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EMA Publishes First EU eCTD v4.0 Validation Criteria and Updated Controlled Vocabularies
In 1st & 8th August 2025, the European Medicines Agency (EMA) announced two major milestones in the transition to electronic Common...

Sharan Murugan
Aug 10, 20252 min read


Singapore's HSA: Post-Industry Consultation Updates on eCTD Implementation in Singapore
On 11th December 2023, Singapore's Health Sciences Authority (HSA) released an update "Post-Industry Consultation Updates on Electronic...

Sharan Murugan
Dec 11, 20231 min read


Swissmedic: eCTD v4.0 Implementation Guide published
Earlier today (17 March 2023) Switzerland's SwissMedic released published the "Implementation Guide for eCTD v4.0" and the implementation...

Sharan Murugan
Mar 17, 20231 min read


USFDA Guide: Updated eCTD 4.0 - TECHNICAL CONFORMANCE GUIDE,
Recently USFDA released an updated "Electronic Common Technical Document (eCTD) Technical Conformance Guide" that revised some sections...

Sharan Murugan
Sep 17, 20221 min read
