INTERPRETATION OF STANDARDS AND SPECIFICATIONS CHINA - DRUG & VACCINE TRACEABILITY

I. INTERPRETATION of China’s drug traceability standards

The Vaccine Administration Law of June 2019 tasked China’s National Health Commission (NHC) with establishing unified traceability standards and specifications for vaccine products. Two months later, the revised Drug Administration Law tasked the National Medical Products Administration (NMPA) with establishing unified traceability standards and specifications for drug products.

 

As a result, China has adopted 10 drug traceability standards and specifications to guide relevant parties to jointly build a national Drug Traceability Information System.

 

The move helps to break down barriers between various independent systems and companies by unifying drug traceability code requirements, standardizing the basic technical requirements for drug traceability systems, defining the content and format of information companies are required to record during the traceability process, and outlining data exchange requirements.

It is the responsibility of all participants in the drug supply chain to work together to build a traceability for drugs and vaccines sold and used in China that meets these 10 standards. These standards can be divided into three categories:

 

A. Drug Traceability – Basic & General Standards

The first category “Basic and General Standards”, put forward the general requirements for building the Drug Traceability Information System, drug traceability code coding requirements, and basic technical requirements for the drug traceability system in the below three (3) standards:

Guidelines for the construction of a drug traceability information system: These guidelines explain the basic requirements of all parties involved in the construction of China’s drug and vaccine traceability system.

Coding requirements of a drug traceability code: This includes the definition of drug traceability codes, coding principles and objectives, basic requirements, composition requirements, as well as the requirements for carriers, code issuing agencies, drug marketing license holders and manufacturing enterprises.

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Basic technical requirements for a drug traceability system: These include general, functional, storage, safety, operational and maintenance requirements.

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B. Vaccine traceability data and exchange standards

The second category “Vaccine traceability data and exchange standards”, considers only the separate legislation of vaccines and the particularity of vaccine management, from its production to distribution, and till its end-use. This category-specify requirement for traceability data collection, storage, and exchange for vaccines, including two 2 standards:

Basic data set for vaccine traceability: This standard specifies the classification of the basic data set for vaccine traceability, the relationship between the data set and the producer of the vaccine traceability data, and the content of the data set related to the construction of the vaccine information traceability system. All parties are required to collect and store traceability data that meet this standard.

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Basic technical requirements for vaccine traceability data exchange: All participants are required to collect and store data in accordance with this standard, which specifies the methods, data format, data content and safety requirements for data exchange in the vaccine information traceability system.

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C. Drug (exclude vaccine) traceability data and exchange standards

The third category “Drug (exclude vaccine) traceability data and exchange standards”, specific requirements for traceability data collection, storage, and exchange from the production, distribution, use, and consumer inquiries of drugs (excluding vaccines), including five (5) standards:

Basic data set for drug marketing license holders and manufacturing enterprises: This standard specifies the content of basic data sets that drug marketing license holders and manufacturing companies are required to collect, store and provide to the drug traceability system.

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Basic data set for drug distribution enterprise traceability: This standard specifies the content of the basic data set that drug distribution companies are required to collect, store and provide to the drug traceability system.

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Basic data set for drug user unit traceability: This standard specifies the content of the basic data set to be collected at the drug user unit level, stored and provided to the drug traceability system.

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Basic data set for drug traceability consumer inquiry: This standard specifies the basic drug traceability data that consumers can access through the drug traceability system.

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Basic technical requirements for drug traceability data exchange: This standard specifies the method, data format, data content, and safety requirements for exchanging drug traceability data in the Drug Traceability Information System.

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II. KEY CONCEPTS - CHINA’S DRUG TRACEABILITY SYSTEM

Drug traceability provides information on the full life cycle of a drug by identifying and recording the journey of the drug throughout its production, distribution and use.

 

The Drug Traceability Information System is the tool that drug marketing license holders, manufacturing companies, operating companies, users, regulatory agencies and social participants, etc., use to obtain this information.

 

The basic components of China’s Drug Traceability Information System include the Drug Traceability System, the Drug Traceability Collaborative Service Platform and the Drug Traceability Supervision System:

 

Drug Traceability System

The Drug Traceability Information System regulates the collection, storage and exchange of traceability information related to the entire process of drug production, circulation and use in accordance with the requirements of drug traceability standards and specifications.

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Drug Traceability Collaborative Service Platform

This platform acts as a “bridge” and “hub” of the information system, mainly providing the following four services: basic information collection and distribution to ensure the consistency of the basic information in each system; recording of codes and setting coding rules to ensure the uniqueness of traceability codes; address resolution to accurately locate the drug traceability system where each traceability code is located; and public inquiry services with a unified drug traceability information query entry.

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Drug Traceability Supervision System

The Drug Traceability Supervision System was built by regulatory authorities to help relevant departments to carry out daily inspections, coordinated supervision and other work. It includes national and provincial drug traceability supervision systems, with traceability data acquisition, data statistics, data analysis, intelligent early warning, and recall management, among other functions.

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Drug Traceability Code

The Drug Traceability Code (DTC) is the unique code used to identify each salable unit of a drug. It consists of numbers, characters and symbols. The DTC is like the electronic ID number of the drug that is used to unlock the corresponding traceability data. The DTC includes the Drug Identification Code and Production Identification Code, which together are used to uniquely identify each unit.

The DTC is encoded in certain data carriers such as one-dimensional and two-dimensional barcodes, RFID tags, etc., assigned to each unit. The DTC is human-readable or can be scanned.

The Drug Identification Code is a unique code used to identify the marketing authorization holder, manufacturing enterprise, generic drug name, dosage forms, dosage and packing specifications, etc.

The Production Identification Code is used to identify processing data during manufacturing. It should consist of at least a drug serial number, batch lot number, manufacturing date and expiry date.

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Nation Drug Identification Code

The National Drug Identification Code is used to uniquely identify the drugs corresponding to the marketing authorization holder, manufacturer, generic name, dosage form, as well as preparation and packaging specifications. It is generated after the marketing authorization holder and the manufacturer record the information related to the drug packaging specifications on the Drug Traceability Collaborative Service Platform, which will then disclose the information for industry use.

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Basic Data Set

The basic data set is the minimum data set defined in the system construction, which can be identified and processed by computer. It contains the most basic and core data items. It is used to standardize the classification and content of the basic data set that each participant needs to collect, store and provide in the process of drug traceability. When the standard user carries out the actual application and exchange according to the standard, relevant data items can be supplemented or expanded based on the basic data set according to the user’s needs.

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