A Study On The Reform Of Local Drug Regulatory System In China

With the continuous development of the Chinese economy,the pharmaceutical industry is growing rapidly,the industrial chain has been unprecedented vigorous development,whether the type of drugs or the number of drugs,have achieved rapid growth.At the same time,the task of drug supervision is increasingly arduous.The successive drug safety incidents,such as poison capsule and poison vaccine,highlight the lack of drug supervision ability of local governments in China.Although our country will carry out the top-down institutional reform to the drug regulatory department every five years in the administrative system,but in today’s increasingly complex drug regulatory situation,it is difficult to meet the requirements of drug safety supervision simply relying on the administrative system reform,especially the local government as the "last kilometer" of drug regulatory policy implementation,to build a comprehensive and perfect local drug supervision Management system is very important.System refers to a whole formed by following a specific order and internal connection within a specific scope or the same category of things.From the perspective of a staff member in the front-line Department of drug supervision,this article studies the composition elements and reform of the local drug supervision system,finds out the corresponding countermeasures for further reform of the supervision system on the basis of the current model,so as to explore the improvement of the local government drug supervision system in China.This article takes Shunde District of Foshan City as an example to analyze the current situation and problems and reasons of drug regulatory system reform.For example,in terms of the administrative organization system of drug supervision,there are problems such as repeated reform of drug regulatory agencies,unreasonable function setting of drug regulatory agencies and insufficient resource allocation of drug regulatory authorities;in terms of the technical support system,there are problems such as unclear function positioning of drug inspection agencies,lack of attention to the monitoring of adverse drug reactions and backward information technology of drug supervision,etc Problems;in the aspect of human resource management system,there are some problems such as unreasonable structure of drug regulatory personnel,weak strength of drug regulatory personnel and lack of incentive mechanism for drug regulatory personnel;in the aspect of credit system,there are some problems such as lack of diversified subject and social governance,unscientific evaluation and publicity of credit rating,and drug credit reward and punishment system Imperfect and other problems.In view of the above problems,this article uses the research methods of literature research,comparative research,theory and practice,enumerates the advanced practices in administrative organization,technical support,human resources and credit system of drug regulatory system in developed countries and some regions of China,finds out the deficiencies in the current reform of local drug regulatory system,and grasps the focus and direction of the reform.In order to improve the local drug regulatory system in Shunde District,the article puts forward countermeasures and suggestions from four aspects.First,in the aspect of administrative organization and system reform,it is proposed that:(1)strengthen the self construction of drug administration department;(2)improve the organizational structure of drug regulatory at the grass-roots level;(3)change the way of drug regulatory;and(4)strive to improve the effectiveness of in-process and post regulatory.Secondly,in the aspect of technical support system reform,it is proposed that:(1)change the functional orientation of Institute for drug control;(2)strengthen the monitoring of adverse drug reactions and establish risk early warning mechanism;(3)use information technology to achieve intelligent supervision.Thirdly,in the aspect of talent strategy,it is proposed that:(1)establish professional inspector team;(2)adjust and optimize the structure and development mechanism of supervisors;(3)do a good job in policy system,technical position sequence and other incentive mechanisms.Fourthly,in the aspect of credit system reform,it is proposed that:(1)establish a diversified regulatory body of drug credit system;(2)attach importance to the dynamic credit regulatory mechanism;(3)improve the credit reward and punishment institution.