May 31，The State Food and Drug Administration released the "2016 Drug Inspection Report"，Report display，In 2016、Drug GMP certification check、Drug GMP tracking check、Flight checkup、Imported drugs overseas production site inspection、Circulation inspection and observation inspection 434 items; and plan to check 466 pharmaceutical companies in 2017。

 

  ▍ Flying test is the largest, the most traditional Chinese medicine problems

 

  Report to point out，In 2016, the General Administration of the General Administration completed a total of 39 flight inspections of pharmaceutical manufacturers，Including 9 biochemical drug manufacturers、20 Chinese medicine manufacturers、9 ordinary chemical drug manufacturers and 1 blood product manufacturer，Among stake sports betting appthem, stake online sports betting14 companies have been recovered by the pharmaceutical GMP certificate，10 companies have been filed for investigation，7 companies' problems products are ordered to recall。

 

  Director Ding Jianhua, Director of the Director of the Division of the General Administration of Food and Drug Administration, introduced at the press conference held on the same day，Flight examination is a highlight of the 2016 drug examination。

 

  He said，After discovering the risk of drugs in the past，Often is & ldquo; after the fire, go to the fire & rdquo;，Damage is likely to cause。In recent years，We carried out a targeted pharmaceutical examination through flight inspection，The problem of finding the problem is very high，This caught a negative typical，Education、Warning a group of companies，Make similar drug risks no longer expand。

 

  In 2016, the General Administration of General Administration was deployed in the circulation link to carry out illegal business behavior centralized rectification.，38 companies that have discovered illegal and illegal acts were issued to be exposed，and ask the Provincial Bureau to severely investigate and deal with it。

 

  In the flight inspection of drug production enterprises，More problems found in Chinese medicine and biochemical drugs。Existing Chinese patent medicine manufacturers change craftsmanship and Chinese medicinal materials without authorization、Traditional My stake betting appChinese medicine drinking Material Management Chaos，Some artificial beefly enterprises cannot organize production and supplier management links in accordance with the requirements stake sports betting appof drug GMP，Chinese medicine drinking tablets dyeing、weight gain and other problems。The General Administration has dealt with the problems found in the flight inspection in accordance with laws and regulations。

 

  Not only that，In 2016, the General Administration also focused on 10 companies that were unqualified for the 2015 quality announcement、36 (38 in the country) vaccine manufacturers、25 (26 in the country) blood product manufacturers、32 companies issued a letter of warning in 2015 conducted tracking inspections， and 67 high -risk varieties (such as osteopptide injection、Sodium sodium phosphate injection、Sodium injection of phosphorus choline injection, etc.) for special examination。

 

  Completed a total of 204 follow -up inspections in the whole year，increased by about 13%year -on -year compared to 2015。There are 12 companies that are not approved，There are 58 companies that have warned the letter。Among the 12 companies that are not approved，There are 5 companies with unqualified annual drawings in 2015，2，1 骨 peptide injection production enterprise 1。The results of the test results of the vaccine and blood production enterprises are all passed。

 

  ▍ Imported drugs overseas examination，The raw medicine is the most international inspection

 

  2016 overseas tasks involved 19 countries，Not only covering developed countries and involving developing countries，At the same time, the inspection strength of South America and the Oceania。

 

  Completed a total of 15 varieties inspection tasks in 2016，3 varieties cannot pass，The non -pass rate has increased compared with previous years。Check a total of 117 items found in a total of 117 items，My stake betting appStake Sports BettingAmong them, 3 items of severe defects，main defects 18 items。The problem is mainly concentrated in quality control and quality assurance、Material System、Change management, etc.; serious defects are mainly issues such as production process consistency and data reliability。The problems found overseas inspections are processed according to law and regulations。

 

  In 2016, it also completed 81 observations of drug GMP inspections carried out by foreign regulatory agencies or international organizations in my country，76 companies involved，Among them, 62 inspections involved in raw medicines，About 69%of the total number of inspections，The proportion of raw materials is still the largest。Observation and inspection involves 12 international organizations or foreign regulatory agencies including the World Health Organization (WHO)。Among them, 9 companies were inspected and found serious defects，Data reliability issues are more prominent。

 

  ▍ 2017 Inspection Plan 466 pharmaceutical companies

 

  2017 National Drug Inspection Plan to check 466 pharmaceutical manufacturers，Including tracking and inspecting 316 manufacturers、& ldquo; Double random & rdquo; Check 150 manufacturers。

 

  Checking the focus is the vaccine and blood product manufacturers、Discovery of unqualified varieties in the previous year、Production enterprises of severe adverse events or early warning events found in the adverse reaction monitoring，Enterprises that are not approved or issued by all kinds of inspections、Production enterprises with a concentrated variety and risk signals，and some traditional Chinese My stake betting appstake sports betting appmedicine drinks that are layered dual -randomly extracted for different risk levels and variety characteristics，Biochemical drugs，Production enterprises using Chinese medicine extracts, etc.。At the same time, it will continue to surround drug production、Circulation links carry out flight inspections。