SAHPRA eCTD Submission Updates

SAHPRA eCTD Submission Updates SAHPRA eCTD Portal Launch: Beginning October 1, 2024, SAHPRA mandates all applications to be submitted via its eCTD Portal. Through this portal, applicants can register, upload content, and manage submission sequences. Detailed instructions are provided in the SAHPRA eCTD Portal Process Guide.

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Categorized as eCTD

SWISSmedic updated M1 Specification (v1.4) and eCTD Validation Criteria (v1.4)

On 01 January 2019 the new Swiss Module 1 Specification for eCTD v1.4 is implemented. Both versions (v1.3 and v1.4) will be valid for a half-year period from 01 January 2019 to 30 June 2019. As from 01 July 2019 the Swiss Module 1 Specification for eCTD v1.4 must be used for all eCTD submissions.… Continue reading SWISSmedic updated M1 Specification (v1.4) and eCTD Validation Criteria (v1.4)

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

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