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Update on eCTD submissions in China: Chinese CDE conducted eCTD Pilot

Posted on January 15, 2020

The CDE, China's regulatory agency conducted an eCTD pilot from November 25th through December 4th 2019. A selected number of industry companies were nominated to submit electronic submissions in eCTD format (CN v1.0 DRAFT).

Several of the selected companies were LORENZ customers, and they were able to use docuBridge (both cloud and on premises versions) to publish and submit their test eCTDs to the CDE. Feedback indicates that the process ran efficiently and without any problems.

We understand that the CDE is now sharing its experiences with the pilot with the NMPA and will soon be specifying next steps.

Milestones of eCTD implementation in China to date:

  • March 1, 2019
    First versions of the eCTD specification, validation criteria and related documents were published for public comment.
  • March 18, 2019
    CDE published some translated ICH documents for public comment.
  • April 11, 2019
    NMPA published its eCTD M1 requirements and translated version of ICH M2-M5.
  • July 28, 2019
    2nd round of industry comments covering the eCTD specification, validation criteria, and guidance for industry.
  • September 17, 2019
    The second version of eCTD specification was published by the CDE, including technical eCTD files. Public comments from industry were requested by October 17, 2019.
  • November 25 to December 4, 2019
    The CDE conducted its eCTD pilot.

This entry was posted in Regional News, Regulatory Affairs News.

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