- 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 later date.
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 of Use Table
- ‘REMS Supplement’ added as valid submission type for PAS and CBE-30 in Supplement-Effective-Date-Types and Descriptions of Use Table
- ‘REMS Supplement’ added as valid submission type for submission sub-types of ‘application’,
FDA has updated the guideline for eCTD Technical Conformance Guide (v1.3). In this version FDA;
- Updated/Clarified following sections;
Updation and Clarification
(eCTD Submission Tracking and Life Cycle)