Three years of pharmaceutical reform, five major changes, affecting all pharmaceutical companies
Source:赛柏蓝
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Author:赛柏蓝
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Published time: 2018-08-20
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By the end of 2017, 19 supporting documents had been issued. By August 17, 2018, the acceptance number of consistency evaluation undertaken by CDE had reached 311, with a total of 139 varieties. Among them, there are 136 varieties in 289 catalog, totaling 52 varieties. There are 60 injectable acceptance Numbers and a total of 30 varieties. A few days ago, I have published the following article specifically, here no longer elaborate.
The data should be "true"
Due to historical reasons, clinical trial data authenticity exist serious problem, it is the leading cause of the past research and development of Chinese medicine quality is not high, the main reasons for the July 22, 2015, the original CFDA issued "about a drug clinical trial data comprehensive inspections of announcement (commonly known as" industry "the 722 massacre") for 1622 clinical trials after checking and verification of 203 varieties, 463 registered clinical trial institution to carry out the on-site inspection, on suspicion of fraud data of 27 varieties, 11 clinical trial institution and contract research organization (CRO) to initiate an investigation, Enterprises voluntarily withdrew and verified 1,323 registration applications that were not approved. A series of measures have completely changed the poor situation of clinical trials in China.
