National Health Commission Confirms Launch of Pharmaceutical Use Monitoring and Clinical Comprehensive Evaluation with Information Systems as Core Management Tools

NHC Drug Administration Letter [2019] No. 80

To the Health Commissions of all provinces, autonomous regions, municipalities directly under the Central Government, and the Xinjiang Production and Construction Corps; to the Center for Management of Pharmaceutical and Contraceptive Supplies, the Center for Statistical Information, the National Health Development Research Center (National Center for Comprehensive Assessment of Drugs and Health Technologies), the National Center for Cardiovascular Diseases, and the National Cancer Center:

To implement the decisions and plans of the CPC Central Committee and the State Council on improving the drug supply guarantee system, to timely and accurately grasp drug usage patterns, to continuously enhance the standardized and scientific management of drug use, and to better safeguard public health, the following notice is hereby issued regarding matters related to carrying out drug use monitoring and clinical comprehensive evaluation:

I. Fully Recognize the Importance of Drug Use Monitoring and Comprehensive Clinical Evaluation

Monitoring of drug utilization and comprehensive clinical evaluation are fundamental tasks for promoting the return of drugs to their clinical value, important measures for consolidating and improving the essential medicine system, and specific requirements for strengthening the drug supply assurance system. Documents such as the Outline of the “Healthy China 2030” Plan, the 13th Five-Year Plan for Health and Wellness, and the 13th Five-Year Plan for Deepening the Reform of the Medical and Healthcare System have put forward clear requirements for drug utilization monitoring and comprehensive clinical evaluation. The new round of reform of Party and state institutions has established the conduct of drug utilization monitoring and comprehensive clinical evaluation as a statutory responsibility of health authorities. Health administrative departments at all levels must adhere to a people-centered approach to health, uphold the new development philosophy, and orient their work toward the clinical value of drugs. They should continuously enhance their sense of urgency and responsibility in addressing weaknesses and strengthening shortcomings in pharmaceutical administration, accelerate the establishment and improvement of standards, norms, and working mechanisms for drug utilization monitoring and comprehensive clinical evaluation, continually refine national drug policies, improve drug supply assurance capabilities, and promote scientific, rational, and safe medication use.

II. Comprehensive Implementation of Drug Utilization Monitoring

(1) Establish and improve a drug use monitoring system.

Leveraging the National Health Security Informatics Project and regional population health information platforms, a two-tier (national and provincial) drug utilization monitoring platform and a four-tier (national, provincial, municipal, and county) drug utilization monitoring network shall be established. These systems will enable functions such as data collection, statistical analysis, and information sharing on drug utilization, covering public healthcare institutions at all levels. The state shall organize the formulation of guidelines for drug utilization monitoring and related technical specifications to guide localities in carrying out work in an orderly manner. Provincial health administrative departments shall strengthen the development of regional population health information platforms to achieve interoperability with healthcare institutions’ information systems and centralized drug procurement platforms. Local health administrative departments at all levels shall enhance overall planning, organize healthcare institutions within their jurisdictions to accurately report drug utilization information as required, and promote intelligent monitoring of drug utilization based on healthcare institutions’ information systems, taking into account the actual conditions and characteristics of drug supply and use in their respective regions, so as to improve monitoring efficiency and reduce the workload at the grassroots level. Health administrative departments at all levels shall designate responsible entities and individuals accountable for drug utilization monitoring within their jurisdictions. Public healthcare institutions shall designate responsible departments and assign full-time or part-time personnel to report drug utilization information in a timely and accurate manner as required.

(II) Coordinate the implementation of drug utilization monitoring.

