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 during the initial implementation period. The requirement for mandatory submissions will be reviewed at a… Continue reading Planned eCTD Implementation in Singapore
Year: 2018
US FDA Updated eCTD Technical Conformance Guide (v1.3)
FDA has updated the guideline for eCTD Technical Conformance Guide (v1.3). In this version FDA; Updated/Clarified following sections;
US FDA Updated eCTD Module 1 Specifications Version 2.4
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: