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CFDA on -site inspections will once again attack transnational pharmaceutical companies or will hit the gun
Release time: 2016-07-13 & nbsp & nbsp & nbsp Source: Anonymous
  & ldquo; CFDA checks 100%of the data, regardless of the nature of the problem, punish & lsquo;,No one can be spared,Even foreign companies will have problems。& rdquo; It is reported,Since the 722 storm of 2015,In 1622 varieties, nearly 80%of the varieties have chosen to take the initiative to withdraw and accept & ldquo; fate for not approving & rdquo;stake sports betting app,Stake Sports BettingAbout 300 medicines remaining in the re -baptism of clinical trial data on -site verification。CFDA On -site Inspection No. 4 announced,What will the multinational pharmaceutical companies have in this round of verification?
 
  March 30,Food and Drug Review and Inspection Center of the State Drug Administration (CFDA) issued the "Announcement of Planning Data Reporting Plan (No. 1)",Plan to conduct on -site verification of 16 drug clinical trial data such as Foga Naidin tablets。This is the first batch of clinical verification drugs released by CFDA。
 
  July 8,CFDA announced the fourth announcement of the on -site inspection stage,It is also the most variety involved to date。Different from the previous three times is,In the announcement of the fourth batch of clinical trial data on -site inspection plans,Related varieties of multinational pharmaceutical companies account for 24 of all 32 varieties,is the absolute & ldquo;。
 
  According to the "Notice of Temporary Test Procedures (Interim)" issued by CFDA in March,The inspection team shall conduct on -site inspections in accordance with the content of the "Points for Data on the Data Clinical Test Data"; the inspection record should be specific、Accurate、My stake betting appQuantitative,stake betting appIt affects the safety of drugs、Effective evaluation data for authenticity、Complete judgment,It should be obtained according to law。
 
  What is the result of multinational pharmaceutical companies in this round of verification? CFDA has publicly stated: & ldquo; After making a decision to make approval,Announcement on the relevant situation of the drug registration application found out of the on -site verification of the problem and not approved。Survey investigation of suspected fraud。& rdquo; Who will hit the gun?
 
  Previous,A local pharmaceutical company that had undergone on -site inspections revealed to reporters: & ldquo; CFDA's 100%verification of data, regardless of the nature of the problem & lsquo;,No one can be spared,Even foreign companies will have problems。& rdquo; Although the on -site verification points have been announced,But the specific implementation scale of foreign companies has received widespread attention。
 
  Earlier,There were rumors in the industry,Foreign companies have prepared relevant legal preparations for the legality disputes of the inspection method and the results of the judgment.。According to a person familiar with the matter,Discussions of foreign companies and stake online sports bettingCFDAs Stake Sports Bettinghave been communicating in communication with CFDA to verify the execution strength and scale。Discovery,The results of the previous three batches of on -site verification should be announced recently。From the current communication situation,The foreign company involved in the published inspection list is more optimistic about the prospects of on -site verification。
 
  The result of the on -site verification results of the foreign company variety is about two reasons: one is two: one is,If most of the foreign companies pass through,It means that the scale of CFDA's judgment in the on -site inspection has changed,In addition to fraud,The incomplete existence in the data、Is the problem of irregularity as a variety of & ldquo; immediately shot & rdquo;,Depending on the specific impact of the data involved on the entire clinical trial, it depends。This seems to be what most companies expect to see。Two is,The companies that have been withdrawn or have been checked on the spot are all watching the foreign companies' & ldquo;,This not only tests the scientific nature of CFDA for on -site inspections、Fairness,Also & ldquo; Rebuilding the good ecological environment of drug research and development,Fundamentally promoting stake online sports bettingthe stake betting apphealthy development of the pharmaceutical industry & rdquo; how to create the key to create。