Announcement on Implementing the Application with Electronic Common Technical Documents
Request Announcement on Implementing the Application with Electronic Common Technical Documents
  • Local Title:国家药监局关于实施药品电子通用技术文档申报的公告(2021年第119号)
  • Country/Region:Chinese Mainland
  • Competent Authority: National Medical Products Administration (NMPA)
  • Type:Notice
  • Status:In force
  • Release Date:2021-09-30
  • Implementation Date:2021-12-29
Document
Language Source Title Access
ZH Official 国家药监局关于实施药品电子通用技术文档申报的公告(2021年第119号) Download
EN Official Announcement on Implementing the Application with Electronic Common Technical Documents Download
Summary

According to the Announcement, from December 29, 2021, the marketing authorization of chemicals with Registration Categories 1 and 5.1, therapeutic biological products with Registration Category 1 and preventive biological products with Registration Category 1 may be applied according to eCTD.