After the evaluation of injection consistency, only 30% of 1000 enterprises are left

[industry trends of pharmaceutical network] on November 15, the technical requirements for conformity assessment of quality and efficacy of chemical injection generic drugs (Draft for comments) and the application data requirements for conformity assessment of quality and efficacy of listed chemical injection generic drugs (Draft for comments) will end the consultation This means that the evaluation of injection consistency that the industry pays attention to for a long time is about to start According to the data, at present, the domestic chemical injection accounts for 72% of the injection, and the two categories of generic drugs - solid preparation and injection account for more than 80% of the public hospital market, while the injection accounts for about 2 / 3 In 2018, the sales volume of terminal drug injection in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as "China's public medical institutions") reached RMB 615.157 billion Compared with oral solid preparations, the evaluation of injection consistency has been slow At present, only 12 injection companies in the industry have passed or deemed to have passed the consistency evaluation In fact, as early as October 2017, the state issued the opinions on deepening the reform of review and approval system and encouraging the innovation of pharmaceutical medical devices, which put forward that "according to the progress of pharmaceutical science, reevaluate the marketed pharmaceutical injections, and strive to complete in about 5 to 10 years" In December 2017, the drug review center of the State Drug Administration (the "drug review center") also released the technical requirements for conformity assessment of listed chemical generic drugs (injections) (Draft for comments) Behind the slow progress of the policy, it is related to the difficulty of injection consistency evaluation and high safety requirements However, from this year's point of view, the promotion of the whole chemical injection consistency evaluation work has shown a trend of acceleration Prior to the end of this consultation, CDE also issued a notice on Soliciting Opinions on the technical requirements for conformity evaluation of quality and efficacy of generic drugs (special injections) for chemical injection (Draft), which will end on December 5 At present, there are more than 1000 injection enterprises in China Some insiders predict that only 20% - 30% of 1000 enterprises will be left after passing the consistency evaluation Therefore, the relevant departments of the state have been cautious and cautious in the evaluation of injection consistency, but for the dual consideration of social and economic benefits, it must be solved as soon as possible After the successful implementation and experience of the consistency evaluation of solid preparations, the consistency evaluation of injections has become a national will to improve the quality of drugs and solve historical problems, which is also a hot topic at present It is reported that some injection manufacturers have begun to evaluate the layout consistency As of October 18, 2019, there are relatively more enterprises applying for conformity assessment of 7 drugs, including ceftriaxone sodium for injection, parecoxib sodium for injection, ambroxol hydrochloride injection, esmeralazole sodium for injection, doxofylline injection, doxoxacetamide injection and dextromethomiil hydrochloride injection, with the number of enterprises reaching more than 5 Behind the acceleration of the injection consistency evaluation, it is considered as the foreshadowing for the further promotion of the follow-up on-line procurement policy The industry also tends to believe that the earlier an injection company applies for conformity assessment, the more favorable it will be in the industry competition In addition, the evaluation progress of enterprises with high quality injection production line may be faster than that of competitors, which can take the lead in future centralized mining.