Nine reference formulations were not considered, including Torasemi tablets.

On June 30, CDE released the 30th batch of chemical generic reference preparations, including 171 reference formulations, revised 1 reference formulation, and 9 failedIn January this year, the CDE formula included a list of the first batch of reference formulations that had not been considered, and 29 of the rules had not been considered; Together with the nine rules, a total of 42 rules have not been consideredthe nine rules that were not considered by theincluded: bemetronlythin eye drops (0.03% (2.5 ml), Torasemi tablets (4 mg, 8 mg), bear deoxybiliacid tablets (0.1 g), cabeanuterine injections (1 ml: 100 ?g), epinephrine injections, hydrochloric acid injections (0.1 mg/ml(1 ml)Of these, a total of three epinephrine injections failed to be consideredon the reasons for the failure to pass the review, the licensee Chishou Pharmaceutical Co., Ltd.'s Bemeprosin eye drops (0.03% (2.5 ml) products because of the published reference formulation concentration consistent, only different loading, domestic published reference preparations to meet the needs, the review was not adoptedThis product has been issued as a reference to the 3 ml: 0.9 mg, 5 ml: 1.5 mg (25-21, 25-22) imported by Allergan Inthe holder TianMitsubishiCo., Ltd.'s Torasemi tablets (4 mg, 8 mg), its specifications, usage and domestic listed products are inconsistent with the review of the failure to pass;licensee Ferring Inc's Caberbank injection (1 ml: 100 ?g), after a change in prescription, it is a storage advantage over pre-change prescriptions, and it is not recommended to use pre-change prescriptions as reference agents for consideration of failurethe licensee Medication International Systems, Limited (1 mg/10 mL), Richter Gedeon Nyrt Hungarian Grealda Pharmaceuticals (1 mg/1 ml), First Three Co., Ltd(1 mg/1 ml (0.1w/v)) epinephrine injections failed due to: Consistency Evaluation Expert Committee, to be published in the U.SOrange Book with RLD/RS logo products as analogThis product has no reference agent status, the review was not adopted, the epinephrine injection (0.1 mg/ml (1 ml)) was considered by the Consistency Evaluation Expert Committee, and the consideration was not adopted by the Expert Committee on Consistency Evaluation generic reference formulation is a reference for bioequivalence (BE) research In order to standardize generic review and consistency evaluation, optimize working procedures, strengthen service guidance, ensure fairness, fairness and openness, chemical generic reference preparations need to be selected The selection of reference formulations should be aimed at providing the public with high-quality generic drugs from its selection steps and the principles followed, the selection order of the original research drugs is: domestic listed drugs for research, foreign research enterprises determined by the audit or technology transfer production of drugs, drugs not imported original research drugs The original research drug refers to the first drug approved for listing at home and abroad, and has complete and adequate safety and effectiveness data as the basis for listing in cases where the original research drug ceases production or the original research drug is not suitable for reference preparation due to quality and other reasons, may choose to market the internationally recognized same-type medicine, the internationally recognized equivalent drug that has been approved for listing in the United States, Japan or the European Union, and the internationally recognized equivalent drug that has been approved for sale in China or is produced by technology transfer Internationally recognized generic drugs are generic strains that are approved for market in the United States, Japan or the European Union and have been granted the status of a reference agent , in addition, other drugs assessed by the State Drug Administration to be safe, effective and controllable .