Notice on the Electronic Submission Requirements for Drug Registration Applications
Request Notice on the Electronic Submission Requirements for Drug Registration Applications
  • Local Title:关于药品注册申请电子申报有关要求的通知
  • Country/Region:Chinese Mainland
  • Competent Authority: Center for Drug Evaluation (CDE)
  • Type:Notice
  • Status:In force
  • Release Date:2022-12-02
  • Implementation Date:2023-01-01
Document
Language Source Title Access
ZH Official 关于药品注册申请电子申报有关要求的通知 Download
ZH Official 附件1 申报资料电子光盘技术要求 Download
ZH Official 附件2 药品注册申请电子文档结构 Download
ZH Official 附件3 承诺书 Download
Summary

As per the Notice, starting from Jan. 1, 2023, China mandates that all documents for drug registration applications, as well as supplemental documents sent during the review, shall be submitted in electronic format on compact disks, eliminating the need for paper-based submissions. 

The Notice also outlines the specified structure of application dossiers and technical requirements for the compact disks. 

Related article: https://baipharm.chemlinked.com/news/china-requires-electronic-submission-of-all-drug-registration-application-documents-from-jan-1-2023