Supplemental submission of application for investigational new drugs in China

We systemically analyzed supplement submission of application for investigational new drugs,which send from the Agency to companies.The aim of this paper was to analyze the factors that limit the efficiency of drug reviewing.The results showed that 47.3% applications should submit supplement materials to the Agency for making decision,although they had held the reviewing meeting and communicated with companies.This delayed the reviews of these applications for 5 months.