Drug Administration: National selection of selected varieties by the end of December to complete the whole process of retrospective.

On August 31st, the State Drug Administration officially issued a "announcement on the construction of a traceability system for key varieties" (draft for comments) (hereinafter referred to as "draft for comments").
Draft for Comments pointed out that drug market license holders should implement the main responsibility of quality management of the whole process, establish an information-based traceability system, and collect the whole process of traceability information.
december 31, 2020, the basic realization of the national centralized procurement of drugs selected varieties, narcotic drugs, psychotic drugs, blood products and other key varieties can be traced.
8 construction standards have been issued at present, the standards required for the construction of drug information traceability system have all been issued and implemented, including "Drug information traceability system construction guidance", "drug traceability code coding requirements" "drug traceability system basic technical requirements" "drug production enterprises traceability basic data set" "drug operating enterprises traceability basic data set" "drug traceability data public inquiry basic data set" "drug traceability data exchange basic technical requirements" a total of 8 construction standards.
The Draft for Comments points out that drug market license holders and pharmaceutical enterprises shall establish and implement drug traceability systems in accordance with standards and normative requirements such as 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.
, drugs of the same packaging specification are only allowed to be traced in the same traceability system.
At the time of production, the storage information should be stored in the traceability system, and when selling drugs, the relevant traceability information should be provided to the downstream related enterprises or related institutions through the traceability system, so that the downstream enterprises can verify the feedback.
drug market licensing holders to achieve timely and accurate access to the entire process of the drug produced information.
licensing holders of imported drugs may entrust the imported drug agency enterprises to fulfill their responsibility for the construction of the traceability system.
interview on the different traceability systems, the reporter of the Pharmaceutical Economics Daily learned that the State Drug Administration has built a collaborative service platform for drug traceability (hereinafter referred to as a collaborative platform) and continuously improved the mechanism for data exchange and sharing of drug traceability.
collaborative platform provides drug traceability code coding rules for filing and drug listing 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 Draft also shows that the State Drug Administration has built a national drug information tracing supervision system, and provincial drug regulatory departments have built the province's drug information traceability supervision system in accordance with regulatory needs, conducted data collection, monitored drug flows, and given full play to the role of traceability information in daily supervision, risk prevention and control, product recall, emergency disposal and other regulatory work. The relevant person in charge of
stressed: "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 agencies 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;
The State Drug Administration will strengthen overall coordination and technical guidance, and timely organization of supervision and inspection.
"The announcement of the State Drug Administration on the construction of a traceability system for key varieties informationization (draft for comments) for the implementation of 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 issued (2015) 95 No.), to effectively protect the safety of the people's drug use, is now to do a good job in the key varieties of information tracing related matters notice as follows: First, the overall requirements of the implementation of the Drug Administration Law and the State Council on drug traceability deployment requirements, and actively promote the construction of drug information tracing system, improve the level and efficiency of drug supervision work, and effectively ensure the quality and safety of drugs.
drug market license holders should implement the main responsibility of quality management of the whole process, establish an information-based traceability system, and collect the whole process traceability information.
december 31, 2020, the basic realization of the national centralized procurement of drugs selected varieties, narcotic drugs, psychotic drugs, blood products and other key varieties can be traced.
, task arrangements (1) the State Drug Administration is responsible for the development of unified drug traceability standards and norms.
At present, all the standards required 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 the Traceability of Drug Manufacturers, the Basic Data Set for the Traceability of Drug Operating Enterprises, the Basic Data Set for the Traceability of Drug Use Units, the Basic Data Set for Public Inquiry of Drug Trace Data, and the Basic Technical Requirements for Drug Traceability 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 listing 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 tracing 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 listing license holders and pharmaceutical business enterprises shall establish and implement drug traceability systems in accordance with standards and normative requirements such as the Regulations on the Retrospective Construction of Drug Informationization, provide retrospective information and ensure drug traceability.
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.
drugs of the same packaging specification are allowed to be traced only in the same traceability system.
At the time of production, the storage information should be stored in the traceability system, and when selling drugs, the relevant traceability information should be provided to the downstream related enterprises or related institutions through the traceability system, so that the downstream enterprises can verify the feedback.
drug market licensing holders to achieve timely and accurate access to the entire process of the drug produced information.
licensing holders of imported drugs may entrust the imported drug agency enterprises to fulfill their responsibility for the construction of the traceability system.
, the work requires the establishment and implementation of the construction of drug traceability system, is the clear requirements of the Drug Administration Law, is an important decision-making deployment of the State Council, is 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 agencies 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;
The State Drug Administration will strengthen overall coordination and technical guidance, and timely organization of supervision and inspection.
.