Month: December 2018

Singapore HAS (Health Sciences Authority) plans to commence the development phase in 2019 in order to allow eCTD submissions by the end of 2020. eCTD will start with new original marketing applications (NDAs and GDAs). eCTD submissions will be voluntary…

FDA has updated the guideline for module 1 specifications version from v2.3 to v2.4. Summary of Changes for Version 2.4 Added eCTD Submission Type ‘REMS Supplement’. The updated sections are listed below: ‘REMS Supplement’ added in Submission Types and Description…

FDA has updated the guideline for eCTD Technical Conformance Guide (v1.3). In this version FDA; Updated/Clarified following sections; Section Number Updation and Clarification Section 2.5 (eCTD Submission Tracking and Life Cycle) Heading name updated from eCTD Life Cycle to eCTD…