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CDE Consults on the Structure of Electronic Common Technical Document (eCTD) for Drug Registration

 John Li  2017-11-14    2017-11-24

The Center for Drug Evaluation (CDE) affilated with CFDA is inviting public comments on the structure of electronic common technical documents (eCTD) for drug registration. CFDA is currently in the process of standardizing the electronic submission content of drug registration dossier. Industry can submit their comments to CDE before 18 Nov 2017.

This marks a big step for China to move towards accepting eCTD submissions. The eCTD format consists of 5 modules and is developed based on ICH guidelines. Each module includes dozens of endpoints. The 5 modules are: administrative info, summary and overview, pharmaceutical research data (CMC), non-clinical research data (pharmacology and toxicology), and clinical data.



联 系 人:李海玲 , 电子邮箱Email:lihl@cde.org.cn



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