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State Drug Administration: Promote the construction of a pharmaceutical information traceability system such as vaccine such as vaccination
Release time: 2018-12-06 & nbsp & nbsp & nbsp Source: Anonymous

Yesterday, The State Drug Administration issued the "Guiding Opinions on the Construction of the Drug Information Entertainment Traceback System" (hereinafter referred to as "Opinions")。Opinions are proposed according to the dosage type、Category step by step promotes the construction of drug information traceability system。Vaccine、Anesthesiologically、Psychiatric drugs、Pharmaceutical Easy Poisonous Chemicals、Blood products and other key products should take the lead in establishing a drug information traceability system。

Opinion requirements,My stake betting appPharmaceutical listing license holder、Production Enterprise、Business Enterprise、Use unit to establish a drug traceability system through informationization,Timely and accurate record、Save the drug traceability data,Form the data chain of interconnected drugs traceability,Implementation of drug production、Circulation and use of the entire process of use can be checked、The whereabouts can be chased; effectively prevent illegal drugs entering legal channels; medicines that ensure quality and safety risks can be recalled、Responsibility can be held accountable。

Clear opinion,Provincial (district、City) The drug supervision and management department can formulate planning and implementation planning in accordance with the actual supervision.,Pharmaceutical dosage type、Category step by step promotes the construction of drug information traceability system。Vaccine、Anesthesiologically、Psychiatric drugs、Pharmaceutical Easy Poisonous Chemicals、Blood products and other key products should take the lead in establishing a drug information traceability system; basic drugs、Medical Insurance Reimbursement Drugs and other products that consumers generally pay attention to establishing a drug information traceability system as soon as possible; other drugs are gradually incorporated into the drug information traceability system。

The opinion also puts forward,To prepare a unified information traceability standard。Combining the actual needs of the construction of the pharmaceutical information traceability system,State Drug Administration Plan to establish a drug information traceability standard system,Clear basic requirements,Publishing Traceable System Construction Guide、Uniform drug traceability encoding Stake Sports Bettingrequirements、Data and exchange standards。

To build an information drug traceability system。Drug information traceability system is a drug listing license holder、Production Enterprise、Business Enterprise、Use unit、Drug Supervision and Management Department、Consumer and other retrospective related parties related to drug quality and safety,Through informatization means,Production for drugs、Circulation and use information to track information、The organic whole of traceability。Drug listing license holders and manufacturers should fulfill the responsibility of drug information traceability management,According to the requirements of unified drug traceability coding requirements,The unique traceability logo for the sales of the packaging unit at all levels,To realize information traceability。My stake betting appPharmaceutical listing license holders and manufacturers when they are selling drugs,It should provide relevant traceable information to downstream companies or medical institutions,To verify feedback from downstream enterprises or medical institutions。Drug listing license holders and manufacturers must be able to timely、Accurately obtain the circulation of the medicines produced、Use the entire process information。

To promote traceability information interconnection。The State Drug Administration establishes a national drug informatization and traceability collaborative service platform,Continuously improved drug traceability data exchange、Sharing mechanism。

To expand drug traceability data value。Drug supervision and management Stake Sports Bettingdepartments at all levels build a big data supervision system based on the drug information traceability system,Innovative drug safety supervision means,Explore the informationization of the entire process of implementing the medicine、Intelligent supervision,Improve the risk early warning mechanism。

To establish a data security mechanism。Drugs trace the relevant parties from the system、Technical guarantee for the reality of drug traceability data、Accurate、Full、cannot be tampered with and traceable。Drug traceability data records and vouchers should be not less than five years。It should be clear that the full -time department and personnel are responsible for the pharmaceutical traceability data management,Make sure data security、Prevent data leak。

Drug supervision and management department shall guide and supervise the construction of the traceability system。The drug supervision and management department shall fulfill the guidance and supervision responsibility,According to regulatory needs,Construction traceability supervision system。Provincial drug supervision and management department shall be in accordance with relevant laws、Regulations and standards,Combined with the actual administrative area,Develop specific measures,Determine responsibility at all levels。