Data perspective of 289 consistency evaluation varieties
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Last Update: 2016-06-03
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Source: Internet
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Author: User
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Statistics of national basic medicine catalogue chemical medicine volume 2012 edition national basic medicine catalogue, chemical medicine part Tripterygium polyglycoside tablets, belladonna tablets: not included, according to the management of traditional Chinese medicine, the basic medicine is classified as Chemical Medicine Compound Glycyrrhiza tablets: according to the management of chemical medicine, this list does not include the drug number It is said that the first batch of 289 drugs is not 292 drugs The name of the first batch of 289 drugs is not the same The name of the first batch of 289 drugs lies in the following: oral rehydration salt = oral rehydration salt powder, tamoxin hydrochloride sustained-release capsule = tamsulosin hydrochloride sustained-release capsule, prednisone acetate tablet = prednisone acetate tablet How many basic drug varieties are left? List of the second batch of oral solid evaluation? Sorry, I don't seem to have any! In addition to the two varieties, all the basic drugs oral solid has been included completely, only the dimensions of injection, oral liquid and external varieties are left: the most neglected varieties? Note: in addition to the above two drugs, the 289 list covers all chemical based oral solid preparations (all drug specifications) Berberine hydrochloride tablets: the 292 list is 30mg (not available), 289 is changed to 50mg, 100mg Aspirin enteric coated tablets: the original reference specification was 100mg, which was excluded from the list Question: are the remaining specifications available after October 1, 2007? Answer: aspirin enteric coated tablets and berberine hydrochloride tablets both have one basic drug number as the enterprise dimension after the new regulation: where are cro customers? Note: the cost of consistency evaluation is roughly calculated by 5 million yuan per document number What about the document number of traditional Chinese medicine? Is it possible to exist alone? Original research reference delisting contention: does the original 5 categories of new drugs need consistency evaluation? Note: the above varieties are all 289 list varieties, which have been included in the consistency evaluation list The original research reference specification is not included in the 289 list - reason 1: rejected by the base drug Note: foreigners are more resistant to manufacturing, and large specifications are mostly excluded by the base drug catalog (the above table is only an example) The list of basic drugs also includes the large specifications of individual varieties - reason 2: basic drugs are included, but they are excluded by 289 Note: what can't be done is forced, what can't be done is not allowed? It is not important whether it is included or not It is the same as the first three varieties! Consistency evaluation object and implementation stage (I) generic drugs approved for listing before the implementation of new registration and classification of chemical drugs, including domestic generic drugs, imported generic drugs and local varieties of original research drugs, must carry out consistency evaluation (2) For the chemical generic oral solid preparations (attachments) approved for marketing before October 1, 2007 and listed in the national basic drug catalog (2012 version), in principle, the consistency evaluation shall be completed by the end of 2018 (3) the chemical generic oral solid preparations other than the above (2), and the enterprise can organize the consistency evaluation by itself; since the first After the varieties pass the conformity evaluation, the application for conformity evaluation of the same varieties of other pharmaceutical manufacturers will not be accepted after three years
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