On May 31, the state administration of food and drug administration released the annual drug inspection report 2016. Report, carry out 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 of check and observation check 434 items. Among them, the intensity of flight inspections has increased year by year, and the GMP certificate has recovered 50 from 2014 to 172 in 2016. 

 

Drug administration of the state food and drug supervision and administration of the supervision department jian-hua ding pointed out that "the flight check is raids, don't say" hello ", the purpose is to monitor the production behavior continued compliance." He said, the product quality is designed, and produced, only production enterprise daily production is in strict accordance with the GMP regulations, all production records are recorded accurately and timely, all data can be traced back to ensure drug quality, to ensure the safety of the public administration. 

 

Besides, is there any plan to cancel GMP and other four certificates after the cancellation of GAP certification? What is the general direction of future drug supervision? 

 

Mr Ding said that the work was proceeding vigorously, and that overall it was strictly in accordance with the state council's requirement for further examination and approval reform. It is important to note that the administration has been able to eliminate or delegate some administrative licensing to the provincial bureau in recent years through the efforts of the steps in stages. As of January 1, 2016, the general administration of the general administration of China will no longer accept the application for GMP certification, which will only apply to the 16 certified applicants that have been accepted by 2016. 

 

The first "double random" check 

 

According to understand, to implement the innovation matter, afterwards regulatory requirements of the state council, administration of unified deployment, based on risk mode of "double random" drug inspection, 13 companies to carry out the trace of randomly selected examination, including 2 3 chemicals, active pharmaceutical ingredients, proprietary Chinese medicine eight, distributed in 9 provinces, a total of 4 companies don't pass, pass rate was 69%, the other three companies to issue a warning letter. 

 

Jian-hua ding said, "double random method application of strong shock the not compliance behavior of enterprises, found that the problem is more scientific and efficient, is conducive to the regulator to run in front of the risk." 

 

Administration of state food and drug supervision and administration of drugs, and supervision, deputy director of the Sun Jinglin introduction, double random is according to the product risk and inspector and professional ability, establish stratified random internal procedures, to establish an inspector check the object database and database can be according to the way of stratified random sampling to check province, inspected enterprises, and the inspector, the inspector strictly implement HuiBiZhi, ensure inspection sunshine, justice. 

 

In addition, in order to ensure the authentication down after the provincial standard unified, administration issued a guidance document, the provincial bureau to perfect and improve the certification inspection quality management system, strengthen construction of ability of inspection quality certification inspection work. In 2016, the general administration of general administration of the state administration of pharmaceutical and drug administration (sappra) carried out follow-up inspections of 21 sterile pharmaceutical companies that were examined by the provincial bureau of medicine certification. The results were all approved. 

 

2016 administration still focus on 2015 annual 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 (bone peptide, fructose ErLinSuanNa, citicoline sodium) 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. 

 

In article 204 check-up found 204 defects, 22, and serious defects of the main defects of 210 items, 2039 general defects, compared with the GMP certification in 2015, the track inspection serious defects number increased. For checking the problems have been found in layered processing, require companies to rectification are sent a warning letter (a total of 58 warning letter), 13 companies, involving illegal column in the administration of the network to be open and ask ShengJu initiate an investigation, related company is voluntarily recalling involved product requirements. 

 

Start the drug circulation test 

 

The total number of GMP flights in 2016 has been completed and reported by the general administration of the general administration of the general administration of the general administration of the general administration 45 times, and the rest are conducted in 2017. 39 times has reported the results, including Beijing, jiangsu, guangdong and other 20 provinces (municipalities), including 9 biochemical drugs production enterprise, 20 Chinese medicine production enterprises, nine general chemical production enterprises and 1 blood products manufacturing enterprises. 

 

The reporter learned that the flight inspection mission in 2016 came from 33 tasks from the administration of the administration of drug administration, and the tasks of the bureau of pharmaceutical registrations from the general administration of the administration of the general administration of the administration of the administration of drugs were 6. The task of the administration of pharmaceutical control is about 85%, which is the main source of flight inspection. Chinese medicine accounted for 51 percent of all flight tests and 23 percent of general chemical and biochemical drugs. 

 

As a result, a total of 21 drug production tests were not approved in 2016, accounting for 54% of the total. Of these, 14 companies have been retracted from the GMP certificate, 10 have been investigated and seven companies have been ordered to recall their products. In drug GMP flight check, traditional Chinese medicine and biochemical drugs found more problems, more is unauthorised changes to the process of proprietary Chinese medicine production enterprises 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 weak and 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. 

 

In addition, the administration of 2016 deployed in circulation to carry out illegal conduct centralized regulation, has sent 20 flight inspection group of 30 provinces has carried on the flight check 50 pharmaceutical wholesale enterprises, to found a violation behavior of the 38 companies issued a notice to be exposed, and requires ShengJu is investigated. Sun Jinglin pointed out that GSP defect is mainly focused on the general medicine circulation enterprises, storage, sales and maintenance aspects: first, does not operate in accordance with the law, are false and deception; Second, failing to store the drugs in accordance with the provisions and not effectively monitoring and regulating the temperature of the warehouses; Article 3. When buying and selling drugs, the ticket, account, goods and funds are inconsistent, and the sales of special drugs shall not be enforced by the state. 

 

Overseas inspection varieties are the main ones 

 

Administration of state food and drug supervision and administration of drugs, and supervision in drug production supervision Cui Hao introduction, "imported drugs overseas examination in 2016 following the inspection service based on the principles of drug approval for examination and approval, products mainly for the port inspection and has a high risk of adverse drug reactions monitoring varieties. Comprehensive inspection tasks appear varieties, dosage form widely etc., and stepping up efforts to the extension of chemical drug preparations check." 

 

According to the report, 2016 overseas tasks involved in 19 countries, covering both developed countries and developing countries involved, increased in South America and Oceania inspections at the same time. 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. 

 

In 2016, we completed 81 inspections of GMP inspections conducted in China by foreign regulators or international organizations, involving 76 enterprises. Of these, the total number of tests involving raw materials was 62 times, accounting for 69 percent of the total number of tests, and the primary drug was the largest. The inspections involved include 12 international organizations, including the world health organization (WHO), or foreign drug regulatory authorities. Among them, nine pharmaceutical companies were found to be seriously flawed and the reliability of data was outstanding. 

 

Jian-hua ding pointed out that the next step, the administration will actively promote the implementation of the 2017 national drug inspection plan, to further standardize production, purify the market order, fight system risk. 

 

2017 national drug inspection plans to follow "on the basis of risk, in order to breed as the main line" principle, strengthen risk control problems, the guidance, take the "double random" "look back" in a variety of ways, such as inspection on 466 pharmaceutical producing enterprises, including drug to monitor production enterprises, 316, 150 "double random" check production enterprises. Check point for all vaccines and blood products, one year is to sample found unqualified varieties and adverse reaction monitoring found that serious adverse events or warning events 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 risk levels 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. At the same time, we will continue to carry out flight inspections around drug production and circulation.