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.
Author: masuuglobal
US FDA Extended eCTD Deadline for Type III DMFs (Packaging Material)
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 updated notice for Mandatory use of eCTD Format
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… Continue reading Health Canada updated notice for Mandatory use of eCTD Format
Planned eCTD Implementation in Singapore
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
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: