The State Drug Administration issued a document to restart the electronic supervision of drugs

The State Drug Administration issued a message to restart electronic supervision of drugs!
August 24, the State Drug Administration issued the Guidance on the Construction of the Drug Information Tracing System (Draft for Comments) (hereinafter referred to as the Opinion).Pharmaceutical companies should build their own traceability systems and encourage the use of third-party platforms
According to the Opinion, drug market licensees, including those with drug approval numbers, bear the primary responsibility for the construction of drug traceability systems, and holders can build their own drug traceability systems or use the services of third-party technical institutions.
and the drug business unit are the responsible subjects for the quality and safety of the drug and have retrospective obligations. The holder bears the primary responsibility for the construction of the drug traceability system, and the drug operating unit cooperates with the holder in the construction of the traceability system and uploads the corresponding traceability information to the traceability system.
to encourage holders, pharmaceutical enterprises, users, trade associations, third-party service agencies, administrative departments through the drug traceability collaborative service platform, to achieve drug information tracing of the interconnection of all parties.
, some parts of China have begun to establish a traceability system for pharmaceutical products, such as Shandong, Fujian and other provinces have issued a document to promote the traceability system. Although there are many traceability systems in the society at present, there are no standards and norms on what content must be included and what signs should be used.Data "Who produces and who owns", the end of 2022 full coverage
Opinion requires that the ownership of drug traceability data is "who produces, who owns", in order to ensure that the drug traceability information is true, accurate, complete and traceable, the holder, pharmaceutical operators should choose a third party to back up, and ensure that the backup information is consistent with the original information.
, the use of third-party platforms is more practical for pharmaceutical companies than for self-built systems.
The purpose of the State Drug Administration is to form an interconnected drug traceability information data chain, to realize that the whole process of drug circulation can be traced and traceable, to effectively prevent fake and inferior drugs from entering legal channels, and to ensure that drugs with quality and safety problems can be recalled and held accountable.
opinion, the end of 2022 basically completed the drug information traceability system full coverage.Ali's health is making a comeback, or the first choice of pharmaceutical companies
drug traceability began on April 28, 2016, the former State Administration of Food and Drug Administration issued "on the further improvement of the food and drug traceability system (draft for comments).
also on January 25, 2016, a drug retail enterprise in Hunan Province, because of the drug electronic supervision code, the former State Administration of Food and Drug Administration to court, Ali Health is the only enterprise to promote the drug electronic supervision code. On February 20, the former State Administration of Food and Drug Administration issued a moratorium on the electronic regulatory code system, which has been in place for nearly a decade.
The drug traceability system implemented by the State Drug Administration is more comprehensive than the supervision of electronic regulatory codes, from raw material procurement to production and circulation, once the problem can be quickly and accurately traced back, which is also the international community's common regulatory system.
the current drug traceability system leader is Ali Health, according to Seberan. Together with regulators, industry organizations, pharmaceutical companies, technology service providers and the public, it has built a retrospective ecosystem that has become an important line of business for Ali.
years ago, Ali Health, which was knocked out of the electronic regulatory code, is likely to be the first of many pharmaceutical companies to cooperate.
