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    Home > Active Ingredient News > Drugs Articles > 14 consistency evaluation drugs in Hunan Province lose the qualification of network

    14 consistency evaluation drugs in Hunan Province lose the qualification of network

    • Last Update: 2018-12-22
    • Source: Internet
    • Author: User
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    [China Pharmaceutical network industry trends] on December 20, Hunan Public Resources Trading Center issued the notice on publicizing the results of verification of application materials for new drugs and conformity assessment drugs (hereinafter referred to as the notice) According to the detailed list of inspection results of new drugs issued in the notice and application materials of generic drugs for conformity evaluation of quality and efficacy, 73 drugs failed to pass the inspection because of their unqualified qualification, including 14 drugs produced by different enterprises that had passed the conformity evaluation, and failed to pass the inspection because they did not meet the relevant regulations   It is understood that previously, the notice on ensuring the supply of varieties for consistency evaluation of quality and efficacy of new drugs and generic drugs issued by China has stipulated that the varieties passing the consistency evaluation and compliance with the regulations are deemed as the ones passing the consistency evaluation, and the manufacturers are allowed to directly use the average Provincial Price (excluding the provinces adopting the market price mode temporarily) of the three low provinces after the consistency evaluation Hook up network for medical institutions to purchase The price collection range for price linkage of such products is the price after consistency evaluation For varieties without provincial price, the reasonable price can be determined temporarily For those with provincial price less than three, the price will be adjusted to the low provincial price temporarily, and the price will be reduced in time within 30 working days after the emergence of new provincial price If the product is not lowered in time as required, the online sales qualification of the product shall be cancelled The products that have been included in the scope of online purchase of medical institutions through consistency evaluation can continue to be supplied at the original price or directly online If there are more than three manufacturers of the same kind of drugs that have passed the consistency evaluation, the varieties that have not passed the consistency evaluation will no longer be included in the procurement scope of medical institutions Through the consistency evaluation, varieties can be applied for the identification "through the consistency evaluation" in the provincial medicine centralized procurement platform Medical institutions should give priority to the procurement and use of varieties that have passed the consistency evaluation From the above regulations, it can be inferred that the consistency evaluation drugs produced by these 14 different enterprises in Hunan Province may not meet the relevant regulations due to the failure of timely price reduction, and will also lose the qualification of online sales At present, in order to stabilize the product market, some domestic pharmaceutical enterprises have taken the initiative to reduce the price of some drugs, and we can also see the information about the price reduction of some online drugs on the drug purchase platforms of various regions As far as I know, the situation that the purchase of consistency varieties is suspended because the price cannot be lowered also occurs in many places For example, on October 26 this year, Hubei provincial public hospital drug (consumables) supply security comprehensive management network issued the notice on adjusting the information of online listing of failed conformity evaluation varieties, which showed that 5 failed conformity evaluation varieties were suspended from online listing, involving 14 drugs from 10 production enterprises In view of the reasons why these 14 drugs were suspended from the Internet, five of them were because the enterprises did not pass the consistency evaluation did not accept the price reduction According to the notice issued by Hunan Province, the publicity period is December 19-25, 2018 If there is no objection, after the end of the publicity period, the products meeting the requirements of the notice shall be included in the provincial online drug catalog, marked as "new drug" or "drug through consistency evaluation", and the new online price shall be implemented If you have any objection, please submit the paper materials with official seal to Hunan public resources trading center before 17:00 on December 25.
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