Medical network on June 1 - May 31, the state food and drug supervision and administration bureau released the drug inspection report "for 2016, according to the report, to carry out the drug registration in administration, 2016 production site inspection, drug GMP certification examination, drug GMP tracking check, flight check, imported drugs outside production site inspection, circulation and observation to check 434; It plans to look up 466 drugs in 2017. 

 

Most problematic ▍ fly biggest, traditional Chinese medicine 

 

According to the report, complete the pharmaceutical production enterprise in administration, 2016 flight check 39 times, including 9 biochemical pharmaceutical production enterprises, 20 Chinese medicine production enterprises, nine common chemical production enterprises and 1 blood products production enterprises, including 14 companies recalled drugs GMP certificate, investigation of 10 enterprises, seven problems of the products were ordered to recall. 

 

The flight tests were a highlight of the 2016 drug inspection, said ding jianhua, director of the administration of pharmaceutical supervision and administration of food and drug administration, at a press conference that day. 

 

In the past, he said, the risk of drugs was often "after the fire" and the damage was likely to have been done. In recent years, we have targeted to carry out by means of flight check drug inspection, found the problem rate is very high, so seized an opposite model, education, warning a batch of enterprises, makes a similar drug risk no longer expanded. 

 

Administration of 2016 deployed in circulation to carry out illegal conduct centralized regulation has sent 20 flight inspection group of 30 provinces 50 flight inspections on pharmaceutical wholesale enterprises, to found a 38 companies issued a notice of violation behavior exposure, and requires ShengJu is investigated. 

 

In the inspection of drug production enterprises, there are more problems with traditional Chinese medicine and biochemical drugs. Existing proprietary Chinese medicine production enterprises unauthorised changes to the process and traditional Chinese medicine, Chinese medicine yinpian material management chaos, some artificial bezoar enterprises can't organize production according to requirements of the pharmaceutical GMP and weak supplier management, Chinese medicine yinpian dyeing, weight gain and other issues. The general administration has already handled the problems found in flight inspections in accordance with the law. 

 

Administration of 2016 is also focusing on 2015 quality announcement selectiving examination unqualified 10 enterprises, 36 (38) during the national vaccine production enterprises, 25 (26) during the national blood products production enterprises, 2015 warning signals in 32 enterprises to carry on the track inspection, and varieties of 67 higher risk (such as bone peptide injection, fructose ErLinSuanNa injection, citicoline sodium injection, etc.) conducted a special inspection. 

 

There were 204 annual follow-up visits, up about 13 percent from the same period in 2015. There are 12 companies that do not pass, and there are 58 companies that advise. Of the 12 companies that did not pass the inspection, there were five companies in the year of 2015, and two in the production enterprise of cytophosphoroline sodium injection, and one in the production enterprise of osteopepine injection. The vaccine and the blood production enterprise were all approved. 

 

▍ imported drugs overseas examination, API is most international inspection 

 

The 2016 foreign missions cover 19 countries, covering both developed and developing countries, while increasing inspections of South America and Oceania. 

 

In 2016, there were 15 different kinds of inspection tasks, and 3 varieties did not pass, and the rate of passing was higher than in previous years. The defects were found in 117 defects, including 3 major defects and 18 main defects. The problem focuses on quality control and quality assurance, material system, change management, etc. The major defects are the consistency of production process and the reliability of data. All the problems found in overseas inspection are dealt with according to law. 

 

Also 2016 on foreign regulators or international organizations in China such as drug GMP inspection work 81 times of observation, involving 76 enterprises, including an API inspection, a total of 62 times, accounts for about 69% of all check number, API proportion still is the largest. The inspection involves 12 international organizations, including the world health organization (WHO), or foreign regulators. Nine of these companies were found to have serious defects and data reliability problems were more prominent. 

 

▍ inspection plan 466 drug firms in 2017 

 

In 2017, the state department of pharmaceutical inspection plan inspection on 466 pharmaceutical producing enterprises, including 316 to monitor production enterprises, 150 "double random" check all kinds of production enterprises. 

 

Check the key for vaccines and blood products production enterprises, one year to sample found unqualified varieties, adverse reaction monitoring found that serious adverse events or warning of varieties of production enterprises, all kinds of inspection not passed or been issued warning letter enterprise, part of the special varieties and risk signal concentrated production enterprises, and according to different level of risk and variety characteristics of the implementation of layered double random part of the Chinese medicine yinpian, biochemical drugs, using traditional Chinese medicine extract production enterprises, etc. It will also continue to conduct flight inspections around drug production and circulation.