Critical situation of traditional Chinese medicine injection: National Bureau starts clinical reevaluation

Source: Cypress blue 2015-10-16 recently, cypress blue learned from the sources that the National Bureau has recently issued a work division table on the implementation of drugs and medical devices, and all four departments and bureaus have received tasks within their scope of responsibility Moreover, in the document, in addition to some projects, the National Bureau also lists the start-up time and completion time Under a strict schedule, it is estimated that all policies can be effectively implemented, implemented and implemented We think that the implementation documents of the State Administration pay special attention to three key points: 1 The clinical reevaluation of traditional Chinese medicine injections will be carried out Every year, the State Administration will publish the drugs with the most adverse reactions Many large varieties of traditional Chinese medicine injections are also the varieties with high adverse reactions Will the clinical reevaluation have an impact on these varieties? This deserves special attention 2 The quality of drugs, especially generic drugs, is improved, the performance registration standard is strict, the consistency evaluation is promoted, and non-compliance is not allowed to be re registered After this round of strict quality control, the overall quality of generic drugs has been greatly improved, but the key is to give high-quality domestic generic drugs at a price in the bidding 3 Starting from the market demand, it is reflected in the list of approval of encouraged and restricted drugs, which means that in the future, the drug companies should not blindly apply for varieties, but according to the market, they should not rush in, otherwise they will enter the list of application of restricted drugs, and their approval is far away According to the documents of the State Administration, the following are some noteworthy points sorted out by cypress blue: 1 In order to improve the drug approval standard, by the end of October 2015, the approval department will complete the adjustment of drug registration classification For drug registrants, it is necessary to pay close attention to the adjustment of drug registration classification, even if the application plan is adjusted 2 Comprehensively improve the quality of generic drugs From November 2015, improve the approval standard of generic drugs The original research drug shall be used as the reference preparation for the review and approval of generic drugs to ensure that the quality and efficacy of the newly approved generic drugs are consistent with that of the original research drug This means that the application for generic drugs starting next month must be based on the original research drug In September 2015, the consistency evaluation of basic drugs was launched, and in 2018, the consistency evaluation of oral preparations of basic drugs was completed If the conformity re evaluation of generic drugs is not completed within the prescribed time, no re registration is allowed 3 Pay attention to the quality of traditional Chinese medicine, especially the clinical evaluation of traditional Chinese medicine injection This measure has been implemented since September 2015 4 Launched in December 2015, the pilot drug marketing license holder system was started, and completed by the end of October 2017 5 The system that is now accepted by the provincial food and drug regulatory authorities and approved by the State Administration is changed to centralized online acceptance by the State Administration In case of non-compliance, the State Administration shall inform the materials that need to be supplemented at one time This reform measure will be completed by the end of December 2016 6 Before the end of December 2016, after entering the technical review procedure, except for new drugs and first generic drugs, in principle, the applicant is not required to supplement materials and make a decision of approval or disapproval 7 From September 2015, the application catalogue of restricted and encouraged drugs will be published regularly 8 It was launched in September 2015, and innovative drugs can be used for clinical trials at the same time with foreign countries The clinical data can be used in the application of new drugs For the approval of innovative drugs, the protection of subjects will be emphasized 9 Reform the examination and approval of medical devices, speed up the examination and approval of innovative medical devices, and improve the registration standards of medical devices, so as to be in line with international standards 10 Transfer the approval authority of some mature, safe and controllable medical devices to the Provincial Bureau 11 Pilot drug approval and purchase services, and purchase approval services from universities, scientific research institutions, etc.