attached: Guidance on the construction of the drug information traceability system
(draft for comments)
In order to implement the Opinions of the General Office of the State Council on Speeding Up the Construction of the Traceability System for Important Products (State Office Issued No. 95 of 2015), the Ministry of Commerce and other departments on promoting the construction of the information tracing system for important products (The Guidance on promoting the construction of the traceability system for important products) Shang Lifa (2017) No. 53) and the General Administration of Food and Drug Administration on promoting food and drug production operators to improve the traceability system of the opinion (Food and Drug Administration (2016) No. 122) and other documents, is now on the establishment of drug information traceability system, put forward the following guidance., guiding ideology
in accordance with the decision-making and deployment of the CPC Central Committee and the State Council, in order to ensure the safety of public drug use as the goal, accelerate the construction of drug information tracing system, promote the transformation and upgrading of the pharmaceutical industry. Based on the implementation of the main responsibility of enterprises, in order to achieve "one thing, one yard, one code and chase" as the direction, to build the whole process of drug information traceability system, improve the drug information traceability standards and norms, strengthen the sharing of traceability information, promote comprehensive management of drug quality and safety, improve the level of drug quality and safety. II. Work objectives
Drug market license holders (including pharmaceutical production enterprises holding drug approval numbers, referred to as holders), operating and using units through information technology to establish drug traceability system, timely and accurate recording, preservation of drug traceability information, the formation of an interconnected drug traceability information data chain, to achieve the whole process of drug circulation sources can be traced, to recover;
Drug production, circulation and use and other links to jointly build a drug traceability system covering the whole process, the holder, drug management enterprise quality management level significantly improved, drug supervision and management departments of the level of regulatory information and regulatory efficiency gradually improved, industry associations actively play the role of the bridge between the construction of drug information traceability system and lead the demonstration role, the public awareness of drug information traceability has steadily increased, to achieve drug information traceability information can be independently verified. , the basic principles
the establishment of drug information traceability system, should follow the following basic principles:
(1) holders, drug business and use units are responsible for their own. The holder and the unit of drug operation and use are the responsible subjects for the quality and safety of drugs and have retrospective obligations. The holder bears the primary responsibility for the construction of the drug traceability system, and the operating enterprises and users actively cooperate with the holders to build a complete drug traceability system and fulfill their respective retrospective responsibilities.
(ii) department supervision and guidance. The drug supervision and administration department shall, in accordance with relevant regulations and technical standards, supervise the holders and drug business units to establish a drug traceability system and guide trade associations to play an active role in the construction of the drug information traceability system.
(iii) classification step-by-step implementation. Taking full account of the number of holders, pharmaceutical business units and management level, as well as the actual development of the industry, adhere to the principle of enterprise establishment, and gradually and orderly progress.
(iv) The parties coordinate and coordinate. In accordance with the principle of territory management, under the unified leadership of local governments, drug supervision and administration departments should pay attention to coordination and close cooperation with the departments of industry and information technology, commerce, health, health care and other departments, and promote the coordinated management and sharing of resources in the drug information tracing system. , scope of application
this guidance applies to holders, drug business and use units to establish drug traceability system and drug supervision and management departments of supervision and inspection. This guidance does not apply to Chinese herbal medicine, Chinese medicine tablets, raw materials and special packaging preparations production and operation enterprises. , the task of the
(i) to prepare a unified information traceability standards. Combined with the actual needs of the construction of the drug information traceability system, the State Drug Administration plans to establish the drug information traceability standard system, clarify the basic requirements, issue the traceability system construction guidance (Annex 1), unified drug traceability coding requirements (Annex 2), data and exchange standards.
(2) Enterprises to build information-based drug traceability system. Holders and pharmaceutical enterprises shall abide by relevant regulations and technical standards, establish and improve the information tracing management system, and earnestly fulfill the main responsibilities. The holder or pharmaceutical business enterprise shall record the relevant activities in accordance with the requirements of the quality management standards, 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; Holders can build their own drug traceability systems or use the services of third-party technical institutions. Drug operating units work with the holders to build a traceability system, and the corresponding traceability information uploaded to the traceability system.
holders shall fulfill the responsibility of drug information traceability management and, in accordance with the coding requirements put forward by the drug supervision and administration department, assign a unique traceability mark to the sales and packaging units at all levels of the product in order to realize the information traceability. When selling medicines, the holder shall provide traceability information to the downstream enterprise or medical institution so that the downstream enterprise or medical institution can verify the feedback. Holders should be able to obtain timely and accurate information on the circulation and use of the drugs produced.
pharmaceutical wholesale enterprises shall, when purchasing drugs, obtain relevant retrospective information from upstream enterprises and check them at the time of drug acceptance, and provide relevant retrospective information to downstream enterprises or medical institutions when selling drugs.
When purchasing drugs, the retail and user units of pharmaceuticals shall obtain relevant retrospective information from upstream enterprises and check them at the time of drug acceptance, and shall keep details of sales records and adjust the corresponding status identification of the drugs sold in a timely manner.
information technology enterprises, as third-party technical institutions, are encouraged to provide drug traceability information services to holders, pharmaceutical operators and users.
