The announcement of the State Drug Administration on the construction of a traceability system for key varieties of information technology

In order to implement the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law) and the Opinions of the General Office of the State Council on Speeding Up the Construction of the Traceability System for Important Products (State Administration No. 95), and to effectively protect the safety of drug use by the people, the following announcements are made on matters related to the tracing of key varieties of information: First, the overall requirements for the implementation of the Drug Administration Law and the State Council's requirements for the retrospective deployment of drugs, and actively promote the construction of the drug traceability system and improve the level of drug safety.
Drug market license holders shall implement the main responsibility of drug quality management throughout the process, establish an information-based traceability system, collect traceability information on the whole process, and, by December 31, 2020, basically realize the traceability of key varieties such as selected varieties, narcotic drugs, psychotic drugs and blood products in the centralized procurement of national drugs.
, task arrangements (1) the State Drug Administration is responsible for the development of unified drug traceability standards and norms.
At present, all eight standards for the construction of the drug information traceability system have been issued and implemented, including the Guidance for the Construction of the Drug Information Trace System, the Requirements for drug traceability code coding, the Basic Technical Requirements for drug traceability systems, the Basic Data Set for drug listing license holders and production enterprises, the Basic Data Set for the Traceability of Drug Operating Enterprises, the Basic Data Set for drug Use Unit Traceability, the Basic Data Set for Drug Trace Consumer Inquiry, and the Basic Technical Requirements for Drug Trace Data Exchange.
the State Drug Administration to build a drug traceability collaborative service platform (hereinafter referred to as a collaborative platform), and constantly improve the drug traceability data exchange, sharing mechanism.
collaborative platform provides drug traceability code coding rules for filing and drug market licensing license holders drug information traceability system (hereinafter referred to as traceability system) address resolution services, to assist in the realization of different traceability systems for mutual enjoyment, to achieve the whole process of drug traceability.
The State Drug Administration builds a national drug information retrospective supervision system, and provincial drug regulatory departments, in accordance with regulatory needs, build the province's drug information traceability supervision system, conduct data collection, monitor drug flows, and give full play to the role of traceability information in daily supervision, risk prevention and control, product recall, emergency disposal and other regulatory work.
(2) Drug market license holders and pharmaceutical business enterprises shall establish and implement drug traceability systems in accordance with the standards and normative requirements of the Regulations on the Retrospective Construction of Drug Informationization, provide retrospective information and ensure the traceability of drugs.
Drug listing license holders bear the primary responsibility for the construction of the traceability system, can build their own traceability system, can also entrust the construction of third-party technical institutions, in accordance with the unified drug traceability coding requirements, the drug sales and packaging units at all levels to assign a unique traceability mark.
the same drug traceability code, allowing only traceability in the same traceability system.
if an enterprise wants to change a traceability code or traceability system, changes can be made on the collaborative platform as required.
When the production is in storage, the storage information should be stored in the traceability system, and when selling drugs, the relevant trace information should be provided to the downstream related enterprises or medical institutions through the traceability system, so that the downstream enterprises or medical institutions can verify the feedback.
timely and accurate access to information on the entire process of the drugs produced by the licensed holders of the drug market.
licensing holders of imported drugs may entrust the imported drug agency to fulfill its responsibility for the construction of the traceability system.
When purchasing drugs, pharmaceutical enterprises shall obtain relevant traceability information from upstream enterprises through the traceability system, check them at the time of drug acceptance, and return the checking information to upstream enterprises through the traceability system, and provide traceability information to downstream enterprises or relevant institutions through traceability systems when selling drugs.
. The establishment and implementation of the drug traceability system is a clear requirement of the Drug Administration Law, an important decision-making and deployment of the State Council, and an important means to ensure the safety of drug use by the people.
all relevant parties must attach great importance to, urgently deploy and speed up implementation.
Drug supervision and administration departments at all levels shall, in accordance with their duties and responsibilities, strengthen the administrative guidance and supervision and inspection of drug listing license holders, import drug agency enterprises and pharmaceutical business enterprises in their jurisdictions, and urge them to implement retrospective responsibilities in accordance with the Drug Administration Law and the standards for the retrospective construction of drug information;
Drug Administration will strengthen overall coordination and technical guidance, and timely organization of supervision and inspection.