August 11，The State Food and Drug Administration issued the "Announcement on Carrying out the Checking of Drug Production Technology" (draft for comments)，Requires drug manufacturers to carry out self -examination of the production process (traditional Chinese medicine system) that approved the listing of drugs for listing drugs，Remove the hidden dangers of quality and safety。

 

   According to the announcement requirements，The actual production process of self -checking is the actual production process stake sports betting appof drugs and the production process approved by the food and drug supervision department。Drugs should complete self -examination and report to self -checking situation before October 1, 2016。

 

  According to the self -examination results of the pharmaceutical company，The following treatment measures should be taken respectively:

 

  1. The actual production process is consistent with the approval production process

 

  Pharmaceutical manufacturers should file the self -examination report with the drug production process and other information.，Daily supervision as a regulatory authority、Preparation information for on -site inspection。

 

  2. The actual production process is inconsistent with the approval production process

 

  Requires full research and verification.

 

  The change in production process changes on the quality of the medicine，Drug production enterprises shall apply for supplementary applications in accordance with the "Administrative Measures for Drug Registration"。

 

  The influence of changes in the production process will affect the quality of the drug，Enterprises should discontinue production immediately。

 

  Drug production enterprises shall complete the research and verification of product species production technology before June 30, 2017、Submit related work such as supplementary applications，Other non -production species should be completed before December 31, 2017; if it is not completed on time,，Should stop production。

 

  Self -checking, Flying Inspection both princes, stake online sports bettingor welcoming a large number of pharmaceutical companies to discontinue production

 

  According to the announcement requirements，From November 1, 2016，CFDA will organize experts to conduct flight inspections on pharmaceutical manufacturers。During the inspection, it was found that the actual production process is inconsistent with the production process approved by the food and drug regulatory authorities，According to relevant regulations，The medicines produced by the fake medicine theory。

 

  Some people in the industry said，Check the production process，implies that the bottom -up salary of the pharmaceutical industry is about to start。

 

  As early as 2007，The State Drug Administration Department has already proposed that the special concentration operation of the drug production link will focus on the production process inspection，Supervisor drug manufacturers produced in accordance with the approval process，Never allow any excuses，Change the production process and prescription without authorization。

 

  but，Why are there so many pharmaceutical companies to change the production technology without risk? In the ginkgo leaves of 2015，Guilin Xingda Pharmaceutical was found in a flying inspection that there was an illegal behavior such as changing the extraction process without authorization，and the pharmaceutical company also paid a heavy price for its own illegal acts，Eventually under administrative punishment，stake betting appand revoke the company's drug production license。

 

  Some people in the industry said，When the pharmaceutical company originally applied for a drug，Its process and process is reported by the data of the laboratory。In actual investment in production，Due to changes in the environment and equipment，The stability of the drug may be a problem，At this time, pharmaceutical companies have to adjust the process，to obtain relatively correct data to deal with the flight inspection and other various inspections。

 

  Soft in the new version of GMP、Hardware requirements and strict flight inspection，For pharmaceutical companies，There is another death factor that is the profit。Many small and medium -sized pharmaceutical companies operate regularly，There is no competitiveness in the face of profit。So，There is simplified production process、Tampered with non -compliance behaviors such as production technology。

 

  Now，The State Food and Drug Administration passed the enterprise self -inspection and flight inspection，Orientation cracking production process problems，There must be many pharmaceutical companies exposed the problem in the strict flight inspection，At that time，Or it will usher in the tide of suspension of production in a large number of pharmaceutical companies。