Ali may legally charge for electronic regulation of drugs.

Immediately after the emergency stop of the drug electronic supervision code, the State Food and Drug Administration issued an announcement to publicly solicit feedback on the “Opinions on Further Improving the Food and Drug Traceability System (Draft for Comment)”.

Electronic supervision will restart

On January 26, Yangtian and the CFDA announced that the drug electronic supervision code was illegal. On February 20, the International Food and Drug Administration immediately issued a notice to suspend the implementation of the drug electronic supervision code. In the "Drug Management Quality Management Regulations (Revised Draft) and Description" issued on the same day, in the revised draft of the drug GSP, a "drug business enterprise should establish a drug traceability system in accordance with relevant national requirements, and the drug source can be investigated. Going to chase, responsibility can be studied."

At that time, everyone said that they did not understand what was the drug traceability system. However, yesterday's consultation draft finally unveiled the traceability system.

The document puts forward that “establishing a food and drug traceability system is the main responsibility of the enterprise”. Therefore, what kind of system is established and how to do it is the matter of the pharmaceutical company itself, so the pharmaceutical companies are under great pressure in this regard.

For the establishment of a traceability system, the Exposure Draft proposes:

X. Encourage production and operation enterprises to use information technology to establish a food and drug traceability system. Encourage information technology enterprises as third parties to provide product traceability professional services for production and operation enterprises. Food and drug supervision departments at all levels shall not force food and drug production and operation enterprises to accept the traceability services of designated professional information technology enterprises.

XI. Support industry associations to organize enterprises to set up a retrospective information query platform to promote the interconnection and information sharing between associations, enterprises and governments.

Some analysts believe that although the document also indicates that the support industry associations organize enterprises to build a platform for information traceability query, but after all, lack of experience. The Exposure Draft proposes that “establishing a food and drug traceability system is the main responsibility of the enterprise” and “encouraging information technology enterprises to serve as third parties to provide product traceability professional services for production and operation enterprises”. In this context, Ali Health has many years of mature professional traceability services (electronic supervision) experience, coupled with many pharmaceutical companies in the past have been using Ali's pharmaceutical electronic platform for many years, and the registration of electronic regulatory codes installed by pharmaceutical companies The equipment and equipment for scanning code are matched with the Ali platform, so that the choice of Ali as a third party may become an important option or even the first choice.

In the past, the "China Drug Electronic Regulatory Network" was attached to the National Bureau. When Ali was responsible for operation and maintenance, he could not charge fees. However, Ali provided third-party drug traceability services, which can be justified. What should the pharmaceutical companies do? Give or not?

Drug management and hospitals must be fully docked

In this consultation draft, the National Bureau only proposed to establish a drug traceability system, repeatedly stressing that it is not mandatory. Apparently demanding easing, but if the policy background is large, the pharmaceutical companies are not loose.

This consultation draft should “implement the four most stringent requirements of food and drug safety” and the “Opinions of the General Office of the State Council on Accelerating the Construction of Traceability System for Important Products” (Guo Ban Fa [2015] No. 95). The goal of the [2015] No. 95 document is: By 2020, the planning standard system for retrospective system construction has been improved, and the regulatory system has been further improved; the national tracking system has basically formed a unified exchange mechanism, and the relevant departments, regions and enterprises have been initially realized. Traceability information sharing.

Among them, the requirements for the drug traceability system are: to promote the construction of drug traceability system. With the main content of promoting the whole variety of drugs, the whole process of traceability and supervision, we will build and improve the drug traceability system. On the basis of completing the electronic supervision of pharmaceutical preparations, it will be gradually extended to medicines such as raw materials (materials) and decoction pieces. We will do a good job in the full coverage of electronic supervision in the operation chain, promote the docking of the medical information system and the national drug electronic supervision system, and form a complete trace and supervision chain for the whole variety and the whole process.

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