Again, FDA has updated the Providing Regulatory Submissions in Electronic Format guideline. Now, the requirement to submit DMF Type III (Packaging Material) electronically (in eCTD format only) become effective 60 months after May 5, 2015 (May 5, 2020).
Health Canada has updated the timeline for Mandatory Use of eCTD Format for Types of Regulatory Activity.
From since 2004, Health Canada is accepting regulatory activities in eCTD format. As of December 2018, 93 percent of regulatory activities (Part C, Division 8 of the Food and Drug Regulations, for human drugs) have been submitted in eCTD format.
- 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;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: