Taiwan FDA to Start Pilot Testing of eCTD Submissions 

On 22nd March 2021, Taiwan FDA announced a plan on pilot testing of eCTD submission.  

To ensure that the eCTD submission platform functions smoothly, Taiwan FDA will conduct pilot testing from Q2 of 2021. Interested companies can apply to participate in the pilot by submitting the application form from 1 April 2021. The actual testing date will be agreed thereafter. 

The focus will be on understanding whether eCTD submission packages from different companies’ eCTD software can fulfil the agency’s eCTD specification and validation criteria regardless of whether it is uploaded or submitted using CD/DVD to the ExPRESS platform. 

More details are found on the Taiwan FDA website: 


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