Research On The Transparency Of Chinese Drug Regulation

[Objective]The transparency of drug regulation is of great importance to improve the administrative ability and level of the pharmaceutical supervision department and increase public credibility.This study based on the analysis of status of our country's drug regulatory transparency,the drug regulatory transparency of the macro policy and practice process,every link of drug regulatory and medicines GMP flight check of the public's perspective,evaluation of drug regulatory transparency in our country,for the agency to make drug regulatory transparency improvement measures to provide the basis.[Methods]The main research methods used in this study include literature research,panel discussion,content analysis and poisson regression.Specifically,(1)Through literature research,the author analyzes the status quo of China's drug regulatory transparency,the framework,dimensions and items of the meta-tool and GGM evaluation tool.(2)Through the panel discussion method,further confirmed MeTA tool with GGM dimension and meaning items of assessment tools,can be used for evaluation of drug regulatory and transparent policy,practice,the results of evaluation and drug regulatory each link of the open and transparent;(3)Through the content analysis method to the state food and drug administration and drug administration of provinces and cities,about the flight check online publicity result is analyzed,and using poisson regression analysis the influence factors of enterprise flight check.[Results](1)For drug regulatory transparency status quo analysis,this study found that:(1)China's drug regulatory transparency into era,there are laws to feed since 2017 the state council general office and the state food and drug administration has launched three areas to ensure drug quality and safety of regulations and information publicity work;(2)The preliminary formed a set of drug regulatory transparency system and operation methods,in terms of national food drug administration public subject,in its food drug administration in2018 the government information disclosure catalog stipulated in the active public permits include policies and regulations,service and 19 items,with responsibility for the content and made clear the specific public sector;(3)There are more and more open channels for the state food and drug administration,and the new media platform is fully utilized.In the light of the "policy,practice and result" evaluation of the transparency of drug regulation,this study finds that(1)The legal policy system related to drug regulation is relatively perfect.In view of the policies related to information disclosure,in line with our country on the basis of analysis of drug regulatory transparency,increasing of quantity information public policy in recent years,the drug regulatory transparency and disclosure regulations gradually clear the responsibility of the department;(2)Jordan,Nigeria and Ghana and other seven countries,China's drug regulatory information disclosure is very sufficient,medicines transparency alliance "practice" 34 evaluation index,there are 26 indexes closed to the public in China,but the agency still need to strengthen public content including the composition of drugs price,the number of drug outlets for inspection/audit,and pharmacies,private hospitals,relevant departments such as purchasing department of drug kinds,quantity and price,etc;(3)The analysis of the "results" of the transparency"results" of the drug administration found that there are many problems,such as complex information content,limited data disclosure,some inaccessible websites,and low awareness of public awareness.According to the public and transparent evaluation of various aspects of drug regulation,this study found that(1)The evaluation result of GGM assessment tool at the national level was 7.63,which was very transparent.Each step(2)Drug regulatory transparency,transparent sequence from high to low in turn is drug license,drug clinical trials,the basic drug selection,drug inspection and market management,drug registration,drug distribution,drug procurement,drug sales,score of 9.22,8.81,8.00,7.78,7.25,6.77,6.62,6.77,in addition to the drug license belongs to highly transparent and drug clinical trials,other are all very transparent.(3)In each link to evaluate five entries(national lawsand regulations and official documents,written procedures and decision-making,organization and employee standard,a conflict of interest statement,appeal mechanism),this study found that "conflict of interest statement" aspects of the public is one of the biggest problems,followed by "organization and employee standard" and "written procedures and decision-making process.(4)For drug flight check transparent evaluation,this study found that:(1)Open body and path mainly is the state food and drug administration and 31 provinces and cities to eat the food and drug administration's official website,the Tibet autonomous region,xinjiang uygur autonomous region did not find any pharmaceutical production enterprise administrative supervision and inspection results of the public information,thus effective public main body and the path to 30.(2)The results of the flight inspection of the state food and drug administration shall be the basic information of the enterprise,the inspection of the cause,the inspection of the problems,and the inspection and treatment measures,and there is a fixed public form.At the provincial and municipal level,the public content is missing more and the form is more chaotic.Possion(3)About the influence factors of examination question analysis,regression analysis shows the following statistically significant: according to the area to which the enterprise belongs,eastern and central enterprises more than the western enterprise inspection(RR = 0.839,P = 0.839).According to the enterprise type,the number of examination problems of Chinese traditional Chinese medicine decoction enterprises was significantly higher than that of common drugs and biological products(RR=0.481,P=0.025).For the reason of inspection,the enterprise inspection problem of "complaint reporting" is significantly higher than that of "special inspection","sampling inspection" and other inspection reasons(RR=1.129,P=0.001).In the light of the inspection date,when the flight inspection was started in 2014,the number of inspection problems was significantly lower than that in 2017(RR=-1.133,P=0.013).[Conclusions](1)The quantity reaches a certain level of drug regulatory transparency policy,tend tobe more specific,refined and precise,and form a complete set of supervision and relief system gradually established,but the lack of information disclosure stable long-term mechanism;On the basis of most regulatory lists,processes,and results,there is still a need to strengthen disclosure in areas such as drug prices.(2)The overall drug regulation of the country and the evaluation of each link are very transparent.We should attach importance to the disclosure of "conflict of interest statement","organization and staff standards" and other aspects in each link.(3)The results of the flight inspection of the provinces and cities are more chaotic,and the public content is less than that of the state food and drug administration.In addition,the enterprise type,inspection reason,inspection date,and the area of the enterprise are related to the enterprise flight inspection.