In the first half of this year, China's pharmaceutical intelligent supervision has achieved a good start!

[pharmaceutical network industry trends] recently, the pharmaceutical smart regulatory technology exchange training meeting was held in Beijing It was mentioned at the meeting that 2019 is the year of full implementation of intelligent drug supervision Since the first half of this year, the pharmaceutical information technology department has made new progress in building the Internet plus government service platform and the Internet plus supervision system, and the drug intelligence supervision has achieved a good start However, at present, it is still a time when the informatization work of drug administration is climbing and overcoming difficulties We need to continue to polish the bright spots of wisdom and strictly adhere to the bottom line of safety, so as to make the sense of access of the public, enterprises and regulators more sustainable and more secure Medicine is a special commodity, whose quality and safety are related to people's health In recent years, there have been many drug quality and safety incidents in China, which need to be supervised by relevant departments to ensure the safety of products So, what is smart regulation? According to the data, intelligent supervision refers to a management mode that widely adopts automatic and intelligent means, implements supervision, homeopathy supervision and intensive supervision, and exchanges "subtraction" of operation procedures and machines for "multiplication" of efficiency, which can realize the whole process and refinement of drug safety control and create a new mode of drug industry safety control At present, intelligent drug supervision mode is being promoted in many places For example, Jinhua launched the construction of intelligent supervision platform for drug production in the national market supervision system in 2015, which was officially put into use in May 2016 After more than three years of practical operation, Jinhua has built a complete and effective intelligent supervision system for drug quality whole process traceability + risk assessment The Chengdu Market Supervision Bureau has launched a pilot project of "Internet plus intelligent supervision" for drug retailers in the city As of June this year, the total number of drugstores in Chengdu's 22 districts (cities) using "Internet plus intelligent supervision" platform containing special drugs was 11088, with a coverage rate of 99% or more At this year's National Conference on drug supervision and administration, "vigorously promote intelligent supervision and continuously innovate supervision methods" was listed as one of the six key tasks The industry believes that the current policy environment for drug regulatory informatization has been formed, and smart supervision should be vigorously promoted On May 21, the State Food and Drug Administration issued the notice on accelerating the action plan of intelligent drug supervision, proposed 14 specific tasks such as the construction of drug supervision cloud, and explored the use of information technology to improve the supervision efficiency Under the guidance of the action plan, the informatization department of drug administration actively promotes the informatization work of the three sectors of drugs, medical devices and cosmetics On August 26, the newly revised Drug Management Law clearly stipulated that the state should establish and improve the drug traceability system, and that the use of information technology can effectively prevent fake drugs and substandard drugs from entering the legal channels, realize drug risk control and recall, which is an important measure to ensure the quality and safety of drug production and operation The vaccine management law will come into force on December 1 this year, and many of its provisions also involve "information" supervision For example, it is required to develop unified standards and specifications for vaccine traceability, establish a national vaccine electronic traceability collaborative platform, integrate the whole process of vaccine production, circulation and vaccination traceability information, and realize vaccine traceability; the vaccine listing license holders should establish a complete production quality management system, continue to strengthen deviation management, and use information-based means to truthfully record production and inspection All data generated in the process to ensure that the whole production process continues to meet legal requirements, etc It can be seen that the role of "information" in drug management is increasingly prominent However, it was also pointed out at the training meeting on the exchange of pharmaceutical intelligent regulatory technology that the overall basis of the current pharmaceutical regulatory information work is still weak We should use information-based means to strengthen the supervision of new pharmaceutical technology, new products, new formats and new business models, so that the regulatory capacity can catch up with the pace of pharmaceutical innovation At the same time, we should make good use of information technology to carry out fine supervision, real-time dynamic supervision, implement the requirements of information disclosure, and improve the transparency of supervision work It can be predicted that with the continuous efforts of relevant departments in drug regulatory information work, the drug regulatory model will be more "innovative" and "intelligent" in the future, which is conducive to further ensuring the traceability of drugs in China, ensuring the quality and safety of drugs, and building a protective wall for the rights and interests of consumers.