Inventory of my country's drug traceability system regulatory policy release overview

(2) In February 2016, the CFDA formally issued an announcement, deciding to suspend the implementation of the "Announcement on the Full Implementation of Drug Electronic Supervision for Pharmaceutical Manufacturers" (2015 No.
1).
"Pause" draws a symbol that is difficult to confirm for himself
.

(3) In September 2016, the former State Food and Drug Administration issued the "Opinions of the General Administration on Promoting Food and Drug Manufacturers to Improve the Traceability System" (SFDA [2016] No.
122) to continue to promote the establishment of a drug traceability system Encourage drug manufacturers and operators to use information technology to establish drug traceability systems; encourage industry associations to organize companies to build drug traceability information query platforms, provide data support for drug regulatory authorities, provide data sharing for drug manufacturers and operators, and provide information inquiries for the public
.

(4) In February 2017, the Ministry of Commerce and other seven departments jointly issued the "Guiding Opinions on Promoting the Establishment of an Informatization Traceability System for Important Products", which put forward four major requirements for the establishment of a drug traceability system: consolidate and improve the circulation traceability system of Chinese medicinal materials, Upgrade and transform the central platform for the traceability management of the circulation of traditional Chinese medicinal materials to promote the information exchange and sharing of different drug traceability systems; promote the implementation of the main responsibility of the drug production and circulation enterprises, and use information technology to collect and retain information on the source of raw materials, production processes, purchase and sales records, etc.
, to ensure the traceability of drugs ; Expand the coverage of drug traceability supervision, and gradually realize the rapid traceability of all drugs from production, circulation to use; establish a sound drug traceability management mechanism
.
This specific guiding opinion further points out the direction for establishing, improving and advancing the construction of the drug traceability system, and has stronger operability
.

3) High-quality development stage

(1) In November 2018, the National Medical Products Administration officially issued the "Guiding Opinions on the Construction of Drug Information Traceability System", marking the re-emergence of the drug traceability system, and clearly requiring drug marketing license holders, manufacturers, and operations Enterprises and users use information technology to establish drug traceability systems, record and save drug traceability data in a timely and accurate manner, and form an interconnected drug traceability data chain, so that the source and destination of drug production, circulation and use can be checked and whereabouts can be traced, effectively preventing illegality Drugs enter legal channels to ensure that drugs that have quality and safety risks can be recalled and held accountable
.

(2) In April 2019, the former State Food and Drug Administration issued two information standards, "Guidelines for the Construction of Drug Information Traceability System" and "Requirements for Drug Traceability Code Coding", which dealt with the coding principles of drug traceability codes, coding objects, Basic requirements, composition requirements, basic carrier requirements, basic requirements for code issuing agencies, and basic requirements for drug marketing license holders and manufacturers have put forward specific requirements
.

(3) In August 2019, three standards were issued: Basic Vaccine Traceability Data Set, Basic Technical Requirements for Vaccine Traceability Data Exchange, and Basic Technical Requirements for Drug Traceability System, focusing on standardizing the technical requirements of the drug traceability system, and The construction of the vaccine drug traceability system provides scientific and technological support
.

(4) In December 2019, the new "Drug Administration Law" (Chairman's Order No.
31 of 2019) formally came into effect on December 1, 2019.
Article 12 made clear provisions on "the country establishes a sound drug traceability system"
.
This special regulation highlights China’s implementation of the "four most stringent" highest requirements to ensure drug safety.
It also fully demonstrates that after China has established and improved a drug traceability system in accordance with the law, it must also make solid progress, actively organize its implementation, and promote its implementation to be effective.

.

(5) In December 2019, the "Vaccine Management Law" (Chairman Order No.
30 of 2019) formally came into effect on December 1, 2019.
Article 3 also clearly stipulates: "The state implements the most stringent management system for vaccines.
Adhere to safety first, risk management, full-process management and control, scientific supervision, and social co-governance
.
" Specific requirements have been set for the establishment of a vaccine drug traceability system
.

(6) In March 2020, the State Food and Drug Administration issued the Basic Traceability Data Set for Drug Marketing Authorization Holders and Manufacturers, Basic Traceability Data Set for Drug Dealers, Basic Traceability Data Set for Drug Use Units, and Drug Traceability The five informatization standards of Consumer Inquiry Basic Data Set and Basic Technical Requirements for the Exchange of Drug Traceability Data will be implemented on March 6, 2020
.

(7) In June 2021, the National Medical Products Administration (NMPA) issued the drafts for the two standards of " Drug Traceability Code Printing Specification" and "Drug Traceability Code Consumer Inquiry Results Display Specification" to promote the drug information traceability system.
Construction and guiding enterprises to carry out the specific implementation of drug traceability codes will help to unify the printing, use and inquiry of drug traceability codes, and provide technical support for drug traceability
.

references

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About the author: Drip Sinan, male, senior engineer in biomedicine, based on the quality management of the biomedical industry, focusing on the biomedical industry
.