[quick news] the State Food and Drug Administration issued a new policy on drug information traceability

In order to implement the opinions of the general office of the State Council on accelerating the construction of traceability system for important products (GBF [2015] No 95) and further improve the level of drug quality and safety assurance, according to the opinions of the food and Drug Administration on promoting the improvement of traceability system for food and drug producers and operators (SFJC [2016] No 122) and the opinions of the Ministry of Commerce and other departments on promoting Guidance on the construction of information traceability system for important products (SRF [2017] No 53) and other relevant regulations are hereby proposed as follows for the establishment of drug information traceability system 1、 Guiding ideology According to the decision-making and deployment of the Party Central Committee and the State Council, with the goal of ensuring the public drug safety, based on the implementation of the main responsibility of the enterprise, and with the direction of "one thing, one code, and the same code", accelerate the construction of drug information traceability system, strengthen the exchange and sharing of traceability information, realize the traceability of the whole variety and the whole process, promote the comprehensive management of drug quality and safety, and improve the drug quality Security level 2、 Work objectives Drug listing license holders, production enterprises, trading enterprises and users establish drug traceability system by means of information technology, timely and accurately record and save drug traceability data, form an interconnected drug traceability data chain, and realize the whole process of drug production, circulation and use of traceable sources and directions; effectively prevent illegal drugs from entering legal channels; ensure the occurrence of quality Drugs with safety risks can be recalled and responsibilities can be investigated The whole process of drug traceability system covering the whole process has been jointly established in the links of drug production, circulation and use The quality management level of drug listing license holders, production enterprises, trading enterprises and users has been significantly improved The level and efficiency of supervision informatization of drug supervision and administration departments have been gradually improved The industry association has actively played a bridge and link in the construction of drug informatization traceability system Lead the demonstration role, realize the public independent inspection of drug information traceability data, and improve the awareness of the whole society on drug information traceability 3、 Basic principles (1) the holders of drug listing licenses, production enterprises, trading enterprises and users shall bear their respective responsibilities Drug listing license holders, production enterprises, trading enterprises and users are the main bodies responsible for drug quality and safety, and have the retroactive obligation The drug listing license holder and the manufacturer shall bear the main responsibility for the construction of the drug traceability system The drug trading enterprise and the user shall cooperate with the drug listing license holder and the manufacturer to establish a complete drug traceability system and fulfill their respective traceability responsibilities （2） Department supervision and guidance According to the relevant regulations and technical standards, the drug regulatory department shall supervise the drug listing license holders, production enterprises, trading enterprises and users to establish a drug traceability system, and guide the industry associations to play an active role in the construction of drug information traceability system （3） Classified and step-by-step implementation Fully consider the number, scale and management level of drug listing license holders, production enterprises, trading enterprises and users, as well as the actual development of the industry, adhere to the principle of enterprise establishment, and gradually and orderly promote （4） All parties shall coordinate as a whole According to the principle of territorial management, under the unified leadership of the local government, the drug supervision and administration department should pay attention to the overall coordination and close cooperation with the market supervision, industry and information technology, commerce, health care, medical insurance and other departments, so as to promote the collaborative management and resource sharing of the drug information traceability system 4、 Scope of application these guidelines are applicable to the establishment of drug information traceability system by drug listing license holders, production enterprises, trading enterprises and users, and the supervision and inspection of drug supervision and administration departments 5、 Work task (1) prepare unified information traceability standards In combination with the actual needs of the construction of drug information traceability system, the State Drug Administration plans to establish the drug information traceability standard system, define the basic requirements, issue the construction guide of the traceability system, unify the requirements of drug traceability coding, data and exchange standards （2） Build information drug traceability system Drug information traceability system is an organic whole of traceability related parties of drug quality and safety, such as drug listing license holders, production enterprises, trading enterprises, users, drug supervision and administration departments, consumers, etc by means of information technology, the information of drug production, circulation, use and other links is tracked and traced Drug listing license holders, production enterprises, trading enterprises and users shall abide by relevant laws and regulations and technical standards, establish and improve the information traceability management system, and earnestly perform the main responsibilities Drug listing license holders, production enterprises, trading enterprises and users shall record relevant activities in accordance with the requirements of quality management specifications, the records shall be true, accurate, complete, tamper proof and traceable, and shall provide relevant data to the regulatory authorities in accordance with the regulatory requirements; the traceability information shall be stored, exchanged, interconnected and communicated through the drug traceability system, so as to serve the society Information inquiry will be provided by the public Drug marketing license holders and manufacturing enterprises may establish