Michele Manetti -

As of 29 December 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, according to the last disposals of Chinese National Medical Product Administration (NMPA).

In particular the applicants should prepare and submit the eCTD application dossiers on CD-ROM as required by the eCTD technical documents and submit the paper dossiers within 5 working days upon the acceptance of the eCTD registration application dossiers.

If an applicant fails to submit the paper dossiers within the specified time, the drug registration process will be automatically terminated.

At the same time, the applicant should make a commitment that the electronic dossiers submitted is completely consistent with the paper dossiers with the applicant that should bear the responsibilities for any problem arising from the possible inconsistency.

However, in order to ensure a steady promotion of the eCTD and minimize its impact on the application, applicants can still choose the existing registration method for the above registration applications.

The relevant technical guidance may be accessed on the website of the Center for Drug Evaluation of NMPA.

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