289 what products will be eliminated naturally?

Recently, the office of quality and efficacy consistency evaluation of generic drugs launched the column of quality and efficacy consistency evaluation of generic drugs on CDE website and released the basic information table of 289 catalog varieties of reference preparations, which covers 289 list of varieties of reference preparations, 169 of which have reference preparations, 26 of which are not recommended for reference preparations, 14 of which are not recommended for the time being without enterprise filing, 32 of which are under study, and the rest are other products without recommended reference preparations "Do not recommend reference preparation" double day: three kinds of products are eliminated, two kinds of products are clinical free The "no recommended reference preparation" is divided into five categories, which are "there are safety problems, the foreign market has been withdrawn", "domestic unique varieties, no effective approval number and no enterprise filing", "foreign OTC monograph active ingredients, pharmaceutical research should meet the requirements of the corresponding guiding principles", "no effective approval number and no enterprise filing" and "pharmaceutical research should meet the requirements of the corresponding guiding principles" There are two products of "existing safety problems, which have been withdrawn from the market abroad", namely phenolphthalein tablets and smectin capsules There are also two product specifications for "domestic unique varieties, no valid approval number and no enterprise record" They are anisodamine hydrobromide tablets (10mg) and berberine tannate tablets (50mg) There are 17 product specifications for "no valid approval number and no enterprise record" They are medroxyprogesterone acetate capsule 0.25g, dopahydrazine tablet 0.125g (0.1g: 0.025g) (levodopa: benzylhydrazine), loratadine tablet 5mg, diclofenac sodium sustained release capsule (I) 50mg and (III) 50mg, sustained release tablet 50mg, sustained release tablet (I) 50mg, sustained-release tablets (Ⅴ) 100mg, tegafur capsules 50mg and tablets 200mg, nifedipine sustained-release tablets (including Ⅱ) 30mg, metformin hydrochloride capsules 0.5g, loratadine hydrochloride capsules and tablets 5mg, levofloxacin hydrochloride capsules 0.5g and levofloxacin tablets 0.2g The above three product specifications are expected to be eliminated naturally In addition, products "not recommended temporarily without enterprise filing" are also expected to be eliminated naturally In addition, there are three products that "foreign OTC monograph active ingredients, pharmaceutical research should meet the requirements of the corresponding guidelines", namely calcium gluconate tablets, sodium bicarbonate tablets and vitamin B2 tablets OTC monograph active ingredients refer to the drugs that have been proved safe and effective for a long time after the indication is sold For the drugs listed in the OTC monograph system, they need not be approved by FDA, but they are required to comply with GMP and drug registration There are two products that "pharmaceutical research should meet the requirements of corresponding guidelines", namely, oral rehydration salt powder (I) and oral rehydration salt powder (II) These two products are all products in the list of exempted or simplified human bioequivalence test (be) varieties (Draft for comments) in 289 basic drug catalogue previously released by CDE "Three change products" don't get lucky! Consistency evaluation must be carried out according to the "three changes" guide For other products without recommended reference preparation, the remark of some products is "enterprises can conduct research and evaluation according to the" three changes "technical guide and select reference preparation" The so-called "three changes" technical guidelines refer to the Circular of the General Administration on the issuance of three technical guidelines including general considerations for the evaluation of generic drugs (oral solid preparations) in the quality and efficacy consistency evaluation of generic drugs (No 27, 2017), which includes general considerations for the evaluation of generic drugs (oral solid preparations) in the quality and efficacy consistency evaluation of generic drugs《 There are three technical guidelines: General considerations for the evaluation of modified drugs (oral solid preparations) and general considerations for the evaluation of modified base drugs in the evaluation of the consistency of quality and efficacy of generic drugs The author thinks that there are two common difficulties in the three technical guidelines: one is the scientificity, rationality and necessity of project approval Whether the bioequivalence test or clinical test can meet the requirements of the guidelines In order to change the pharmacokinetic behavior, the relative bioavailability study and clinical trial should be carried out with the reference preparation of the original research formulation, and the drug of the modified formulation should be studied with the reference preparation of the original research formulation ”If the indication and dosage of the reference preparation are the same, the bioequivalence test will be carried out with the modified specification drug and the reference preparation in the same dosage (the single dose does not exceed the maximum dose) As shown in Table 1, the office of quality and efficacy consistency evaluation of generic drugs has basically sorted out the "three changes" products, and the corresponding products must be evaluated in accordance with the "three changes" guide Among them, there is no "modified dosage form product" in the 289 catalog, but products with other dosage forms of the same chemical composition in the 289 catalog and reference preparations need to be vigilant If the 289 catalog product with reference preparations is approved, it will get price preference, and then the project mentioned in the "three modifications" guide will be very passive Table 1 Summary of the list of "three modified products" (data source: sensitive information) the filing information includes the real estate information, the real estate information is published, and the imported reference preparation is no longer needed "Under study" products mainly include "domestic unique varieties, which need further study", "narcotic drugs, special control" and "original research property audit, which has not been published yet" Among them, "the original research and real estate audit, not published yet" announced 7 product regulations of localization, among which valsartan capsule previously published the original research reference preparation listed in the EU has been withdrawn Domestic enterprises will not need to import foreign reference preparations after the release of the information on the localization of the original research drugs through the consistency evaluation Table 2 summary of the information of the original research and localization products (data source: sensitive information) > > the publication of the basic information of 289 catalog varieties reference preparation disclosed which products have faced natural elimination and which "three reform products" need to carry out projects according to the guidelines 289 catalog has only one year left Enterprises that actively compete for conformity assessment have gradually started to prepare for on-site inspection and wait for the approval of conformity assessment The enterprises that are still waiting for the work of the reference preparation are in fact semi abandoned It is worth noting that there are 289 catalog products with large sales scale, and many imported generic drugs are waiting for listing For example, the tablets of clopidogrel bisulfate declared by rambsi laboratory Co., Ltd and Dr redI laboratory Co., Ltd of India, the tablets of acarbose imported and declared by Shanghai Longde Medical Technology Co., Ltd., etc.