- 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.
- The requirements for baseline submissions (quality dossiers) for currently registered products will be reviewed at a later date.
FDA has updated the guideline for eCTD Technical Conformance Guide (v1.3). In this version FDA;
Updated/Clarified following sections; (more…)FDA has updated the guideline for module 1 specifications version from v2.3 to v2.4.
Summary of Changes for Version 2.4Added eCTD Submission Type ‘REMS Supplement’. The updated sections are listed below:
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