The Application Research Of Pharmacoeconomics In Drug Registration Of China

OBJECTIVE:The thesis aims to explore the necessity and feasibility of the Pharmacoeconomics applied to the drug registration of China, and researches the application methods of the Pharmacoeconomics in new drugs, generic drugs and changed dosage forms drug registration, construct management mode for the application of pharmacoeconomics in drug registration of our country.METHODS:Make clear the theoretical, evaluation method and the development and application status at home and abroad of pharmacoeconomics by documents collecting. Learn the related laws and regulations, official request for the declared data and run program of the drug registration and the applicant's registration in our country by investigating Drug Registration and safety supervision department of Sichuan Food and Drug Administration (SCFDA) and part of enterprises which research, produce and run drugs to discover the problems existed in drug registration and advance some countermeasures to solve them. Make clear the form, content, evaluation methods and organization settings by communicating with review experts and tracking the center for drug evaluation, SFDA. Finally, search referential experience by comprehensively analyzing and comparing the difference of the Application of pharmacoeconomics in domestic and international.RESULTS:Through analysis and study above, we found the necessity of the application of pharmacoeconomic in the drug registration of China from optimizing the allocation of drug resources, improving pharmaceutical companies'ability to resist risks, exploiting the government's guidance and solving the historical problem of drug registration left. Obtain the feasibility of the application of Pharmacoeconomic in drug registration from the existing technology base, institutional base, personnel and policy foundation basis. It's found that the drug safety, efficacy and quality control affect the economy of drug directly or indirectly by analyzing the relationship between Pharmacoeconomic evaluation and others. Pharmacoeconomics Theory can explain the evaluation content of Pharmacoeconomic which is applied on new drugs, generic drugs and changed formulations drugs. Finally, Construct an application management in drug registration of China from the guiding principles, institutional, technological system, staff training, running process in drug registration and so on. CONCLUSION:In theory, the application of Pharmacoeconomic in drug registration could help us improving the level of the pharmaceutical research and the rate of regulatory approval to market in our country. At the same time, it is also good for health resources conservation and reasonable use. With the short time for Pharmacoeconomics came into China and relatively weak base for the existing talent and technology resources, our government should gives high importance to the application of pharmacoeconomics in drug registration of our country, such as add the Pharmacoeconomics content to the measures for the administration of drug registration, to make sure that the practical application of pharmacoeconomics goes well and has caused wide public concern in scientific research institutions, manufacture and the all medicine field.