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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
UK MHRA Guidance: Electronic Common Technical Document (eCTD) Submissions Update
The Medicines and Healthcare products Regulatory Agency (MHRA) published a key update on 17 June 2025 , outlining revised requirements...
Sharan Murugan
Jun 18, 20252 min read
Health Canada: Validation Rules for Regulatory Transactions in eCTD and Non-eCTD Formats
Health Canada has released detailed guidances addressing the validation rules for regulatory transactions submitted in two formats: "...
Sharan Murugan
Jan 26, 20253 min read
SAPHRA News: Implementation of RIMS – Information on eCTD 3.1 Module 1
The South African Health Products Regulatory Authority (SAHPRA) has released a communication " Implementation of RIMS – Information on...
Sharan Murugan
Oct 27, 20242 min read
Australia TGA: eCTD AU Module 1 and Regional Information v3.2
The Therapeutic Goods Administration (TGA) of Australia has released the latest version, v3.2, (on 13 September 2024) of the eCTD AU...
Sharan Murugan
Oct 2, 20242 min read
USFDA Guidance: Providing Regulatory Submissions in Electronic Format Using eCTD Specifications
This Friday (13 Septmeber, 2024) the USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
Sep 15, 20242 min read
South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template
The South African Health Products Regulatory Authority (SAHPRA) has provided updated guidance for " ECTD Validation And Technical...
Sharan Murugan
Sep 9, 20242 min read
Health Canada: Guidance on Preparation of Regulatory Activities in Non-eCTD Format & Filing submissions electronically
Health Canada recently (13 May 2024) updated its guidance "Preparation of Regulatory Activities in Non-eCTD Format" (electronic Common...
Sharan Murugan
May 14, 20242 min read
Swiss Medic: eCTD Guidance for Industry & Time limits for Authorisation Applications
Swissmedic, recently published updated guidance on "Guidance Industry eCTD" and "Guidance on Time limits for Authorisation Applications"....
Sharan Murugan
Mar 29, 20242 min read
Australia TGA: eCTD AU module 1 and regional information
Australia's Therapeutic Goods Administration (TGA) released updated guidance "eCTD AU module 1 and regional information" on 30 January...
Sharan Murugan
Jan 31, 20241 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
Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format
Health Canada recently published an updated guidance on "Validation rules for regulatory transactions provided to Health Canada in the...
Sharan Murugan
Nov 30, 20231 min read
TGA Guidance: Submitting data in the eCTD format
Recently (7th Spetember, 2023) Australia's Therapeutic Goods Administration (TGA) released revised and updated guidance "Submitting data...
Sharan Murugan
Sep 11, 20231 min read
Health Canada Guidance: Preparation of Regulatory Activities in Non-eCTD Format
Health Canada recently (09 June, 2023) published an updated guidance on "Preparation of Regulatory Activities in Non-eCTD Format" that...
Sharan Murugan
Jun 17, 20231 min read
South Africa's SAPHRA: Updated Medicines Application Form Module 1.2.1
Recently (18 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Application form template...
Sharan Murugan
May 21, 20231 min read
South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS
Recently (05 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released the template "Validation Template For...
Sharan Murugan
May 9, 20231 min read
Singapore's HSA: Consultation on eCTD Implementation & Risk Classification on IVD
On 2nd May, 2023 Singapore's Health Sciences Authority (HSA) invited the industry to participate in the consultation on eCTD submissions...
Sharan Murugan
May 4, 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
USFDA Guidance on Providing Regulatory Submissions in Alternate Electronic Format
This updated guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a...
Sharan Murugan
Jun 26, 20221 min read
Providing Regulatory Submissions in Alternate Electronic Format – US FDA
The US Food and Drug Administration on 1st-July,2021 issued final guidance to assist sponsors in using alternate electronic formats for...
Sharan Murugan
Jul 5, 20211 min read