A large wave of new drugs of category 3.1 were withdrawn from the trial

Recently, Ding Xiangyuan's insight database and medicine magic square website show that: since July 23, the status of some clinical applications for class 3.1 new drugs has become "approved - to be certified" What does this mean? How many varieties are involved? How much will follow? According to industry analysis: this directly refers to the relevant class 3.1 new drugs to be approved have been returned to the central examination At present, the database shows that there are two varieties involved However, it is estimated that more 3.1 new drugs will be added to this camp in the future In a more popular way, let's feel the visual sense of class 3.1 new drugs being shot by a centralized machine gun This is a big move for CDE to clear up the backlog of new drugs to be reviewed after the clinical trial self inspection and No 140 document In recent years, the application of class 3.1 new drugs with a great fever has been forced to cool down physically Look at the current approval status of related varieties: centralized review? Centralized review! At present, the two varieties with centralized changes are acitinib and abitrone: Pfizer's atitinib for the treatment of advanced renal cell carcinoma (RCC), which was approved for listing in China in April 2015 Before the approval, seven enterprises have applied for class 3.1 acitinib Similarly, Xi'an YANGSEN's abitrone, which is used to treat prostate cancer, was just approved for listing by CFDA in May 2015, compared with 27 enterprises that have declared the class 3.1 abitrone Of course, there are voices that: do these new drugs enjoy the treatment of "centralized evaluation of the same varieties in the backlog" in document 140? NO! Industry insiders like to show you how your new drug evaluation is Firstly, the drug audit center of Lanzhou was used to accept the acitinib of soupfizer, a variety search expert Its review status is that the review status is completed - the approved document is Chen * 010-8 * * * 7, and any other query will find that the review status is completed - to be prepared What does this difference mean? Bare approval completed - to be verified, is the letter of withdrawal And if you don't have the time to start the review in your home's specific information, only the time to end the review, this abnormal situation suggests that the drug may be directly withdrawn from the review Only when you see that the voucher preparation with contact person and contact number has been completed - the approved document has been issued, it should be approved Others, including the voucher preparation with province and a series of numbers - the approved document has been issued, and the approval completed without anything - to be prepared, are all rejection letters This time, a large number of 3.1 types of acitini and abitrone were changed, and it was confirmed that they were withdrawn from the trial in a centralized way Form: application acceptance from the end of July to the beginning of August