Analysis And Thinking On European,American,and Chinese Drug Registration Fee Regulations

Fees for drug registration are international practice,and drug registration related fees will be inevitably involved when registration is conducted.China is a big producer of API,and is one of the major exporters of API in the world.The sales markets are all over the worlds,thus,the registration is all over the world,so registration related fees will be inevitably an integral part.Now,main countries and areas in the world have formed systematic registration payment rules gradually,which is to provide financial support for drug registration review activities.This paper analyzed the experience that can be learned by Chinse drug registration payment rules from Europe and America,provided enlightenment for the improvement of the Chinese payment regulation,thought about the influence on Chinese API enterprises by drug registration payment rules of these countries and areas,and provided reference advice for the drug registration of API enterprises through the comparison of the payment rules in Europe,America,and China.The illustration,literature anyasis,historical approach,systematic approach,comparative analysis,and other research methods were used in this paper to investigate the differences of the payment rules in Europe,America,and China.Trough the comparison of payment rules in Europe,America,and China,the registration fees achieved results,and the influence on API enterprises,it can be concluded that we can learn from the experience of Europe and Ameica in the aspects of dynamic charge,detailed charging rules,optimization of fee structure,establishment of special funds for fees to improve the payment regulation of our country,and our API enterprises need to adopt different registration strategies according to different markets.