Study On Management System Of National Drug Evaluation Program

Drug is a special commodity, it relates to people’s life.In our country, the number of pharmaceutical manufacturers and drug varieties are very huge. But it tended to simple repetition and the technological level is low. How to deal with the situation of uneven drug quality is a great challenge for drug administration department and drug control institution. In recent years, national drug evaluation program was introduced to evaluate and grasp the overall quality level of drug and played an important role. But it should be pointed out that after years of the system in the execution, it has exposed some problems. The situation of how to carry out this program preferably and optimize and improve it is extremely urgent. This research aims at carding the national drug evaluation program and put forward advise and strategy for improving the system.The theoretical basis of this research is scientific inspection spirit and the concept of Quality by Design. And discuss how to improve and perfect the system of national drug evaluation program with this theory. This research aims at making the national drug evaluation program play a role preferably in drug surveillance and ensure the safety use of drug for the public.This research uses questionnaire survey research method to illuminate institute for drug control and pharmaceutical manufacture’s attitude and viewpoint for national drug evaluation program. The questionnaires obtain some existing problems and improved proposal for the program. Literature research and comparative research methods were employed to give a detailed introduction of EU Centrally Authorised Products sampling program and compare the two programs between China and EU to reference the concept and method. This research also uses case study method to elaborate national drug evaluation program of nitroglycerin tablets and nitroglycerin injections. We can perceive some effect of the program and certain problems such as sample guarantee and outcome utilize through these cases.The results of this study indicate that the system of national drug evaluation program exist some problems and need to amend. The suggestions for improvement this program are based on scientific inspection spirit and the concept of Quality by Design.1. The segment of plan for national drug evaluation program should have a scientific designing. The kind and number of samples should be determined reasonable. And the design of experiments should complete ahead of time. We can redeploy pharmaceutical manufacture’s will of coordinate the program. We should also do the work of international exchange and use foreign analogous work experience for reference.2. The segment of sampling for national drug evaluation program should make sure the sample guarantee.3. The segment of testing for national drug evaluation program should make a reasonable plan. We should accomplish company survey and design the period of experiments. And we also can think about add organizations of sample testing for enhance work efficiency and quality.4. The segment of outcome utilizing for national drug evaluation program should do enough so that can transform with other programs and use results for drug administration and pharmaceutical manufacture. We also should make a data sharing platform for drug administration so that can use the results maximum.