Adhere to the combination of comprehensive and targeted approaches, and promote implementation by category. First, conduct comprehensive monitoring. All public medical and health institutions shall actively cooperate as required, systematically collecting and reporting information on drug inventory varieties, manufacturers, usage volumes, procurement prices, supply and distribution, etc. Second, implement targeted monitoring. Select no fewer than 1,500 institutions from public medical and health institutions at all levels across China. Building upon comprehensive monitoring, conduct focused monitoring on specific data linking drug utilization with disease prevention and control, as well as follow-up tracking. Adhere to highlighting key priorities and implementing measures in stages. In 2019, pilot provinces of the Phase I National Health Security Informatics Project, pilot cities for national centralized drug procurement, and key monitored medical and health institutions in each province (autonomous region, and municipality) shall focus on drugs included in the National Essential Medicines List, those subject to special price reduction initiatives for anticancer drugs, and varieties under the national centralized drug procurement pilot program, carrying out drug utilization monitoring as required. In 2020, the monitoring scope will basically cover public medical institutions at secondary level and above, extending to primary-level medical and health institutions, gradually achieving monitoring of all equipped and used drugs. Private medical institutions and retail pharmacies are encouraged to participate voluntarily in drug utilization monitoring.

(3) Analyze and apply drug utilization monitoring data.

Health administrative departments at all levels and medical and health institutions shall strengthen the analysis and utilization of monitoring data. Based on the actual availability and use of medicines in medical institutions, they shall analyze the structure of medication categories, the use of essential and non-essential medicines, the use of generic and originator drugs, changes in procurement prices, and drug payment and reimbursement status. This will provide foundational information for comprehensive clinical evaluations and guide drug procurement by medical institutions as well as ensure continuity of medication practices between higher-level and lower-level medical institutions. On the basis of data analysis and in-depth mining, regular monitoring reports shall be prepared. Coordination and communication with departments such as industry and information technology, healthcare security, and drug supervision, as well as with centralized drug procurement agencies, shall be strengthened to promote the joint construction, sharing, and common use of data and information. These efforts aim to continuously and effectively safeguard drug supply and better facilitate the coordinated development of healthcare, medical insurance, and pharmaceutical sectors (“Three-Medical” linkage).

III. Solidly Advance the Comprehensive Clinical Evaluation of Drugs

(I) Strengthen the organizational management of comprehensive clinical evaluation of drugs. Enhance overall planning, effectively integrate resources, and fully leverage the roles of national and provincial medical institutions, research institutes, and industry associations to steadily and orderly advance the comprehensive clinical evaluation of drugs. The state shall organize the development of management guidelines, commission relevant technical institutions or industry associations to formulate technical specifications such as evaluation methods and standards, establish an expert committee for comprehensive clinical evaluation, and organize comprehensive evaluations focusing on selections from the National Essential Medicines List, the List of Encouraged Generic Drugs, and the List of Pediatric Drugs Encouraged for Research, Development, and Application. Provincial health administrative departments shall, in accordance with national deployments and relevant guideline requirements, while taking into account regional drug supply assurance and usage needs, mobilize superior resources to carry out comprehensive evaluations tailored to local conditions. Medical institutions, research institutes, and industry associations are encouraged to conduct comprehensive evaluations of the safety, efficacy, and economy of clinical drug use, leveraging their foundational accumulations, technical expertise, and clinical medication needs. When conducting comprehensive clinical evaluations of drugs, medical and health institutions at all levels shall make full use of drug utilization monitoring data and utilize the evaluation results as an important basis for formulating their drug procurement catalogs, promoting rational clinical drug use, providing pharmaceutical care services, and controlling unreasonable drug expenditure.

(II) Conduct comprehensive clinical evaluations of drugs in a scientific manner. Institutions implementing comprehensive clinical drug evaluations shall, based on actual needs, fully utilize health technology assessment methods and routine drug monitoring tools. They shall integrate knowledge systems from evidence-based medicine, epidemiology, clinical medicine, clinical pharmacy, evidence-based pharmacy, pharmacoeconomics, and health technology assessment. By comprehensively leveraging data such as drug market access approvals, results from large-scale multicenter clinical trials, adverse reaction monitoring, drug usage monitoring in healthcare institutions, “real-world” clinical practice data, and domestic and international literature, these institutions shall conduct qualitative and quantitative integrated analyses focusing on the safety, efficacy, economy, innovativeness, appropriateness, and accessibility of drugs. Provincial-level health administrative departments shall conduct an annual summary analysis of clinical comprehensive evaluations within their jurisdictions to timely grasp the progress and implementation status of such evaluations by medical institutions and relevant technical agencies. Throughout practical application, basic data shall be continuously accumulated and refined, research on grading the quality of evidence shall be strengthened, and a robust indicator system and multidimensional analysis models for drug technical evaluation and pharmaceutical policy assessment shall be established and improved, thereby promoting the scientific rigor and standardization of evaluation work.

