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

In order to promote the construction of the drug information traceability system and guide enterprises to carry out the specific implementation of drug traceability codes, on June 21, 2021, the official website of the State Food and Drug Administration released the "Drug Traceability Code Printing Specification" and "Drug Traceability Code Consumer Inquiry Results Display Specification" "Two informatization standards solicitation drafts.
This time the two informatization standard documents are issued to implement the "Opinions of the General Office of the State Council on Accelerating the Construction of the Important Product Traceability System" and the "National Medical Products Administration on Drug Informatization Traceability "Guiding Opinions on System Construction" and other document requirements
.

Two new members have been added to the drug traceability system standard family, which put forward specific requirements for the printing of drug traceability codes and the display of consumer query results of drug traceability codes.

Definition of Drug Traceability Code

(1) Drug traceability: refers to the activity of obtaining traceability information of the whole life cycle of drugs through recording and labeling, forward tracking and reverse traceability of the production, circulation and use of drugs
.

(2) Drug traceability system: It is an information system used by participants in the drug information traceability system to collect and store traceability information throughout the entire process of drug production, circulation and use in accordance with the requirements of quality management regulations, and is used to achieve traceability information collection and storage , And exchange
.

(3) Drug traceability code: a code used to uniquely identify a drug sales packaging unit, consisting of a list of numbers, letters and (or) symbols, just like the electronic ID number of a drug
.

It is the key to unlock the traceability data of medicines, and it is the necessary prerequisite and important foundation for the realization of "one item, one code, same code"

The development history of my country's drug traceability system supervision

The safety of medicines is of vital importance to people's health.
A medicine traceability system from production to sales terminals needs to be established urgently.
The State Food and Drug Administration has promoted the improvement of the medicine traceability system in an orderly manner
.

A review of the development history of my country's drug traceability system has gone through the following development stages:

1.
Start the construction phase

China began to require drug retrospective supervision in 2006.
At that time, the government found that the efficiency and proportion of recalling problem drugs through website announcements or news broadcasts were very low
.

The original SFDA commissioned CITIC 21st Century to be responsible for the construction and operation and maintenance of the special drug monitoring information network system.

(1) In January 2006, electronic supervision of narcotic drugs and first-class psychoactive drugs was implemented
.

(2) In October 2007, the special drug supervision network was basically completed to dynamically monitor the entire process of production, circulation, and storage of narcotic drugs and first-class psychoactive drugs
.

(3) In October 2008, the former State Food and Drug Administration issued the "Notice on Matters Concerning the Operation and Management of the Electronic Drug Supervision Network" (Guo Shi Drug Administration Office [2008] No.
585), requiring the realization of the spirit of the second category.
The dynamic monitoring of the production, delivery and circulation of medicines and some high-risk medicines to ensure the authenticity and traceability of medicines; since November 1, 2008, China has begun to monitor the “four categories” of high-risk products (blood products, vaccines, Chinese medicine injections and two Class psychoactive drugs) implement electronic supervision
.

(4) In May 2010, the "Notice on Electronic Supervision of Essential Medicines for Full Varieties" was released and implemented, expanding the scope of electronic supervision to 307 essential medicines
.

It is required that from April 1, 2011, for the varieties listed in the essential medicines catalog, those who have not been connected to the Internet and have not used the drug electronic supervision code for uniform identification, shall not participate in the bidding and procurement of essential medicines

(5) In January 2015, the "Announcement on Issues Concerning the Full Implementation of Electronic Supervision of Drugs by Pharmaceutical Production and Operation Enterprises" was issued, requiring that domestic pharmaceutical preparation manufacturers, imported pharmaceutical pharmaceutical manufacturers, and all pharmaceutical wholesale and retail All enterprises must be connected to the network, and all pharmaceutical preparations produced after January 1, 2016 must be coded
.

2.
Adjustment and rectification stage

(1) In January 2016, the State Council issued the "Opinions on Accelerating the Construction of the Important Product Traceability System", which clearly included "drugs" in the category of "important products" and put forward requirements for the "drug traceability system construction", namely " The main content is to promote the full range of drugs, the traceability and supervision of the whole process, and the construction and improvement of the drug traceability system
.

Unfortunately, due to the lack of initial procedures and many problems that need to be improved in technology and operation, January 2016 The electronic supervision code system that is being built hard has been sued by Hunan Yangtianhe Pharmacy against the drug supervision department, and the electronic drug supervision system has been questioned

(2) In February 2016, the CFDA formally issued an announcement, deciding to suspend the implementation of the "Announcement on the Full Implementation of Pharmaceutical Electronic Supervision by 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 State 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: to 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, use information technology to collect and retain information such as the source of raw materials, production processes, purchase and sales records, and 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 and improve the 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 operators 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 informatization standards, "Guidelines for the Construction of Drug Information Traceability System" and "Requirements for Drug Traceability Code Coding," 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 for 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 Order No.
31 of 2019) formally came into effect on December 1, 2019, and Article 12 clearly stipulates that "the country shall establish and improve the drug traceability system"
.

This special regulation highlights China’s implementation of the "four most stringent" highest requirements to ensure drug safety.

(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 Drug Traceability Data Exchange will be implemented on March 6, 2020
.

(7) In June 2021, the National Medical Products Administration (NMPA) issued a draft for the two standards of "Principles of Drug Traceability Code Printing" and "Specifications for Consumer Query Results Display of Drug Traceability Codes" 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
.

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