The reevaluation scheme of safety and effectiveness of traditional Chinese medicine injection has been formed

[China Pharmaceutical network industry trends] the re evaluation of traditional Chinese medicine injection has actually started in 2009, but the effect is not good for many years In the past two years, the State Food and drug administration, while strengthening the monitoring of adverse reactions of traditional Chinese medicine injections, has repeatedly revealed that it is necessary to promote its re evaluation On February 27, 2017, Bi Jingquan proposed to start the re evaluation of the safety and effectiveness of traditional Chinese medicine injection After the two traditional Chinese medicine injections were asked to stop selling and recall before the National Day holiday, on the first day after the National Day holiday, the State Food and Drug Administration once again made a voice on the safety and effectiveness evaluation of traditional Chinese medicine injections Wu Zhen, deputy director of the State Administration of food and drug administration, said at a press conference held on the morning of September 9 that traditional Chinese medicine injections are products of a specific historical period, the clinical validity data and safety data are incomplete, and everyone is worried about the safety The State Administration of food and drug administration has also been paying attention to traditional Chinese medicine injections, and the State Administration of traditional Chinese medicine injections and food and drug administration is also closely observing, and those who go out Now the adverse reactions will take decisive measures to protect the public drug safety to a large extent According to the opinions on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices (hereinafter referred to as the "opinions") issued by the general office of the CPC Central Committee and the general office of the State Council on October 8, the CFDA will re evaluate the listed drugs injection, and strive to basically complete it in 5 to 10 years Wu Zhen said that according to the requirements of the document "opinions on the reform of drug and medical device review and approval system" issued by the State Council in August 2015, the safety of traditional Chinese medicine injection needs to be re evaluated This re evaluation scheme has been preliminarily formed, but it is still under discussion in the industry, and opinions may be sought in the near future Referring to the specific evaluation methods of traditional Chinese medicine injections, Wu Zhen said that the re evaluation of traditional Chinese medicine injections is more difficult than that of chemical injections, because the ingredients in them are not as clear as those of chemical drugs Traditional Chinese medicine injection should not only evaluate the safety, but also evaluate the effectiveness The effectiveness is the fundamental attribute of the drug If there is no effect, the drug will have no value Therefore, the evaluation of traditional Chinese medicine injection should first evaluate the effectiveness, and at the same time review the safety The next step is to develop specific evaluation methods Article 11 and Article 25 of "opinions" all point to injection, with clear requirements: if the oral preparation can meet the clinical needs, the injection preparation will not be approved for listing; if the intramuscular injection preparation can meet the clinical needs, the intravenous injection preparation will not be approved for listing; it is expected to use 5-10 years to re evaluate the drug injection that has been listed In fact, the re evaluation of traditional Chinese medicine injection has been started in 2009, but its effect is not good for many years In the past two years, the State Food and drug administration, while strengthening the monitoring of adverse reactions of traditional Chinese medicine injections, has repeatedly revealed that it is necessary to promote its re evaluation At the 28th meeting of the Standing Committee of the 12th National People's Congress held on June 22, 2017, Bi Jingquan, director of the State Food and drug administration, mentioned in the report that the basic research on the safety and effectiveness of injections, especially those that were approved to be listed in the early stage and produced with traditional Chinese medicine as raw materials, is weak, and some production enterprises cut corners, use fake and inferior raw materials and change production processes without authorization, It has seriously affected the safety and effectiveness of drugs, and will promote the effectiveness and safety evaluation of listed traditional Chinese medicine injection by stages and batches According to the national ADR monitoring annual report (2016), in 2016, the national ADR monitoring network received a total of 102000 serious ADR / event reports, 5.5% of which were Chinese medicine; in the ADR / event reports, 1.507 million suspected drugs were involved, 16.6% of which were Chinese medicine; From the aspect of dosage form and administration route involved in the report, the proportion of traditional Chinese medicine injection is relatively high, and the proportion of intravenous injection is 53.2% The report also mentioned that the State Council requires the establishment of a monitoring system for the direct reporting of adverse reactions by manufacturers and the promotion of the effectiveness and safety evaluation of listed traditional Chinese medicine injections by stages and batches Before that, Bi Jingquan also disclosed this information publicly for many times On February 27, 2017, Bi Jingquan proposed to start the reevaluation of safety and effectiveness of traditional Chinese medicine injection At the launch ceremony of "national drug safety month" in October 2016, he also publicly emphasized this work Former title: General Administration of food and Drug Administration: the reevaluation scheme for the safety and effectiveness of traditional Chinese medicine injection has been preliminarily formed We will teach you to use app (Pharma) in the whole process and seize the opportunity of pharmaceutical machinery