Guidance of the State Food and Drug Administration on the Construction of Drug Informative Traceability System

Nov. 12, 2018

China National Pharmaceutical Administration [2018] No. 35 Notice

For the implementation of the general office of the state council about accelerate the important product traceability system construction opinion "(countries do hair [2015] no. 95), to further improve the level of drug quality security, according to the food and drug supervision bureau about promoting producers or marketers of food and drug administration's opinions on improving the traceability system (food drug safety [2016] no. 122) and the ministry of commerce and other departments on the promotion of the construction of important product information tracing system guidance" (rank hair [2017] no. 53) and other relevant provisions, hereby is to establish a drug information tracing system put forward the following guidance.

1. Guiding ideology

According to the CPC central committee and the state council decision deployment, to ensure public security as the goal, based on the implement enterprise's main body responsibility, in order to achieve "a material yard, material code with the chase" as the direction, quickening construction of pharmaceutical information tracing system, strengthen the traceability information communication sharing, achieve all varieties, the whole process of traceability, promote the comprehensive control of drug quality and safety, enhance the level of drug quality security.

2. Work objectives

Drug listing permit holders, manufacturers, trading enterprises and users shall establish a drug traceability system by means of information technology, record and keep drug traceability data in a timely and accurate manner, form an interconnected drug traceability data chain, and realize that the source and destination of the whole process of drug production, circulation and use can be traced. Effectively prevent illegal drugs from entering legal channels; To ensure the occurrence of quality and safety risks of drugs can be recalled, the responsibility can be investigated. 

3. Basic principles

(1) The holder of the drug marketing license, the manufacturer, the distributor and the user shall bear their respective responsibilities. The drug marketing license holders, production enterprises, trading enterprises and users are the main body responsible for the quality and safety of drugs, and have retroactive obligations. The holder of the drug listing license and the manufacturer shall assume the main responsibility for the construction of the drug traceability system. The pharmaceutical trading enterprises and users shall cooperate with the holder of the drug listing license and the manufacturer to establish a complete drug traceability system and fulfill their respective traceability responsibilities.

(2) Departmental supervision and guidance. The pharmaceutical supervisory and administrative departments shall, in accordance with relevant laws and regulations and technical standards, supervise the establishment of drug traceability systems by drug listing permit holders, manufacturers, trading enterprises and users, and guide industry associations to play an active role in the construction of drug informative traceability system. 

(3) Classification and step-by-step implementation. Taking full account of the number, scale and management level of drug listing permit holders, production enterprises, trading enterprises and users, as well as the actual development of the industry, we should adhere to the principle of enterprise establishment and make gradual and orderly progress.

(4) Coordination among all parties. In accordance with the principle of territorial management, drug regulatory departments should, under the unified leadership of local governments, focus on coordination and close cooperation with market supervision, industry and information technology, commerce, health care, medical insurance and other departments to promote coordinated management of drug information traceability system and resource sharing. 

4. Scope of application

This guideline is applicable to the establishment of drug informative traceability system and the supervision and inspection of drug regulatory departments by drug listing license holders, production enterprises, trading enterprises and users.

5. Relevant requirements

(1) Identify key points and implement them step by step. Pharmaceutical supervisory and administrative departments of all provinces (districts and municipalities) may, in combination with the actual regulatory situation, formulate implementation plans and promote the construction of drug informative and traceability system step by step according to drug dosage forms and categories. Key products, such as vaccines, narcotic drugs, psychotropic drugs, pharmaceutical precursor chemicals and blood products, should take the lead in establishing  drug information traceability system. Establish drug information traceability system as soon as  possible for essential drugs, medical insurance reimbursement drugs and other products of  common concern to consumers; Other drugs are gradually incorporated into the drug information traceability system.

(2) Strengthen guidance and promote social governance. Local regulatory authorities should  strengthen policy guidance, urge enterprises to fulfill their main responsibilities, promote the  construction of an information traceability system for all links of drug production, circulation and use, and timely connect with the national credit system. It is necessary to innovate the working mechanism, mobilize the enthusiasm of all parties, exert the self-discipline role of the industry, and promote the construction of drug informative and traceability system into the industry development plan. It is necessary to strengthen the positive publicity of public opinion, give play to the role of the media, cultivate the public's awareness of drug informative and traceability, and strive to form a good working atmosphere for everyone to participate.


State Food and Drug Administration