The Drug Administration of all provinces, autonomous regions, and municipalities directly under the Central Government, and the Drug Administration of Xinjiang Production and Construction Corps:

In order to further implement the decision and deployment of the Party Central Committee and the State Council on the state-organized centralized procurement and use of drugs, strengthen the quality supervision of the centralized procurement and use of selected drugs, and effectively ensure the safety of the people's drug use. The State Food and Drug Administration has decided to conduct special inspections on selected drugs for the centralized procurement and use of drugs organized by the state. The relevant matters are hereby notified as follows:

1. Work goals

In order to deepen the reform of the medical and health system, and promote the linkage of the “three medical treatments” of medical care, medical insurance, and medicine, in accordance with the principles of risk management, full-process management and control, and social co-governance, through enterprise self-inspection and centralized inspection, the four strictest drug supervision and management "Requirements and territorial regulatory responsibilities, fully implement the quality principal responsibility of the selected drug marketing license holders, fully implement the two full coverage of the selected drug supervision and inspection and random inspection, further enhance the quality assurance ability of the selected drug marketing license holders, and further protect the selected drug For drug quality and safety, the traceability requirements of "one product, one code" for selected drugs have been further implemented.

2. Inspection content

(1) Key products: "Notice of the General Office of the State Council on Printing and Distributing the Pilot Program for the Centralized Procurement and Use of Drugs Organized by the State" (Guobanfa [2019] No. 2), "Regarding the Implementation of the Expansion of the Regional Scope of the Pilot Program for Centralized Procurement and Use of Drugs by the State Opinions” (Yibaofa (2019) No. 56), “Notice on Carrying out the Second Batch of Centralized Procurement and Use of National-Organized Drugs” (Yibaofa (2020) No. 2), and subsequent inclusion in the national-organized centralized procurement and use of drugs Selected drugs.

(2) Key content: the implementation of the drug production quality management specifications and the authenticity of the data in the production of the selected drugs; the implementation of the quality control of the raw materials and the strict control of the source quality risk; the production in accordance with the national drug standards and the production process approved by the drug regulatory authority Circumstances; the entrusting parties implement the responsibility of the entrusted production quality management; the implementation of pharmacovigilance and adverse drug reaction monitoring, the handling and control of quality and safety risk drugs such as unqualified sampling inspections; the manufacturer reports the production capacity of the selected drugs to the joint procurement office; the selected drugs The status of the implementation of the drug information traceability system by the marketing license holder; the quality management status of the selected drug delivery units and relevant medical institutions and retail enterprises.

3. Work arrangement

(1) Enterprise self-examination stage (from the date of publication to June 2020). The provincial-level drug regulatory agencies, in accordance with the actual regulatory conditions in their jurisdictions, formulate special inspection work plans in accordance with the requirements of this notice to ensure the coverage and pertinence of special inspections. Organize drug marketing license holders or manufacturers to conduct self-inspection on the production process of selected drugs, conduct risk assessment, cause analysis, and formulate corrective measures for corporate self-inspection, drug regulatory department investigations, and social concerns that may affect drug quality risks. Form a self-examination rectification report. Submit the self-inspection rectification report (with official seal) to the local provincial drug regulatory authority before June 30, 2020.

(2) Centralized inspection stage (July to September). The provincial drug regulatory agencies organize centralized inspections of selected drugs within their jurisdiction. It is necessary to strengthen the problem orientation, unblock the channels for complaints and reports, implement "one company, one file" management for selected drug manufacturers, and carry out full coverage inspections. It is necessary to establish a supervisory ledger, supervise the enterprises to rectify the hidden dangers of related problems within a time limit, and write off the account numbers one by one. It is necessary to implement full coverage random inspections on selected drugs in the production process. It is necessary to supervise the selected drug marketing license holders to accelerate the construction of a drug information traceability system. Local drug regulatory authorities shall, in accordance with their duties, supervise and urge the delivery units of the selected drugs, relevant medical institutions, and retail companies to continue to comply with regulations, and ensure the quality and safety of the selected drugs in the circulation and use links. It is necessary to strengthen work research and organize timely research and judgment of problems found in supervision work and relevant work suggestions.

(3) Final report stage (October). All provincial-level drug regulatory agencies should comprehensively summarize the good practices and experiences of special inspections. The work summary should be reported to the Drug Supervision Department of the State Drug Administration before October 30, 2020. Timely reports on the investigation and handling of major cases, innovation in supervision work, and investigations in the industry.

4. Job requirements

(1) Raise awareness and implement conscientiously. The state’s organization of centralized drug procurement and use is an important decision and deployment of the Party Central Committee and the State Council, as well as an important measure to deepen the reform of the medical and health system. Drug regulatory agencies at all levels must further improve their political positions and earnestly understand their ideological understanding from a political and overall perspective. Unified to the decision-making and deployment of the Party Central Committee. We must adhere to the people-centered approach, fully implement the "four strictest" requirements for drug supervision, implement the Party Central Committee’s requirements for the overall planning of the prevention and control of the new crown pneumonia epidemic and the deployment of economic and social development, and formulate work plans and arrangements based on actual conditions. Various regulatory measures ensure that special inspections are completed on time, implement full-coverage supervision and inspection and product random inspections on selected drugs, promote enterprises to implement their main responsibilities, and effectively ensure drug quality and safety.

(2) Strengthen supervision and information sharing. Drug regulatory authorities at all levels must supervise and urge companies to strictly abide by the drug production quality management specifications and drug business quality management specifications, and ensure that the drug production and business processes continue to meet legal requirements. For product quality and safety risks discovered during inspections, effective measures shall be taken in time to prevent further expansion of the hazards; for abnormal risk signals and clustering signals discovered in adverse reaction monitoring, timely organization and disposal shall be conducted. It is necessary to strengthen information communication between provincial drug regulatory agencies and various functional departments, unblock the information notification mechanism, form a regulatory force, supervise drug manufacturers to implement product supply guarantee responsibilities, and truthfully report production capacity to the joint procurement office in a timely manner.

(3) Strengthen publicity and create atmosphere. Drug regulatory authorities at all levels should use the newly revised "Drug Administration Law" and "Drug Production Supervision and Administration Measures" and other supporting regulations and implementation opportunities to closely integrate the publicity and implementation of laws and regulations with the supervision of selected drugs, strengthen publicity and training, and create a good Atmosphere. It is necessary to conduct in-depth investigations and studies to discover and determine the factors that affect the quality and safety of drugs in time. It is necessary to properly respond to hot issues of public opinion and respond to social concerns in a timely manner.

(4) Investigate and deal with according to law and report in time. All provincial-level drug regulatory agencies must resolutely investigate and punish all types of illegal acts strictly in accordance with the law, draw inferences from one another, and set examples. Those who are suspected of committing a crime shall be promptly transferred to the public security organ. The investigation and handling of the quality problems of the selected drugs shall be reported to the people's government at the same level in a timely manner, and at the same time to the State Drug Administration. The State Food and Drug Administration will organize supervision and inspection in due course in light of the actual situation, and notify those who find that the supervision work is not in place.

The problems and suggestions in the special inspection work are reported to the State Drug Administration in a timely manner.

National Food and Drug Administration

March 10, 2020