Medical net July 3 general administration warning: clinical trial data have a problem, voluntarily withdraw is ok, check to punish severely! The 106 companies took the initiative to withdraw 135 of them.
▍ 135 for drug registration, take the initiative to withdraw
On June 30, the state administration of food and drug administration issued a notice for 106 companies to withdraw 135 drug registration applications (no. 80 of 2017). The application for the withdrawal of the drug is announced in the "self-check notice".
Administration said in the release of the implementation of drug clinical trial data check list for verification of announcement no. 117 (2015) and "about drug clinical trial data check list check the announcement of registration of 2016 (no. 81, no. 142, no. 171, no. 202 and no. 42, no. 59, 2017), for drug registration applicant to report has the manufacture or import pending drug registration application for drug clinical trial data check list for verification.
After self-examination by the applicant, 106 enterprises have voluntarily retracted 135 drug registration applications (see appendix).
▍ 106 companies, Chinese and foreign companies
In the list, Chinese and foreign famous enterprises cluster.
The collective emergence of foreign giants such as moxandong, novartis, shi guibao and sumitomo; Domestic pharmaceutical companies such as tong ren tang are also listed.
Since the new drug is always a big business, looking at it from another perspective can at least show that the company is a step forward in research and development.
For clinical data verification, the general administration has been paying more attention. In all previous announcements, and emphasized: drug registration applicant inspection found that drug clinical trial data authenticity problems, should take the initiative to withdraw the application for registration, the administration announced its list, shall be investigated for their responsibility.
If not, discover false, will be treated with heavy. And to investigate the responsibility of inspectors of the food and drug administration who failed to perform their duties effectively.
▍ withdraw, data may be false, also may be the companies strive to perfect
Are there any questions about the authenticity of the data in the 135 applications that are withdrawn? To that end, cypress blue has been informed by experts in this field, not quite.
Part of the problem is the data, and part of it is the company's caution under the administration's verification of high pressure.
All is not as the senior personage says "data fraud. Under the magic and the abyss of death trial, some companies decided to withdraw, strive for perfection, strive for one-time pass, this is logical." |
