State Food and Drug Administration: in the second half of the year, re evaluation of traditional Chinese medicine injection will be launched

[China Pharmaceutical network industry trends] on July 6, the national drug regulatory working conference was held Jiao Hong, director of the State Drug Administration, made clear when making specific arrangements for the work in the second half of the year, and will start the drug injection re evaluation The variety of traditional Chinese medicine injection is unique to China, and the number of varieties and approvals is far less than that of chemical and biological drugs It is reported that at present, there are nearly 140 varieties of traditional Chinese medicine injections in China, with nearly 1000 approvals The industry said that as soon as the State Food and Drug Administration released this news, a major reshuffle in the field of injection will begin According to the contents of the meeting, Jiao Hong mainly made three arrangements for the drug supervision in the second half of the year: first, simplify administration and delegate power, and deepen the reform of the review and approval system We will further improve regulatory regulations and systems, accelerate the review and approval of pharmaceutical and medical devices, continuously improve policies and measures for the consistency evaluation of quality and efficacy of generic drugs, and improve the quality and efficiency of review and approval We will start the reevaluation of drug injections and continue to do a good job in the registration and filing of cosmetics Second, we should strengthen supervision and crack down on violations of laws and regulations Strengthen the supervision during and after the event, focus on high-risk products such as vaccines, blood products, injections, implantable medical devices, do a good job in the field inspection of overseas R & D and production of imported medical devices, promote the "double random" full coverage of daily inspection, and make the inspection results all public We will strengthen the rectification of outstanding problems, crack down on the crimes of making and selling fake drugs on the Internet and illegal drug sales, carry out centralized rectification of Chinese herbal pieces, and continue to carry out special rectification actions against unlicensed operation and operation of unlicensed medical devices; Strengthen the implementation of responsibility, urge the enterprise to fulfill the responsibility of the whole product life cycle, establish the system of direct reporting of adverse drug reactions and adverse events of medical devices; strengthen the improvement of supervision ability, strengthen the quality management of review, inspection and inspection, accelerate the construction of reviewers and professional inspectors, and strengthen the use and management of licensed pharmacists Third, we need to strengthen services and comprehensively promote smart supervision and sunshine supervision We should accelerate the "Internet plus drug supervision", implement the electronic examination and approval, and accelerate the establishment of the electronic and general technical document management system for the drug, and promote the construction of the information system for the application of medical devices registration We will build a "drug supervision cloud" and strengthen the collaborative linkage of review and approval, inspection and testing, inspection and law enforcement and other business links We will continue to promote sunshine supervision, timely release inspection, spot check, punishment and other regulatory information, and take the initiative to respond to social concerns For the re evaluation of traditional Chinese medicine injection, the relevant national departments have been promoting In December 2017, technical requirements for conformity evaluation of listed chemical generic drugs (injections) (Draft for comments) were released; on March 15, this year, CDE solicited opinions on technical guidance for research and development of drug injections; on May 14, the State Food and Drug Administration issued the announcement on strengthening on-site inspection of registration application of chemical generic drugs No matter from the advance of preliminary work or the deployment in the second half of this year, we can see the determination of relevant departments to rectify the traditional Chinese medicine injection industry However, despite the efforts of the relevant departments of the state, the market scale of traditional Chinese medicine injection is still expanding According to the relevant data, the domestic injection Market maintained a growth trend from 2013 to 2016, with an annual compound growth rate of 6.7% By 2016, the domestic injection scale reached 757.7 billion yuan, an increase of 8.1% year on year According to the growth of 5% in 2017, some experts say that the market scale is about 800 billion yuan According to the promotion of the regulatory work of the relevant departments of the state and the expansion of its market scale, the industry will be more standardized and scientific development In addition, according to analysts, at present, 12 traditional Chinese medicine injection varieties have applied for conformity assessment of generic drugs, and 5 varieties have passed / deemed to pass the conformity assessment According to the work deployment of the State Food and Drug Administration in the second half of the year, these varieties will usher in more favorable results.