我国正式实施eCTD后药品生产企业的注册申报应对策略

Countermeasures for registration application of drug manufacturing enterprise after the official implementation of eCTD in China

研究我国药品生产企业(以下简称为药企)在药品电子通用技术文档(eCTD)正式实施后可能面临的困难,并提出应对策略。介绍eCTD的起源及演进,及其在国外主要国家的情况,并对国家药品监督管理局(NMPA)发布的相关指导原则进行介绍,分析我国药企在进行eCTD注册申报过程中可能遇到的问题并提出应对措施。eCTD已在世界范围内得到广泛应用,我国发布的eCTD指南参考的是ICH发布的V3.2.2版本。eCTD有助于提高药品申报效率,但其制作难度大、专业性强,制药企业应当做好早期规划,尽快完善企业内部eCTD注册申报体系建设,以积极心态迎接eCTD时代的到来。

The aim of the article was to study the difficulties that Chinese drug manufacturing enterprise(hereinafter referred to as drug enterprise)may face after the official implementation of electronic common technical document(eCTD),and to propose countermeasures.The origination,development and global implementation of eCTD were introduced,as well as the relevant guidelines issued by NMPA,so as to analyze the possible problems in the process of eCTD registration application of drug enterprise in China and put forward relative countermeasures.eCTD has been widely used in the world.The eCTD guidelines published in China was established based on V3.2.2 version issued by ICH.eCTD helps to improve the efficiency of drug application but is difficult to develop and has high professional requirements.It is advisable for drug enterprise to make early planning,complete the construction of eCTD registration application system as soon as possible,and prepare the arrival of the eCTD era with a positive attitude.