FDA has updated the guideline for Specifications for eCTD Validation Criteria (V3.8). In this version FDA updated;
- Descriptions of the eCTD Validation Criteria of Error Codes 1734, 1735, and 1736 which support the Study Data Technical Conformance Guide
These Validation rules build on the information provided in Preparation of Regulatory Activities in “Non-eCTD Electronic-Only” format guideline.
The revised rules assist stakeholders in the preparation of regulatory transactions in Non-eCTD format.
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.