Comments on CFDA drug approval in February 2016

According to statistics, in February 2016, CFDA approved a total of 38 new domestic approvals Among them, there are 31 chemical approval documents, 7 traditional Chinese medicine approval documents, and no new approval documents for biological products According to the statistics of removing and replacing approval documents, there are 15 new domestic approval documents for chemical drugs and no new domestic approval documents for traditional Chinese medicine Among the 15 new approvals, only one new drug belongs to category 3.1 according to the classification of drug registration, and the rest are all category 6 According to the dosage form, 7 are APIs and 6 are injections Nadroparine calcium API of Tianjin Biochemical Pharmaceutical Co., Ltd belongs to class 3 new drugs Among the raw materials of nadroparin calcium, Tianjin Biochemical Pharmaceutical Co., Ltd is the second approved manufacturer (the first is Yantai Dongcheng Pharmaceutical Co., Ltd., which was approved in 2015) Nadroparin calcium injection of Tianjin biochemical pharmaceutical was also approved At the same time, the production approval of carbetoxine API and injection of Shenzhen Hanyu Pharmaceutical Co., Ltd This is the second manufacturer to obtain both API and injection approval after Chengdu shengnuo bio Pharmaceutical Co., Ltd in January 2016 Shanghai Tianwei biopharmaceutical Co., Ltd has been approved to use urofollicle stimulating hormone for injection The product is used for those who do not ovulate (including polycystic ovary syndrome) and have no effect on clomiphene citrate treatment, as well as those who are used for superovulation by assisted reproductive technology In the past, only Lizhu pharmaceutical obtained the domestic production approval Now, Tianwei biopharmaceutical is the second enterprise to obtain the production approval, which may affect the market pattern of the variety For other varieties, due to the existence of a large number of old approvals, it is estimated that the new approvals have little impact on the market For example, the number of Ambroxol Hydrochloride Injection approvals has reached 32, and the number of Oxymetazoline Hydrochloride Spray approvals has 9 In terms of import approval, in February 2016, there was only one new approval, that is, epicycline hydrochloride API of Mercian company.