【摘要】 通过对创新性化学药品在注册申请过程中向企业发出补充通知要求补充资料的情况进行系统性分析,探求影响创新性药品技术审评效率的制约因素。研究结果表明,即使通过召开会议审评机构与制药企业之间的交流后,仍有47.3%的品种需要补充资料,使审评中位时间延长5个月。更多还原

【Abstract】 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.更多还原