State Food and Drug Administration: drug companies, drug dealers, pharmacies, all do drug traceability


Time:

2018-11-08

Medical network November 2nd drug traceability system, the State Food and Drug Administration officially issued a document, these drugs to take the lead in the establishment of drug information traceability system. On November 1, the State Food and Drug Administration issued the "Guiding Opinions of the State Food and Drug Administration on the Construction of Drug Information Traceability System", the State Food and Drug Administration [2018] No. 35 (hereinafter referred to as the "Opinions"). Key products such as drugs, psychotropic drugs, pharmaceutical precursor chemicals, and blood products should take the lead in establishing a drug information traceability system; essential drugs, medical insurance reimbursement drugs and other products of common concern to consumers as soon as possible to establish a drug information traceability system

Pharmaceutical Network November 2 drug traceability system, the State Food and Drug Administration officially issued a document, these drugs to take the lead in the establishment of drug information traceability system.

On November 1, the State Food and Drug Administration issued the "Guiding Opinions of the State Food and Drug Administration on the Construction of Drug Information Traceability System" State Food and Drug Administration [2018] No. 35 (hereinafter referred to as the "Opinions")

The "Opinions" clarified that key products such as vaccines, narcotic drugs, psychotropic drugs, pharmaceutical precursor chemicals, and blood products should take the lead in establishing a drug information traceability system; essential drugs, medical insurance reimbursement drugs and other products of common concern to consumers as soon as possible to establish a drug information traceability system; other drugs gradually into the drug information traceability system.

▍ The main body responsible for the construction of the traceability system is the holder and the production enterprise

drug marketing license holder, the production enterprise, the business enterprise, and the user unit. Drug marketing license holders, production enterprises, business enterprises and users are the main body responsible for drug quality and safety, and have the obligation of traceability. Drug marketing license holders and production enterprises bear the main responsibility for the construction of drug traceability system, and drug trading enterprises and users shall cooperate with drug marketing license holders and production enterprises to establish a complete drug traceability system and fulfill their respective traceability responsibilities.

All parties are coordinated. According to the principle of territorial management, the drug supervision and management department should, under the unified leadership of the local government, pay attention to the overall coordination and close cooperation with the market supervision, industry and information technology, commerce, health, medical insurance and other departments to promote the coordinated management and resource sharing of the drug information traceability system.

▍ Pharmaceutical factories, drug approvers and drug dealers have their own responsibilities

Drug marketing license holders and manufacturers can build their own drug information traceability system or use the services of third-party technical institutions. Drug trading enterprises and users shall cooperate with drug marketing license holders and production enterprises to build traceability systems, and upload corresponding traceability information to the traceability system.

Holders of drug marketing licenses and manufacturers shall fulfill the responsibility of drug information traceability management, and in accordance with the requirements of unified drug traceability codes, assign unique traceability marks to the sales and packaging units of products at all levels to realize information traceability. When selling drugs, drug marketing license holders and manufacturers should provide relevant traceability information to downstream enterprises or medical institutions so that downstream enterprises or medical institutions can verify feedback. Drug marketing license holders and manufacturers should be able to obtain timely and accurate information on the whole process of circulation and use of drugs produced.

When purchasing drugs, a drug wholesale enterprise shall obtain relevant traceability information from upstream enterprises, check it during drug acceptance, and feedback the check information to upstream enterprises; when selling drugs, it shall provide relevant traceability information to downstream enterprises or medical institutions.

When purchasing drugs, drug retail and user units shall obtain relevant traceability information from upstream enterprises, check them during drug acceptance, and feedback the check information to upstream enterprises; When selling drugs, the sales record details shall be kept and the corresponding status identification of the sold drugs shall be adjusted in time.

Encourage information technology companies to act as third-party technical institutions to provide drug traceability information technology services to drug marketing license holders, manufacturers, operating companies, and users.

▍ Data Who Generates, Who Owns

Expand Drug Traceability Data Value. Drug supervision and management departments at all levels build a big data supervision system based on the drug information traceability system, innovate drug safety supervision methods, explore the implementation of the whole process of drug information and intelligent supervision, and improve the risk early warning mechanism.

Give full play to the role of drug traceability data in the recall of problem products and emergency disposal work, and further explore the application value of drug traceability data in supervision and inspection, product sampling and daily supervision. Drug traceability data "who produces, who owns", without the authorization of all parties, other parties shall not disclose. Relevant parties are encouraged to use drug traceability data to serve the society in accordance with legal compliance.

▍ Data preservation not less than five years

to establish a data security mechanism. All parties involved in drug traceability shall ensure the authenticity, accuracy, integrity, non-falsification and traceability of drug traceability data in terms of system and technology. Drug traceability data records and vouchers shall be kept for a period of not less than five years. Full-time departments and personnel shall be responsible for the management of drug traceability data to ensure data security and prevent data leakage.

The drug supervision and administration department shall guide and supervise the construction of the traceability system. Drug supervision and management departments should fulfill the responsibility of guidance and supervision, and build a retrospective supervision system according to the needs of supervision. The provincial drug supervision and administration department shall formulate specific measures and clarify the responsibilities at all levels in accordance with relevant laws, regulations and standards, combined with the actual situation of the administrative region.

local drug supervision and administration departments should strengthen the supervision and inspection of the establishment of information traceability system for drug marketing license holders, production enterprises, business enterprises and users, and 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 in accordance with the requirements and the traceability system cannot operate effectively, it shall be dealt with seriously in accordance with relevant laws and regulations.

▍ vaccines, narcotic, psychotropic and other drugs to start

clear focus, step by step. The drug supervision and administration departments of all provinces (autonomous regions and municipalities) may formulate implementation plans in the light of the actual supervision, and promote the construction of the drug information traceability system step by step according to the dosage forms and categories of drugs. Vaccines, narcotic drugs, psychotropic drugs, pharmaceutical precursor chemicals, blood products and other key products should take the lead in establishing a drug information traceability system; essential drugs, medical insurance reimbursement drugs and other products that consumers are generally concerned about should establish a drug information traceability system as soon as possible; Other drugs are gradually incorporated into the drug information traceability system.