior drugs. Study and solve the problem of low conviction and sentencing for producing and selling fake and inferior drugs, and increase the punishment for illegal and criminal acts of producing and selling fake and inferior drugs. Focusing on townships (towns) and villages, we will intensify grassroots anti-counterfeiting efforts and severely crack down on mobile drug dealers. Standardize the border trade of medicinal materials.
Severely crack down on advertising illegal drugs. Strictly examine and approve advertisements, improve the advertising monitoring network, and strengthen the normative guidance before the advertisement is released, the dynamic supervision during the release, and the investigation and punishment according to law after the release. Standardize online drug information services and advertising behavior, focusing on cracking down on the use of the Internet to publish false advertisements and false propaganda. Strengthen the supervision of drug e-commerce, especially the online drug retail market, strictly examine and approve the qualifications of Internet drug trading service websites, and promote the healthy development of Internet drug trading services.
(six) improve the drug safety emergency disposal system.
Improve emergency plans for drugs and medical devices, and standardize disposal procedures. Strengthen the construction of emergency platform, emergency inspection and other technical support systems, strengthen the construction of the national drug safety emergency drill base and the complaint reporting center of the US Food and Drug Administration, strengthen emergency management training, and improve the ability and level of emergency response. Improve the reporting and approval mechanism for the expansion and transformation of emergency drugs in major emergencies to ensure the timely and effective supply of emergency drugs. Box 3: Construction of emergency drill base for emergency management system construction project: Strengthen the construction of national emergency drill base for medicines and medical devices, carry out emergency knowledge and skills training, and organize emergency drills.
Equipped with emergency equipment: equipped with necessary emergency equipment for national and provincial emergency teams. (seven) to strengthen the construction of drug supervision infrastructure.
Accelerate the implementation of drug safety infrastructure construction projects, strengthen infrastructure construction such as technical review, inspection and certification, monitoring and early warning, further improve the laboratory conditions of national, provincial and municipal drug inspection institutions, and strengthen the infrastructure construction of provincial medical device testing centers. According to the standard, the office building of drug administrative supervision institutions shall be built, equipped with law enforcement equipment. Accelerate the application of rapid drug inspection technology at the grassroots level and configure rapid inspection equipment. Box 4: Strengthening the infrastructure construction of drug safety infrastructure construction project: strengthening the construction of business premises of drug administrative supervision institutions, improving the laboratory conditions of national, provincial (including ports) and municipal drug inspection institutions, equipping them with inspection equipment, and enhancing the rapid inspection capacity of grass-roots units. Infrastructure construction of provincial medical device testing institutions and municipal adverse drug reaction monitoring institutions.
Strengthen law enforcement equipment: according to the equipment standard, equip the drug administrative supervision institutions at the city and county levels with necessary law enforcement equipment. (eight) to speed up the construction of supervision information.
Promote the construction of the national drug electronic supervision system, and improve the drug electronic supervision system covering all varieties, whole processes and traceability. Integrate information resources, unify information standards, improve * * *, and gradually realize the docking of the national drug electronic supervision system with relevant departments and enterprise information systems. Take information technology to realize off-site supervision of drug R&D and production process. Establish and improve the medical device supervision information system, and start the national unified coding of high-risk medical devices. Complete the first phase of the national drug supervision information system and start the second phase. Box 5: Construction of the application platform of the second phase project of the national drug supervision information system: expand five application platforms, including administrative law enforcement, monitoring and analysis, open government affairs, social emergency and internal management, build a data center, and increase an auxiliary decision-making information platform.
Information system construction: establish information systems for drug non-clinical research, drug clinical trials and drug production quality management, and carry out advertising supervision, rational drug use supervision in medical institutions, drug safety evaluation and medical device supervision pilot projects.
Security construction of information resources: improve the information resources guarantee and supporting environment construction of drug supervision. (9) Improve the quality of the talent team.
Formulate medium and long-term talent development plans for drug supervision, and establish strict personnel access, training and management systems. Strengthen the training of professional and technical personnel in drug supervision departments, speed up the training of high-level supervision talents and urgently needed specialized talents, and form a professional team of drug supervision with moderate scale, reasonable structure and excellent quality. Build the National Advanced Training Institute of the US Food and Drug Administration, gradually form a national and provincial training framework, and build a network education and training platform covering the whole system. Strengthen the training of grassroots leading cadres and top leaders of drug supervision departments and improve the supervision level. By the end of the "Twelfth Five-Year Plan", more than 75% of drug supervision teams at all levels have bachelor degree or above, and more than 75% have related professionals in pharmacy, medical devices, medicine and law. Box 6: Improve the quality of talent team. Talent Team Foundation Project: Strengthen the infrastructure construction of the National Institute of Advanced Studies of the US Food and Drug Administration. Confirm qualified institutions in batches as the cadre education and training base of the national food and drug supervision system. Construct the discipline, curriculum, teachers and network training system of drug supervision.
Professional and technical personnel training program: strengthen technical review, inspection and certification, inspection and testing, monitoring and early warning, emergency management, policy research team building and personnel training, and complete a new round of national-level rotation training for the main leaders of provincial and municipal technical support institutions.
Training program for administrative supervisors: complete a new round of national-level rotation training for members of the leadership team of provincial food and drug regulatory agencies and the main heads of municipal and county administrative regulatory agencies.