Billions of market waves, two major injection varieties are required to revise the instructions

[industry trends of pharmaceutical network] recently, the State Food and Drug Administration issued two successive announcements, requiring manufacturers of brain glycoside and carnosine injection and compound bone peptide injection to revise the instructions as required, and making relevant manufacturers report to the provincial drug regulatory authorities for filing before January 8, 2020 The revision requirements of these two injections include adding [warning words], adding or revising [taboo] and [precautions] on the basis of the original instructions, and clarifying the prohibition of compound osteopeptide injection for children It is worth noting that both cerebrosine and carnosine injection and compound osteopeptide injection published by the State Food and drug administration have been listed in the list of drugs for rational use In July this year, brain glycoside and carnosine injection appeared in the list of national key monitoring drugs for rational use In fact, in recent years, influenced by the trend of clinical rational drug use, many drugs in the key monitoring directory have been transferred out of the national medical insurance directory At the same time, the local regulatory authorities and medical institutions have also expressed their opinions on the key monitoring to avoid the occurrence of clinical abuse This time, the State Food and Drug Administration required to modify the two injection instructions, both requiring the addition of warning words Or it means that these two drugs will be greatly limited in clinical use in the future   It can be learned from the inquiry of the State Food and drug administration that there are four approval numbers of compound osteopeptide injection in China, involving two drug manufacturers, Changzhou Fangyuan Pharmaceutical Co., Ltd and Nanjing Xinbai Pharmaceutical Co., Ltd.; there are three approval numbers of compound osteopeptide for injection in China, involving Nanjing Xinbai Pharmaceutical Co., Ltd., Heilongjiang Jiangshi Pharmaceutical Co., Ltd and Hebei Zhitong biopharmaceutical unit Three pharmaceutical manufacturing enterprises The production enterprises of brain glycoside and carnosine injection include Jilin Zhenao Pharmaceutical Co., Ltd and Jilin Sihuan Pharmaceutical Co., Ltd It is reported that since 2019, the State Food and drug administration has released 22 amendments to drug specifications, involving 36 generic drugs and 13 injections Among them, the sales of seven injections, such as cerebrosine and carnosine, Salvia miltiorrhiza and ligustrazine, methylprednisolone (injection), cefoperazone and sulbactam, cefoperazone and tazobactam, amoxicillin and clavulanate potassium (injection), human immunoglobulin, exceeded 2 billion yuan Injection drug safety has always been highly valued by the state At present, there are more than 1000 injection enterprises in China In order to regulate the injection market order, the State Food and Drug Administration said it would start the re evaluation of drug injection In fact, the formulation of injection re evaluation standards is also continuing In 2017, the state issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices The State Food and Drug Administration will reevaluate the listed pharmaceutical injections, strictly control the transformation of oral preparations into injection preparations, and do not approve the listing of injection preparations if the oral preparations can meet the clinical needs In March 2018, the drug review center of the State Food and drug administration asked for opinions on the technical guidance on drug injection research and development In May 2018, the State Food and Drug Administration issued the notice on strengthening the on-site inspection of chemical generic injection registration application, which announced that: in order to strictly review and approve the drug injection and ensure the safety and effectiveness of drugs, the State Food and Drug Administration decided to strengthen the on-site inspection of chemical generic injection registration application On October 15, 2019, in order to promote the consistency evaluation of quality and efficacy of chemical injection generic drugs, the state successively issued two documents, i.e technical requirements for consistency evaluation of quality and efficacy of chemical injection generic drugs (Draft for comments), and application data requirements for consistency evaluation of quality and efficacy of listed chemical injection generic drugs   According to the summary of relevant policies in recent years, under the background of strengthening clinical rational drug use, reducing adverse reactions and "limiting transportation" and deepening structural adjustment, the publication of the national version of the catalogue and the implementation of auxiliary drugs in different regions will further squeeze the space of auxiliary drugs, among which immunomodulators, neurotrophic agents and some cardio cerebrovascular drugs are included in the catalogue Many, for some related medical institutions and pharmaceutical enterprises will have a greater impact Relevant enterprises should adjust their strategic layout ahead of schedule, increase R & D efforts and optimize product mix.