Regulatory Blog

Health Canada has released detailed guidances addressing the validation rules for regulatory transactions submitted in two formats: "...

The South African Health Products Regulatory Authority (SAHPRA) has released a communication " Implementation of RIMS – Information on...

The Therapeutic Goods Administration (TGA) of Australia has released the latest version, v3.2, (on 13 September 2024) of the eCTD AU...

This Friday (13 Septmeber, 2024) the USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...

The South African Health Products Regulatory Authority (SAHPRA) has provided updated guidance for " ECTD Validation And Technical...

Health Canada recently (13 May 2024) updated its guidance "Preparation of Regulatory Activities in Non-eCTD Format" (electronic Common...

Swissmedic, recently published updated guidance on "Guidance Industry eCTD" and "Guidance on Time limits for Authorisation Applications"....

Australia's Therapeutic Goods Administration (TGA) released updated guidance "eCTD AU module 1 and regional information" on 30 January...

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

Health Canada recently published an updated guidance on "Validation rules for regulatory transactions provided to Health Canada in the...

Recently (7th Spetember, 2023) Australia's Therapeutic Goods Administration (TGA) released revised and updated guidance "Submitting data...

Health Canada recently (09 June, 2023) published an updated guidance on "Preparation of Regulatory Activities in Non-eCTD Format" that...

Recently (18 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Application form template...

Recently (05 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released the template "Validation Template For...

On 2nd May, 2023 Singapore's Health Sciences Authority (HSA) invited the industry to participate in the consultation on eCTD submissions...

Recently USFDA released an updated "Electronic Common Technical Document (eCTD) Technical Conformance Guide" that revised some sections...

This updated guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a...

The US Food and Drug Administration on 1st-July,2021 issued final guidance to assist sponsors in using alternate electronic formats for...

eCTD and NeeS are the standard electronic submission formats and allow the Common Technical Document (CTD) structure to be provided in an...

This guidance and the technical specifications document it incorporates by reference describe the requirements for electronic submission...