October 22，Drug Clinical Test Data On -site Check Plan No. 7。less than 7 months，No. 1 from March 30, 2016，By No. 7 on October 22, 2016，7 batches of inspection plan involved 185 acceptance numbers。

 

  The author will correspond to these 7 batches of 185 varieties corresponding to the first self -inspection variety (July 22, 2015 announcement，1622)、The second batch of self -inspection varieties (Announcement on April 1, 2016，181) and the third batch of self -inspection varieties (Announcement on September 1, 2016，82) In -depth analysis。

 

  In the past 3 months, the first batch of self -inspection no manufacturers will withdraw

 

  July 22, 2015，Announcement on the Verification of the Pharmaceutical Clinical Test Data Review of Drug Clinical Test Data "required the applicant，& ldquo; The first batch of clinical trial data authenticity、Integration、Self -checking。

 

  For the first batch of 1622 varieties of self -examination，Disposter 193 of clinical trials，There are 1429 varieties that need to be self -examination。According to & ldquo; The person in charge of the Pharmacization Registration Department of the State Administration of Food and Drug Administration, talk about the clinical data verification of new drugs & rdquo;，As of the end of June 2016，The company took the initiative to apply for the withdrawal of 1193，accounting for 83%of the total self -examination total。

 

  Compared with CFDA History stake sports betting appAnnouncement，Xianda Data v3.2 Discovery，317 registration applications actively withdrawn from Announcement No. 169, August 28, 2015; as of the recent announcement of the recent announcement, Announcement No. 45, March 1, 2016，Enterprise takes the initiative to withdraw the registration application for 876，Just 1193，Consistent with the withdrawal of the withdrawal at the end of June。This means that since the last self -examination withdrawal announcement, there has been no drug to take the initiative to withdraw。

 

  This means that the withdrawal of the enterprise has basically been finalized，So from March 30th, CFDA Food and Drug Audit and Inspection Center will conduct a site inspection plan for clinical trial data for drugs。

 

  On -site inspection does not approve rate or higher than 34%

 

  Pressing & ldquo; The person in charge of the Pharmacization Registration Department of the State Administration of Food and Drug Administration talks about the clinical data verification of new drugs & rdquo;，In fact, from October 2015，CFDA has carried out verification，but did not establish a system that announced the plan before the verification (the on -site verification plan was not announced before March 2016)。As of the end of September 2016，CFDA Check a total of 117 registration applications。

 

  CFDA made 30 decisions on the 30 of them before the end of September 2016，accounting for about 2%of the species of self -investigation and inspection; the 27 clinical trial institutions and contract research organizations (CROs) of 27 varieties suspected of data fraud are investigated。

 

  So，How high is the drug's non -approval rate after the drug clinical trial data of the CFDA Food and Drug Review and Inspection Center?

 

  In view of the announcement period of the 2016 Pharmaceutical Clinical Test Data Research Plan (No. 6), it is from September 14, 2016 to September 28, 2016，This means that the inspection at the end of September 2016 should be the variety of the first 5 on -site inspection plan，That is 81 acceptance numbers。

 

  Xianda Data v3.2 Discovery，The only pharmaceutical registration application announced in CFDA in 2016 will not be approved (2016 No. 92 & ldquo; the General Administration of the General Administration on the announcement of the 6 companies' 6 drug registration applications & rdquo;)，No acceptance number is from these 81 acceptance numbers，and stake sports betting appthe date announced this announcement is April 29，This indicates that all inspections that are not approved are completed before the first announcement of the drug and drug review and inspection center of the Food and Drug Review and Inspection Center (the date of release No. 2 on May 4)。

 

  In addition，7 announcements of the clinical trial data on the spot，Every time there are acceptance numbers from the first batch of self -examination，Currently involving a total of 138 first -rate self -check acceptance numbers，accounting for the first batch of self -examination 8.5%。This means that the first batch of self -examination clinical trial data on -site verification is still being carried out。

 

