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The announcement shows that 7 drugs through the audit meet the requirements of the network, 24 drugs due to over-evaluation greater than 3 canceled the network qualification, the specific catalog is as follows: "Shanxi Province to implement the national organization of centralized procurement and use of drug pilot expansion of regional scope work programme" explicitly mentioned that the inclusion of the pilot expansion of 25 generic drugs, the same varieties of drugs through consistency evaluation of the production enterprises reached more than 3, in the case of ensuring the supply of drugs no longer in line with the selection of non-conformity.
before, on November 26, 2019, Shaanxi Province Drug Collection Procurement Network issued "on the national organization of centralized procurement and use of drugs to expand the regional scope of the notice", the notice mentioned: the same generic dosage form with the same specifications have been linked to the network through consistency evaluation products reached more than three, the cancellation of the unrated products of the network qualification.
19 drugs were removed from the notice, plus 24 drugs in this announcement, a total of 43 drugs in Shaanxi were disqualified from hanging online, and the hospital market is not related.
a batch of drugs cancelled according to March 5, 2016, the General Office of the State Council issued the "On the implementation of generic drug quality and efficacy consistency evaluation of the opinions (State Office issued (2016) No. 8)," clearly requires that the same varieties of drugs through the consistency evaluation of the production enterprises to reach more than 3, in the centralized procurement of drugs and other aspects of the selection of non-conformity evaluation of the varieties.
this means that once this variety consistency evaluation has been full of three pharmaceutical companies, the variety has not been consistent evaluation, will face the loss of the hospital market.
, according to the requirements of the State Drug Administration, generic drugs containing basic drug varieties approved for listing prior to the implementation of the new registration classification of chemical drugs, since the first variety has passed the consistency evaluation, other pharmaceutical manufacturers of the same varieties in principle should complete the consistency evaluation within 3 years.
with more and more varieties through consistency evaluation, the first three-year period after evaluation, for many pharmaceutical companies, is the pressure, but also the driving force for continuous progress.
otherwise, otherwise, it is not only the hospital market that is lost, it is likely that even the drug approval will not be insured.
with the introduction of generic drug consistency evaluation policy and documents, the promotion of national volume procurement, many pharmaceutical companies have realized that generic drug consistency evaluation is the general trend.
not only to do, but also to do it early.
otherwise, products will soon lose their competitiveness to enter the market.
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