their own drug information traceability system, or adopt the services of third-party technical institutions Pharmaceutical trading enterprises and users shall cooperate with pharmaceutical marketing license holders and production enterprises to build a traceability system, and upload the corresponding traceability information to the traceability system Drug marketing license holders and production enterprises shall perform the responsibility of drug information traceability management, and assign unique traceability marks to the sales and packaging units at all levels of products in accordance with the requirements of unified drug traceability code, so as to realize information traceability When selling drugs, drug marketing license holders and manufacturers shall provide relevant traceability information to downstream enterprises or medical institutions for verification and feedback of downstream enterprises or medical institutions Drug marketing license holders and production enterprises should be able to obtain timely and accurate information about the whole process of circulation and use of the drugs they produce When purchasing drugs, drug wholesalers shall ask upstream enterprises for relevant traceability information, check it during drug acceptance, and feed back the verification information to upstream enterprises; when selling drugs, they shall provide downstream enterprises or medical institutions with relevant traceability information When purchasing drugs, drug retail and user units shall ask upstream enterprises for relevant traceability information, check it during drug acceptance, and feed back the check information to upstream enterprises; when selling drugs, they shall keep the details of sales records, and timely adjust the corresponding status identification of sold drugs Encourage information technology enterprises as the third-party technical institutions to provide drug traceability information technology services for drug listing license holders, production enterprises, trading enterprises and users （3） Promote the interconnection of traceability information The State Drug Administration has established a national drug information traceability collaborative service platform, and constantly improved the mechanism of drug traceability data exchange and sharing Encourage drug listing license holders, production enterprises, trading enterprises, users, industry associations, third-party service agencies, and administrative departments to realize the interconnection of drug information traceability parties through the drug traceability collaborative service platform Enterprises are encouraged to innovate query methods and provide drug traceability data query services to the public （4） Expand the value of drug traceability data Drug supervision and administration departments at all levels build big data supervision system based on drug information traceability system, innovate drug safety supervision means, explore the implementation of information-based and intelligent supervision of the whole process of drugs, and improve risk early warning mechanism Give full play to the role of drug traceability data in problem product recall and emergency response, and further tap the application value of drug traceability data in supervision and inspection, product sampling and daily supervision Drug traceability data "who produces and who owns" shall not be disclosed by other parties without authorization of the owner Encourage relevant parties to use drug traceability data to serve the society in accordance with legal and compliance methods （5） Establish data security mechanism All parties involved in drug traceability shall ensure the authenticity, accuracy, integrity, non tamperability and traceability of drug traceability data in terms of system and technology The retention period of drug traceability data records and vouchers shall not be less than five years The full-time departments and personnel shall be clear in charge of drug traceability data management to ensure data safety and prevent data leakage （6） The drug regulatory department shall guide and supervise the construction of traceability system The drug supervision and administration department shall fulfill the responsibilities of guidance and supervision, and build a retroactive supervision system according to the regulatory needs The provincial drug supervision and administration department shall, in accordance with the relevant laws, regulations and standards and in combination with the actual situation of the administrative region, formulate specific measures and clarify the responsibilities at all levels Local drug supervision and administration departments shall strengthen supervision and inspection on the establishment of information traceability system for drug listing license holders, production enterprises, trading enterprises and users, urge relevant units to strictly abide by the traceability management system, and establish and improve the traceability system If the traceability system is not established as required and cannot operate effectively, it shall be dealt with seriously according to relevant laws and regulations 6、 Relevant requirements (1) clear focus and step-by-step implementation The drug supervision and administration departments of all provinces (districts and cities) can formulate implementation plans based on the actual supervision, and promote the construction of drug information traceability system step by step according to drug dosage forms and categories Key products such as vaccines, anesthetics, psychotropic drugs, drug precursor chemicals and blood products should take the lead in establishing drug information traceability system; products of common concern to consumers such as basic drugs and medical insurance reimbursement drugs should establish drug information traceability system as soon as possible; other drugs should be gradually incorporated into drug information traceability system （2） Strengthen guidance and co governance Local regulatory authorities should strengthen policy guidance, urge enterprises to implement the main responsibility, promote the construction of information traceability system in all aspects of drug production, circulation and use, and timely connect with the national credit system We need to innovate the working mechanism, mobilize the enthusiasm of all parties, play the role of self-discipline in the industry, and promote the construction of drug information traceability system into the industry development plan We should strengthen the positive publicity of public opinion, give play to the role of the media, cultivate the public's awareness of drug information traceability, and strive to form a good working atmosphere for everyone to participate in SFDA October 31, 2018