echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > Consistency evaluation is on the way: non 289 catalog 30 products are expected to get logo

    Consistency evaluation is on the way: non 289 catalog 30 products are expected to get logo

    • Last Update: 2017-09-07
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Source: medical economic news 2017-09-07 Medical network, September 7, 2017 CFDA / CDE has issued several consecutive announcements (as shown in Table 1) on the consistency evaluation, including the announcement of the current progress of generic drugs in the 289 directory and the "pass the consistency evaluation" logo The prototype of China's generic orange peel book (China's list of listed drugs) has also issued a draft for comments, which means consistency The evaluation began to enter the policy implementation period Table 1: list of policies issued by CFDA / CDE in the near future (data source: Xianda data v3.2) 289 catalog varieties: reference preparations are not fully prepared According to the announcement of the General Administration on the issues related to the consistency evaluation of the quality and efficacy of generic drugs, in order to facilitate enterprises to select reference preparations, CFDA General Administration will list 289 varieties of original research enterprise drugs attached to the announcement on the implementation of relevant issues (No 106, 2016) and publish them to the society for reference when enterprises select reference preparations According to Xianda data v3.2, after sorting out the eight batches of reference preparations published by CFDA as of September 6, 2017, it is found that there are still 112 reference preparations not published in 289 catalog products In addition, CFDA promises that all the reference preparations submitted by the enterprise to the State Administration for filing will be open to the public In contrast, enterprises are still relatively active in applying for reference preparations According to the data display of enterprise reference preparation filing (from May 20, 2016 to August 20, 2017) released by CFDA on September 4, 2017, 46 products in 289 catalog have not been filed for reference preparation filing There are 23 products of reference preparation that have not been published by enterprises and countries However, compared with the basic situation that CFDA published that enterprises carried out the consistency evaluation of quality and efficacy of generic drugs in 289 catalog, it was found that only five products did not carry out the consistency evaluation, and other products were carried out by enterprises This means that the information of the consistency evaluation between the reference preparation filed by the enterprise and the actual implementation is still poor Table 2: there is no list of reference preparations in enterprises and countries (data source: Xianda data v3.2) Varieties other than 289: 30 drugs have been identified as "consistent" Since June 2017, the office of quality and efficacy consistency evaluation of generic drugs has published two batches of product review and inspection institutions other than 289, including 30 products The author believes that the 30 products should have the conformity assessment declared by the enterprise, and the conformity assessment office of quality and efficacy of generic drugs will announce the review and inspection institution As shown in Table 3, lupatadine fumarate tablets, tramadol hydrochloride tablets, cephalosporin tablets, losartan potassium tablets, Mecobalamin tablets, oxcarbazepine tablets, torasemide tablets, isoretinoic acid soft capsules, Avastin capsules, pasianzide tablets, Avia capsules, donepezil hydrochloride tablets, orlistat capsules and meloxicam tablets have not been applied for clinical application since 2017 Among them, tramadol hydrochloride tablets and donepezil hydrochloride tablets of Petrochemicals Group, losartan potassium tablets of Huahai Pharmaceutical Co., Ltd., and meloxicam tablets of China Resources Shuanghe all obtained anda of the United States Besides donepezil hydrochloride tablets, they are all domestic listed products It is estimated that the 14 products that have not started clinical practice since 2016, but have entered the review list, are the products that are produced jointly in China and listed in Europe, America and Japan Among the 16 clinical products launched after 2016, Yangzijiang Pharmaceutical Group Co., Ltd has the largest number of exclusive clinical products, three of which are anastrozole tablets, finasteride tablets and eparata tablets In terms of products, rosuvastatin calcium tablets have the highest heat of clinical initiation Table 3: clinical application of varieties other than 289 catalogue of recheck and inspection institutions from 2016 to now (data source: Xianda data v3.2) thinking about the main policy advantages of consistency evaluation at present: when centralized purchase of drugs means purchase by medical institutions, manufacturers enjoy the right of price preference However, at present, the office of quality and efficacy consistency evaluation of generic drugs has not released the list of varieties that have passed the consistency evaluation This also means that 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 drugs that have not passed the consistency evaluation in terms of centralized purchase of drugs, etc "and" for the drugs that have passed the consistency evaluation, the social security department will give appropriate support in the aspect of medical insurance payment, and the medical institutions should give priority to purchase and choose the drugs in clinical practice " Not implemented It is worth noting that due to the "zero plus" reform of medical institutions, hospitals began to host pharmacies, and the market of oral drugs gradually shifted from medical institutions to out of hospital pharmacies However, pharmacies are not subject to the policy of centralized drug purchase, which means that they can still sell the varieties that fail the consistency evaluation Therefore, from the current point of view, the policy benefits of the varieties through the consistency evaluation are limited, which can only be expected to be used by medical institutions in the context of medical insurance payment.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.