  The first batch of self -examination total 1622 acceptance number，Dispensing 193 of clinical trials，Removal of 1193 of the enterprise who took the initiative to apply for withdrawal after self -inspection，and deducting 10 acceptance numbers that are not approved by the registration application due to the failure to submit the self -inspection information and the unsuccessful withdrawal of the self -inspection information，Estimated 226 products are expected to face clinical verification。Among these 226 varieties，Remove 138 to enter the drug clinical trial data on -site inspection plan announcement the first batch of self -examination acceptance number，The remaining acceptance number is the maximum number of acceptance numbers for on -site verification before the system is announced by the on -site inspection plan。Divided the 30s that did not approve the number of acceptance numbers before receiving on -site verification before being established，It can be preliminarily estimated to be preliminarily estimated to be approved after CFDA on -site inspection，This ratio is not less than 34%。

 

  The second and third batch of self -inspection varieties have been launched on -site inspection

 

  At present, CFDA Food and Drug Review and Inspection Center has announced 7 batches of drug clinical trial data on -site inspection plans，A total of 185 acceptance numbers。

 

  2016，CFDA Announcement on April 1 and September 1, respectively, required clinical trial data self -examination of 181 & ldquo. & rdquo; Acceptance number。

 

  From the 4th drug clinical trial data on -site verification plan，All from the second batch of self -check acceptance numbers，Currently covering 29 acceptance numbers，accounted for 15.9%of the second batch of self -inspection acceptance Stake Sports Bettingnumbers。From the 6th drug clinical trial data on -site verification plan，There are also the third batch of self -check acceptance numbers，A total of 18 acceptance numbers，accounting for 22.0%of the second batch of self -inspection acceptance numbers。

 

  Table 1: Self -check batch acceptance number corresponding to the on -site inspection plan

 

 

  No. 1, No. 2 on -site check the directory existing products are approved

 

  Among the 185 acceptance numbers checked in 7 batches of on -site inspection，53%is the declaration variety of import manufacturers，However, no import manufacturer products are approved。

 

  The new medicines of Chinese medicine and biological products approved in September 2016 are all from the drug clinical trial data on -site inspection plan，On -site inspection plan announcement (No. 1) The proportion of registered batch number (new drug certificate) is 12.5%，On -site inspection plan announcement (No. 2) approval ratio is 15%。

 

  The earliest application year of 185 acceptance numbers can follow 2005，The declaration of 2006 and 2007 also has 1。Among them, the first batch of self -inspection lists in 2006 Chengdu St. Kang Pharmaceutical Co., Ltd. reported production in production data on the drug clinical trial data on -site inspection plan (No. 1)，and belongs to the list of drug approval number approved in September released by CFDA in 2016，Approved drug named Jiuwei Coptis Detoxification Ointment (National Medicine Quay Z20160002)。

 

  6 new medicines for Chinese medicine declared in 2006，After 10 years of clinical verification, it can be passed，This means that the long -term project is also possible to be approved。

 

  The same batch of self-examination lists and drug clinical trial data on-site inspection plan announcement (No. 1) of Xiamen Template Biological Engineering Co., Ltd. Quasi -word S20160001) also approved in September。

 

  Drug clinical trial data on -site inspection plan announcement (No. 2) The first batch of self -examination also received the acceptance number. It was also approved in September 2016，A rabies vaccine (Vero cell) for people from Dalian Yaolifeng Biopharmaceutical Co., Ltd.、Oral spinal ashcotitis reduction vaccine (durable cells) of the Institute of Medical Biology, Chinese Academy of Medical Sciences (S20160002) and Jiexiechang (Beijing) Pharmaceutical Co., Ltd. Quasi -word Z20160001)。

 

  Table 2: The product has been approved in the on -site inspection catalog

 

 

  Conclusion & gt; & gt; & gt;

 

  The newly approved pharmaceutical registration approval published by CFDA in the first three quarters of 2016 is mainly chemical drugs and injections，Most stake online sports bettingof the oral oral drugs have not yet started approval。

 

  Generally speaking，Factors who can wait for the on -site verification of CFDA without withdrawal are usually confident in their own projects，It is a project with good market and project quality。

 

  September Chinese medicine and biological products new medicines are approved，It means that the conclusion of the on -site verification of the clinical trial data of the drug will be gradually disclosed，and a lot of good products are expected to be approved。