Study On Measures And Current Situation Of Drug Re-registration Application In Anhui Province

Objective To Summarize the development of Drug Re-registration Application and supervision system in our country,this paper will discuss the current situation of drug Re-registration Application nearly three years in Anhui province,analyze the problems that existing.for the deep understanding the meaning of the drug registration work,and improve the quality of drugs registration work in Anhui province,to promote the standardization of the drug registration,scientific and medical countermeasures to sustainable economic development.Methods 1.Literature review method: systematic search Wanfang,CNKI,VIP database and Pubmed for the related literature of Drug Re-registration Application,with a review of the literature and analyzes Drug Re-registration Application status of supervision and examination in our country;This paper summarizes the review conclusions of Drug Re-registration Application in Anhui province from 2014 to 2016 and analyze the current status and existing problems of registration.2.Questionnaire survey and expert interview method: A questionnaire on drug reregistration in Anhui province was designed according to the literature review and law regulations,the people that was in charge of applying for the drug re-registration in Anhui province were investigated after the Delphi method was used to make the modification.The interviews with five registered experts of the food and drug administration of Anhui province was conducted.Then the results were analyzed.3.Data treating and statistical analysis methods:Using Epidata to collect the data for the questionnaire of this study,statistical analysis was performed using SPSS17.0 software.the description of the count data using the constituent ratio indicators.Results 1.Through the literature research on the re-registration of drugs in recent years,it is found that the re-registration work has played a positive role in regulating the post-marketing drug regulation.But there are also common problems:The applicant does not attach importance to drug re-registration,There is a lack of uniform standards for drug re-registration,It is out of line with the Post-marketing drug re-evaluation.There is a risk of allowing the re-registration of perennial non-production varieties.There is a tendency to become formalistic.2.From 2014 to 2016,5192 applications for Drug Re-registration Application were accepted in Anhui Province,5,056 applications were completed,51 of which were not approved by the Ministry of Health,and 2859 perennial unmanufactured products reached 56.2% of the total number.Large number of Drugs accepted are varieties of old and low technical.Tablets and injections are main dosage forms.Drug Re-registration Application in foreign countries: Japan and the United States did not carry out,but Japan has the market Re-examination and re-evaluation,the United States have an annual report system,the EU have work of Drug Re-registration Application,but each approval number requires only once of re-registration.3.When reviewing the application for Drug Re-registration Application,the problems identified mainly focus on the following:the application information are not completed,incompleteness of the submitting documents and materials,simplifying the summary of the adverse reactions,providing the information in the original documents that the work needs to be completed,quality standards implementation,providing Drug prescriptions and production process steps and parameters,the source of raw materials.4.The results of questionnaire survey can be seen in the aspect,the vast majority of drug manufacturers are limited companies(86,accounting for 79.6%),and there are only 2 listed companies.Geographical distribution is mainly concentrated in northern Anhui(47,accounting for 43.5%),Hefei has the most number of pharmaceutical companies.(23,accounting for 21.3%).In setting up the registration department,46 pharmaceutical companies were not set up.The total number of people engaged in drug registration was 383,with more part-time staff(203,accounting for 53%).In the process of re-registration,the reasons for the temporary failure to obtain the approval document,quality standard accounted for up to a total of 49.In terms of the need for a more detailed explanation of the content of the declaration,the choice would be of the highest frequency(52,49%).In regard to the new trend of drug policy,generic drug conformity assessment accounted for up to a total of 54.Conclusion At present,after two rounds of large-scale centralized examination of drug re-registration in our country,on the one hand,the situation of Post-marketing drug quality supervision has been regulated,on the other hand,the problems and contradictions in this work have become increasingly prominent.The proportion of drug re-registration products in Anhui Province is not high in the country,the varietiesare low-tech.Although the ratio of non-passing is very low in three years.There are many problems in the review process.