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Update on eCTD submissions in China: “M4 Module 1: Administration documents and drug information” document is available

Posted on July 6, 2020

The Center of Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has issued the “M4 Module 1: Administration documents and drug information”, which took effect on July 1, 2020.

This is the result of the activities the NMPA began in April 2020, when they started to solicit public comments on the draft version of several documents. For more details on this, have a look at our previous blog post.



In line with the overall timing laid out in “Measures for the Administration of Drug Registration”, on June 30, 2020 the NMPA also issued the “Registration Classification and Requirements of the Submission Materials for Chemical Drugs” and the “Registration Classification and Requirements of the Submission Materials for Biological Drugs”, which require the registration classification of biological and chemical drugs starting on July 1, 2020. Their corresponding submission material requirements take effect on October 1, 2020.

In general, all submission materials must meet both the general CTD requirements as laid out in “M4: General Technical Document for Application of Human Drug Registration (CTD)”, and also meet any specific content requirements outlined in the regulations and technical guidelines, which are updated continually.

Milestones in China's eCTD implementation 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.
  • April 17, 2020
    Release of the “M4 Module 1: Administration documents and drug information” for public comment.
  • April 30, 2020
    Supporting documents made available for public comment.
  • June 30, 2020
    “Registration Classification and Requirements of the Submission Materials for Chemical Drugs” and “Registration Classification and Requirements of the Submission Materials for Biological Drugs” published by the CDE.
  • July 1, 2020
    “M4 Module 1: Administration documents and drug information” published by the CDE.

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

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