On 30 September 2021, China NMPA issued an announcement No. 119 of 2021 regarding implementation of drug eCTD submission.
From December 29, 2021, applications for marketing authorisation of chemical drug categories 1, 5.1, and for therapeutic biological products category 1 and preventive biological products category 1 can be submitted in accordance with eCTD.
The applicant should prepare and submit the eCTD application on CD in accordance with the eCTD technical documents (attached in the announcement as Annex 1-4), and submit the paper documents within 5 working days after the eCTD registration application is accepted. If the applicant fails to submit the paper documents within the prescribed time, the application will be handled in accordance with the procedures for terminating the drug registration application. At the same time, the applicant should declare that the submitted electronic documents are completely consistent with the content of the paper documents, and the applicant will bear responsibility for any issues arising from the inconsistency.
In order to ensure the steady implementation progress of eCTD and reduce the impact on the application process, applicants can still choose the existing application method for registration applications for the above mentioned types of applications.
For eCTD applications, the applicant does not need to separately submit the CD of data materials for verification and inspection and CD of clinical trial database.
Related technical guidelines can be found on the website of the Center of Drug Evaluation of the NMPA.
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