(iii) to promote retrospective information connectivity. The State Drug Administration has established a national drug traceability coordination service platform and continuously improved the mechanism for the exchange and sharing of drug traceability information. Holders, pharmaceutical enterprises, users, trade associations, third-party service agencies and administrative departments are encouraged to realize the interconnection of drug information tracing through the drug traceability and coordination service platform. Enterprises are encouraged to innovate the way of inquiry and provide drug traceability information inquiry services to the public.
(iv) to expand the value of drug traceability information. Drug supervision and administration departments at all levels build big data supervision system based on drug information traceability system, innovate drug quality supervision means, explore the implementation of drug information technology, intelligent supervision, improve the risk early warning mechanism. Give full play to the role of drug traceability information in the work of problem product recall and emergency disposal mechanism, and further excavate the application value of drug traceability information in supervision and inspection, product sampling and daily supervision.
ownership of drug traceability data is "who produces and who owns it", and the operator of the drug information traceability system may not disclose traceable information to third parties without the authorization of all parties. Third parties are encouraged to use drug traceability data to serve the community in a compliant and reasonable manner. Industry associations and holders and pharmaceutical operators are encouraged to explore the drug traceability data market trading mechanism and establish a long-term mechanism for drug traceability.
(v) to establish a data security mechanism. Drug traceability parties should properly keep the drug traceability information, clear the duties of custodians, to prevent the occurrence of information damage, loss and other issues. Trace system operators should ensure the privacy and security of system user data. The record and voucher of drug traceability shall be kept for not less than five years after the expiration of the drug. The information collected by the drug traceability system should be technically and institutionally guaranteed to be non-tamperable. To ensure true, accurate, complete and traceable drug traceability information, it is advisable for holders and pharmaceutical operators to select a third party to back up and ensure that the backup information is consistent with the original information.
(6) The drug supervision and administration department shall guide and supervise the construction of the traceability system. The drug regulatory authority shall fulfill its guidance and regulatory responsibilities and collect the necessary data in accordance with regulatory requirements. The provincial drug regulatory departments shall, in accordance with the relevant laws, regulations and standards and these Provisions, formulate specific measures and clarify responsibilities at all levels in the light of the actual situation in the administrative region.
local drug supervision and administration departments should strengthen supervision and inspection of the establishment of an information-based traceability system for holders and drug business units, and urge relevant units to strictly abide by the traceability management system and establish and improve the traceability system. For 10 not in accordance with the requirements of the establishment of traceability system, traceability system can not operate effectively, in accordance with the relevant laws and regulations and other provisions to seriously deal with. , the relevant requirements
(1) clear focus, step-by-step implementation. The provinces (districts and cities) may, in conjunction with the actual supervision and implementation plan, step-by-step promote the construction of the drug information traceability system according to the dosage form and category of drugs. Key products and key enterprises should take the lead in the retrospective system, and give priority to the basic drugs, medical insurance reimbursement drugs and other products of general concern to consumers into the traceability system. By the end of 2022, the drug information tracing system will be basically completed.
(ii) strengthen guidance and social co-governance. We should give full play to the role of industry self-discipline and exemplary leadership, explore the industry's own development planning and credit management system for the construction of drug information tracing system, carry out various forms of demonstration and creation activities around the key difficulties and weak links in the construction of traceability system, and innovate the working mechanism and mobilize the enthusiasm of all parties. We should strengthen the policy guidance of local regulatory departments, urge enterprises to carry out the main responsibility, actively promote the construction of information tracing system in the pharmaceutical production and operation links, and timely docking the national credit system. We should strengthen the positive publicity of public opinion, play the role of the media, cultivate the public's awareness of drug traceability, and strive to form a good working atmosphere in which everyone participates.
(Note: Drug information traceability system is the drug market license holders, operating enterprises, user units, drug supervision and management departments, consumers and other related traceability related to drug quality and safety, through information technology, drug production, circulation, use and other aspects of the information tracking, traceability of the organic whole. Drug traceability collaborative service platform is an information service platform to realize the interconnection of drug traceability system, which can provide access address resolution of different traceability systems, record and management of drug traceability code rules, as well as drugs, enterprise basic data distribution and other services. (Seber Blue)