Why stop drug electronic supervision code

Feb 23, 2016

Source: economic daily

Recently, the state food and drug supervision and administration bureau's announcement, the relevant provisions of the suspended drug electronic monitoring, at the same time as the drug supply quality management regulations (draft) to solicit opinions from the public. At this point, 8 years of drug electronic supervision system of service was halted.

From the perspective of the revised contents of the draft, cancelled enforce electronic supervision code and code and data upload, delete the "drug supervision on implementation of the electronic enterprises shall be conducted in accordance with the provisions, drug electronic monitoring code and code, and timely data uploaded to the Chinese drug electronic monitoring network system platform", and "the implementation of the electronic supervision of drugs, when sold, shall conduct code and data upload". At the same time, will be implemented "drug electronic supervision regulations" changed to "enforce the rules of the medicines back".

Learned, drug electronic supervision code, is a pharmaceutical packaging 20 digits barcode, can realize tracking in the whole process of the drug from manufacturing to the circulation of each link. In January of this year, the food and drug regulator via a drug electronic monitoring code found seven companies illegally recycled drugs.

There is no denying the fact that over the years, drug electronic monitoring code exposed problems and many, among them, the issues raised by the pharmaceutical enterprises input costs the most. According to understand, with over 540 stores in hunan's days and large pharmacy after accept drug electronic supervision code, need to purchase a sweeping code gun, keys, and follow-up, initial investment cost is as high as 12 million yuan. At the same time, many drug firms believe that ali health sole-source China drug electronic monitoring network, fair competition, information security problems cannot be guaranteed.

"This announcement is to implement the state council to strengthen the construction of product traceability system requirements, and give full consideration to the views of the industry to implement the electronic supervision code and demands." , said an official with the national food administration of drug safety related by the perfection of relevant laws and regulations, to vigorously promote the solution of the problems left over by history.

The personage inside course of study concern, if the electronic supervision code to entirely and drug safety supervision will be affected? In fact, suspended the drug electronic supervision code, does not mean that the lack of drug traceability system.

A draft amendment to the "drug-handling quality management norms", points out that pharmaceutical trading enterprises shall be in accordance with the relevant state requirements to establish drug traceability system, realize the drug sources available, go back, responsibility to investigate. At the same time, the enterprise shall set up to meet the requirements of the business process management and quality control computer system, realize the drug quality traceability. "You can see, the next step, drug traceability system will replace the electronic supervision code, assume the duties of the drug regulatory." The state food drug safety administration officials said.

Issued by the end of last year, the state council "about the opinions of the quickening construction of important product traceability system, clear requirements on the basis of implement of traceability management responsibility, strengthen the enterprise's main body responsibility, can check construction source, go back, responsibility can investigate the important product traceability system. While the current drug electronic supervision code system mainly by the food and drug supervision department. In the future, drug traceability system will give priority to, by the enterprise supervision department is only responsible for providing necessary guidance.

To be sure, the electronic supervision code relics is a foregone conclusion, but subsequent drug regulatory measures remains to be perfect. The personage inside course of study thinks, regulators should timely summing up the experience of the implementation of the electronic supervision code, improve supporting technology, reach the dual goal of traceability and supervision.