Singapore HSA Announces eCTD Format Officially Accepted for Therapeutic Products Regulatory Dossier Submission
Singapore HSA announces that electronic Common Technical Document (eCTD) format will be officially accepted for Therapeutic Products regulatory dossier submission …
China NMPA Implements Drug eCTD Submission
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 …
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 …
Australia TGA’s Staged Transition to eCTD-only for Prescription Medicines from 1 November 2020
This transition will see Australia adopt best practice standards that are currently applied across the world. Providing benefits for both …
Taiwan FDA Issues eCTD Specifications and Validation Criterion
In order to promote Taiwan’s adoption of ICH Electronic Common Technical Document (eCTD) format of , applicants will be able …
Implementation of eCTD for Clinical Trial Applications in Canada
Health Canada would be accepting certain clinical trial submissions in the format of electronic common technical document (eCTD) from 19 …
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