(3) Establish a mechanism for linking the application of evaluation results. Health administrative departments at all levels shall scientifically apply the results of clinical comprehensive evaluations of drugs, strengthen communication and data sharing with medical insurance, drug regulation, and other relevant departments, and promote the improvement of pharmaceutical policies covering drug research and development, production, distribution, and use, thereby strengthening the drug supply guarantee system. Emphasize the clinical value of drugs and facilitate the use of relevant evidence in the selection and dynamic adjustment of the National Essential Medicines List, drugs encouraged for generic replication, and pediatric drugs encouraged for research, development, and registration; guide drug procurement by medical institutions and ensure continuity of medication between medical institutions at different hierarchical levels, continuously optimize the medication structure within medical institutions, and enhance the safety and rationality of drug use; propose recommendations for drug pricing policies and supportive measures for the production of drugs included in the National Essential Medicines List; promote improved efficiency in the allocation of health resources and control unreasonable drug expenditure; and put forward rationalized suggestions for improving drug dosage forms, specifications, and packaging, thereby guiding enterprises to research, develop, and produce drugs that meet clinical needs.

IV. Organization and Implementation

(I) Strengthen organizational leadership. Conducting drug utilization monitoring and comprehensive clinical evaluation is an innovative and systematic endeavor. Health administrative departments at all levels should fully utilize and expand existing facility resources, refine policy measures, secure multi-party support, improve working mechanisms, strengthen personnel training, and promote orderly and standardized implementation. Establish and improve management systems, ensure effective risk prevention and control, and exercise prudence and caution in the public release of comprehensive clinical evaluation results. For comprehensive clinical evaluations organized and conducted by health administrative departments as needed, institutions and units undertaking or participating in the evaluation shall not publicly release or disclose relevant information without authorization and approval.

(II) Strengthen the implementation of responsibilities. Health administrative departments at all levels must clarify task allocations, and relevant institutions and units must make concerted efforts to ensure detailed, granular, and effective implementation. The Statistical Information Center of the National Health Commission shall provide technical support and dynamic maintenance for the basic database on drug use monitoring and the Drug Procurement and Use Identification (YPID) codes; formulate guidelines and related technical specifications for drug use monitoring; and undertake the construction, management, data analysis, and reporting of the National Drug Use Monitoring System. The National Health Commission’s Center for Medical Device and Pharmaceutical Management shall handle specific operational tasks related to the clinical comprehensive evaluation of drugs and propose recommendations for such evaluations. The Chinese Academy of Medical Sciences’ Institute of Medical Information & Library (acting as the Health Development Research Center under the NHC framework) shall take the lead in organizing the formulation of management guidelines and related technical specifications for the clinical comprehensive evaluation of drugs, and provide technical guidance and consultation; in developing these guidelines and technical specifications, full advantage shall be taken of the expertise of relevant medical institutions, research institutes, and professional academic societies and industry associations. National-level institutions such as the National Center for Cardiovascular Diseases and the National Cancer Center shall play a leading and demonstrative role by undertaking the development of specialized guidelines for the clinical comprehensive evaluation of drugs, proactively collecting clinical evidence, conducting relevant evaluations, and promoting the application of evaluation results.

(3) Ensuring Data Security. All localities shall, in accordance with the principle of “whoever manages is responsible, whoever authorizes is responsible, and whoever uses is responsible,” strengthen security and management across all stages of data collection, storage, mining, application, operation, and transmission during drug utilization monitoring and comprehensive clinical evaluation. Responsible entities shall establish and improve relevant security management systems, operational procedures, and technical standards; implement the “top leader” accountability system; strictly comply with national confidentiality regulations; and, in accordance with the requirements of the National Classified Protection System for Cybersecurity, build a trusted cybersecurity environment, enhance the security protection capabilities of critical information infrastructure and important information systems, and ensure data security. No entity or individual may obtain data through illegal means, nor may they unauthorizedly utilize or disclose data that is unapproved or beyond the scope of authorization.

National Health Commission

April 3, 2019