Heavy weight: Drug traceability code redeployed! What are the new requirements?

On April 28, the official website of the State Drug Administration released the announcement of "Publishing Guidelines for the Construction of Pharmaceutical Information Traceability System Coding Requirements for Pharmaceutical Traceability Code Two Information Standards (No. 32, 2019)", formally announcing that the system of drug traceability regulatory code will be deployed completely. In September 2016, the former State Food and Drug Administration issued "Opinions on Promoting the Improvement of Traceability System for Food and Drug Producers and Operators". The content proposed that food and drug producers and operators should assume the main responsibility for the construction of food and drug traceability system and realize their production and operation. Sources of products can be traced, whereabouts can be traced. However, since the previous opinions have not clearly unified the standards and implementation rules of traceability system, the standardization and standardization of drug traceability system has attracted much attention of the industry.

The Guidelines for the Construction of Pharmaceutical Information Traceability System clearly indicate that the drug information traceability system should include drug traceability system, drug traceability collaborative service platform and drug traceability supervision system. In addition, the drug traceability system should include traceability information in the whole process of production, circulation and use of drugs, and has the functions of collecting, storing and sharing traceability information. It can be divided into two categories: self-built traceability system of enterprises and traceability system provided by third-party organizations. Industry insiders believe that if the enterprise's own traceability system meets the regulatory policy requirements, it is allowed to continue to use the enterprise's self-built traceability system; if the enterprise's self-built traceability system fails to meet the regulatory policy requirements, it can upgrade itself and seek third-party platform access.

According to the requirements, information technology enterprises, industry organizations and so on can act as third parties to provide professional services of drug traceability in accordance with relevant regulations and standards. Relevant coding agencies should have clear coding rules, and assist drug licensing holders and manufacturers to file their basic information, coding rules, drug identification codes and related information with the collaborative platform to ensure the uniqueness of drug traceability codes.

This policy is clear that "drug traceability code" is the code used to uniquely identify drug sales and packaging units at all levels; and "drug identification code" is used to identify a specific drug that corresponds to the Licensee holder, manufacturer, generic name, dosage form, preparation specifications and packaging specifications. Uniqueness code for drugs. In addition, the policy emphasizes that the data exchange among drug traceability system, collaboration platform and drug traceability supervision system should conform to the relevant technical standards of data exchange formulated by the State Drug Administration. It is not difficult to predict that speeding up the construction of information-based drug traceability system will be conducive to sharing drug traceability information, realizing traceability of drug sources and traceability, and ensuring recallability and accountability of counterfeit drugs and problematic vaccines in case of quality and safety problems. Just three days ago, the Secretariat of the Leading Group on Medical Reform of the State Council and the State Health Commission held a conference on typical experiences of deepening drug reform. The conference clearly will further improve the implementation of the national essential drug system, accelerate the construction of drug information traceability system, and clarify "vaccine, narcotic drugs, psychotropic drugs, drug-prone chemicals". Key products such as blood products should take the lead in establishing the traceability system of drug informatization.

 Obviously, as the main body of the construction of drug information traceability system is enterprises, enterprises not only have to pay for hardware facilities such as computers, scanners, encryption equipment, but also pay for software development and post-maintenance, as well as the cost of hiring relevant professionals. In order to prevent abuse of relevant data, enterprises, as the main body of the traceability system, should adopt effective data security storage technology to prevent data leakage. They should be able to verify the integrity and validity of stored data, prevent unauthorized users from illegally obtaining and modifying data, and record the modification behavior and content of authorized users. And disaster recovery function.