Review of Japanese Charge Standard for Drug Registration and Its Enlightenment to the Improvement of Corresponding Charge System in China / 中国药房

ABSTRACT

OBJECTIVE:To provide reference for improving the charge system of drug registration in China so as to promote work efficiency and quality of drug registration. METHODS:Through comparing the implementation of drug registration and evaluation in Japan and China(registration institution,process,cycle,etc.),Japanese charge standard of drug registration system was evaluated and its characteristics were analyzed,so as to put forward the suggestion for charge standard reform of drug registration in China. RESULTS & CONCLUSIONS:Japanese drug registration was internal review, with the independent administrative institution Pharmaceuticals and Medical Devices Agency(PMDA)as main body,combined with the opinions of the external experts;there was a strict control standard for the registration cycle. Specific fee was confirmed by the charge standard according to new drug registration,drug re-registration,first application,extension application,first or second category of drugs, orphan drugs or non-orphan drugs. Japanese charge standard was characterized with clear classification of charge standard,high fees, close relationship of charge level with drug types. The procedures for drug registration were more cumbersome in China,and involved more relevant institutions and personnel at different levels;there was not strict restriction on registration period;relatively rough charge standard,low fee and not detailed charge classification also existed. It is suggested to draw lessons from the experience for charge standard formulation and management of drug registration in Japan,improve the current drug registration charge system in China by adding charge standard of drug registration into annual report of Center for Drug Evaluation,raising the amount of fee, subdividing the charge items and setting up the feedback mechanism,which lay a solid foundation for improving the efficiency and quality of drug registration in China.