SAPHRA News: Implementation of RIMS – Information on eCTD 3.1 Module 1
Australia TGA: eCTD AU Module 1 and Regional Information v3.2
USFDA Guidance: Providing Regulatory Submissions in Electronic Format Using eCTD Specifications
South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template
Health Canada: Guidance on Preparation of Regulatory Activities in Non-eCTD Format & Filing submissions electronically
Swiss Medic: eCTD Guidance for Industry & Time limits for Authorisation Applications
Australia TGA: eCTD AU module 1 and regional information
Singapore's HSA: Post-Industry Consultation Updates on eCTD Implementation in Singapore
Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format
TGA Guidance: Submitting data in the eCTD format
Health Canada Guidance: Preparation of Regulatory Activities in Non-eCTD Format
South Africa's SAPHRA: Updated Medicines Application Form Module 1.2.1
South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS
Singapore's HSA: Consultation on eCTD Implementation & Risk Classification on IVD
USFDA Guide: Updated eCTD 4.0 - TECHNICAL CONFORMANCE GUIDE,
USFDA Guidance on Providing Regulatory Submissions in Alternate Electronic Format
Providing Regulatory Submissions in Alternate Electronic Format – US FDA
Australian electronic Submission Basics Guide- Australia (TGA)
Guidance on Providing Regulatory Submission in e-Format for Standardized Study Data -US FDA
Submitting data in the eCTD format - Therapeutic Goods Administration - Australia