Research on the Related Problems of Small Interfering Ribonucleic Acid R & D and Registration in China / 中国药房

ABSTRACT

OBJECTIVE:To provide reference for small interfering ribonucleic acid (SiRNA) R&D and registration in China. METHODS:The situation of SiRNA R&D at home and abroad were introduced,and problems encountered in the evaluation and approval process were summed up to put forward suggestions. RESULTS & CONCLUSIONS:SiRNA has developed slowly in Chi-na,with a gap of 5-10 years at least compared with foreign developed countries. The registration category of SiRNA is not clear;applicants lack of guidance documents;production workshop which meet requirement is in shortage;the efficiency of drug registra-tion allows of no optimism. It is recommended that pharmaceutical registration departments carry out the pilot reform for SiRNA registration,publish SiRNA registration guide,relax regulations for IND gradually,encourage applicants to participate in the inter-national multicenter clinical trials in order to improve the efficiency of SiRNA evaluation and approval efficiency.