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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 102 min read
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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
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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
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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
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