Note that there is great progress in the evaluation of chemical injection consistency!

[pharmaceutical network industry trends] recently, it was reported that the formal document for the consistency evaluation of generic injection will be released at the end of this year As soon as the news came out, it attracted the attention of the market After all, the continuous promotion of the consistency evaluation process of generic drugs is directly related to the vital interests of enterprises and patients According to data, as of January 1, 2018, there are 31289 approval numbers of chemical generic drug injections approved by the drug review center of the State Food and drug administration, involving 820 varieties of 748 pharmaceutical companies Among them, there are more than 100 manufacturers of 24 varieties and more than 3 manufacturers of 456 varieties All of the above indications are after the State Food and Drug Administration issued two documents on October 15: technical requirements for conformity assessment of quality and efficacy of chemical injection generic drugs (Draft for comments) and application requirements for conformity assessment of quality and efficacy of listed chemical injection generic drugs (Draft for comments) After a long wait-and-see evaluation of injection consistency in the industry, great progress has been made In fact, as early as December 22, 2017, the former State Food and Drug Administration issued the technical requirements for conformity evaluation of listed chemical generic drugs (injections), which indicated that the state had begun to lay out the work of conformity evaluation of chemical injections But after that, there was no breakthrough for a long time Until March 29, 2019, the drug evaluation center of the State Food and Drug Administration issued the catalogue of chemical generic reference preparations (the 21st batch), involving 327 varieties in total, the pace of work began to accelerate In addition, for the first time, there are 224 injection reference preparations, accounting for 68.5% In fact, the formal document for the consistency evaluation of generic drug injections will be released at the end of this year It is generally believed that in the future, the volume purchase of drugs will include the over evaluated drug injections Most of the market will be occupied by the drugs that have been evaluated step by step, and the industry concentration will continue to improve Because, according to the previously issued documents, if there are more than three manufacturers of the same kind of drugs that have passed the consistency evaluation, they will no longer choose the varieties that have not passed the consistency evaluation in the centralized purchase of drugs, and the manufacturers corresponding to these varieties must strive to pass the consistency evaluation as soon as possible before they are expected to squeeze into the first batch of national centralized purchase teams Once it fails to enter the first batch of centralized procurement team, it will hand over the domestic market to its peers It is reported that as of the end of September, there were 434 acceptance numbers involving 120 varieties, 79 of which were in the 2017 national medical insurance catalog In terms of the number of enterprise applications, Kelun pharmaceutical, Qilu pharmaceutical, China biopharmaceutical, Yangzi River, hausen pharmaceutical, Hengrui pharmaceutical and other leading enterprises in the industry rank first At present, only azithromycin for injection has passed the consistency evaluation according to the supplementary application, and the other 9 over evaluated injection varieties have been approved for production according to the new registration classification of chemical drugs (deemed to have passed the consistency evaluation) On the whole, consistency evaluation is a reshuffle of China's generic drugs, which will comprehensively improve the quality of China's generic drugs If strictly implemented in place, it is expected to promote the upgrading of domestic chemical generic drug projects from "generic standard" to "generic quality", establish and improve the risk quality control system of injection generic research and development, and comprehensively improve the quality level of injection generic drugs in China Some insiders said that once the injection consistency evaluation work is started in the future, the industry will usher in a round of fierce elimination of production capacity, a number of small and medium-sized enterprises may go out of business, and high-quality leading enterprises with technology and cost advantages will have a better chance to win.