The introduction of policies is often a process of interest game. In the process of policy formulation, the interests of all parties should be balanced, that is, to make the policy objective and reasonable, and to avoid too much resistance in the implementation.
The drug electronic supervision code management system is aimed at supervising the state of drugs in the production and circulation process, realizing product traceability and management of regulatory departments and production enterprises, and safeguarding the legitimate rights and interests of drug manufacturers and consumers. The purpose is to rely on the national drug administration network platform covering the whole country to complete product status inquiry, traceability and management functions. The whole process from production, distribution, transportation, storage to distribution to medical institutions is under the supervision of the drug regulatory department.
Inquire about the production, operation, inventory and flow of each box, box and batch of key drugs in real time, and can quickly trace and recall in case of problems. Realize information early warning and terminal mobile law enforcement. Drug supervision and inspection personnel can conduct timely inspections on the spot conveniently through mobile law enforcement systems, such as through the Internet, or through mobile phones.
In 2006, the former State Food and Drug Administration began to implement electronic drug supervision in order to strengthen the electronic supervision of drugs, improve the level of public drug safety, and realize the supervision of all varieties and processes of drugs.
Since November 1, 2007, narcotic drugs, first-class psychoactive drug preparations, and small-package APIs have all been included in electronic supervision.
Since November 1, 2008, the second category of psychotropic drugs, traditional Chinese medicine injections, blood products, and vaccines have all been included in electronic supervision.
On June 17, 2010, the State Drug Administration (SFDA) issued the "Notice on Doing a Good Job in the Electronic Supervision of All Varieties of Essential Drugs", stating that all bidders producing essential drug varieties must join before March 31, 2011. The drug electronic supervision network shall make preparations for code assignment, verification and write-off, and enterprise's own early warning processing according to regulations. That is to say, after narcotic drugs, psychotropic drugs, blood products, vaccines, and traditional Chinese medicine injections, 307 essential drugs will also be fully included in the scope of electronic supervision.
On April 1, 2011, according to the "Guiding Opinions on Establishing and Standardizing the Procurement Mechanism of Essential Medicines for Government-run Primary Healthcare Institutions" recently issued by the General Office of the State Council, provinces are not allowed to purchase unlisted medicines on the electronic supervision network and unify the barcodes of essential medicines information. Identify essential medicines supplied by the business. By then, the smallest packages of medicines produced by 2,152 pharmaceutical manufacturers will be coded, and all essential medicines will have unique medicine "electronic ID cards".
Before the end of February 2012, all varieties of national essential drugs were included in electronic supervision. According to media reports, as 307 essential medicines are gradually added to electronic supervision, electronic supervision involves about 35,000 approval numbers, involving more than 3,000 pharmaceutical companies, covering 70%-80% of the marketed varieties.
On January 4, 2015, CFDA issued an announcement requiring all domestic pharmaceutical preparation manufacturers and imported pharmaceutical manufacturers to be included in the China Drug Electronic Supervision Network before December 31, 2015. At the same time, all drug wholesale and retail enterprises must be connected to the Internet. So far, all medicines in China have been included in the scope of electronic supervision.
In the past year, the number of companies and drugs that have entered the network has increased rapidly, and the amount of stored regulatory code data has increased by nearly four times.
On February 20, 2016, the CFDA announced that it would suspend the electronic supervision of drugs and solicit opinions on the revised version of the "Good Manufacturing Practice for Drugs". In the revised version of the document, all the contents about electronic supervision of drugs are either deleted or modified. Its basic direction is to build a drug traceability system in the future, so that the source of the drug can be traced, the whereabouts can be traced, and the responsibility can be held.
On February 22, 2016, Ali Health stated in its "Inside Information Regarding the Future Operation and Maintenance of Drug Electronic Regulatory Network Business" that since the release of the clarification announcement, the company has further discussed the matter with the Food and Drug Administration and established A joint working group was formed to discuss the transition of the Drug Electronic Regulatory Network.
On February 23, 2016, Ali Health published an article on its official WeChat account, saying that Ali Health is willing to hand over the established drug electronic supervision network system to the State Food and Drug Administration, and is happy to see a drug traceability supervision system that is more in line with the laws of the market economy. .
On February 29, 2016, Bi Jingquan, director of the State Food and Drug Administration, responded at a press conference that enterprises should assume the main responsibility for building a product traceability system. The formulation of any policy measures must fully consider its economy, effectiveness, fairness and legitimacy, fully listen to the opinions of all sectors of the society, and obtain the understanding, cooperation and support of the regulatory target.
This is also the reflection and experience of the supervision department on the experience and lessons of the electronic supervision code dispute. It is necessary to properly handle the problems involving the public's drug inquiries, the vital interests of enterprises and the government's performance of supervision responsibilities in accordance with this principle, and properly handle this historical problem.