In a blink, it comes to the end of another year! 2017 is being further away. Do you know what are the new Chinese-produced drugs approved for production in this year, as a pharmaceutical practitioner?
Chinese-produced new chemical drugs with 16 acceptance numbers approved for production
Looking back the drug registration application situation of China in 2017, chemical drugs still dominate the drug registration application field in China. According to statistics, by December 21, the quantity of acceptance numbers of chemical drugs undertaken by CDA was 3,696 in total and there were 191 acceptance numbers of chemical drugs approved for production.
CFDA introduced the reform plan for chemical drug registration classification in March 2016. The new measures for administration are stricter with the definition of new drugs, compared to the previous measures for administration of classified applications of pharmaceutical product registration in 2007. According to the new measures for administration of registration, "For the pharmaceutical products under Class 1 and 2 of new registration classification, application shall be submitted in accordance with the procedure for new drugs in the Measures for the Administration of Drug Registration; for the pharmaceutical products under Class 3 and 4 of new registration classification, application shall be submitted in accordance with the procedure for generic drugs in the Measures for the Administration of Drug Registration."
According to statistics, after issuance of the new edition of the Measures for the Administration of Drug Registration, there were 272 acceptance numbers of Class 1 new chemical drugs approved for clinical trial by December 21, 2017, and there is no Class 1 new chemical drug approved for production for now. The article Another Good News! Outburst of HEC Pharm: Approved for Clinical Trials of 4 Class 1 New Chemical Drug Varieties of the official account of CPhI can be referred to for relevant information.
However, according to the measures for administration of classified applications of pharmaceutical product registration in 2007, among the Chinese-produced new chemical drugs applied for previously, there were 16 acceptance numbers of drugs approved for production in 2017, covering 7 APIs, and including 1 registration application of Class 3.4 new drug, and 15 registration applications of Class 3.1 new drugs. See the following table for the details.










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