International Recognition Procedure From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to use the procedure for medicines licensing applications. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 29, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
ICH Electronic Common Technical Document (eCTD) v4.0 From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - ICH M8 Expert Working Group Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
eCTD AU module 1 and regional information From Therapeutic Goods Administration (TGA) 🇦🇺 This document replaces AU eCTD specification - Module 1 and regional information Version 3.0 and contains updated information. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 30, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submitting data in the eCTD format From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance on how to submit data in the electronic Common Technical Document (eCTD) format. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 7, 2023 Other (Non-Commercial) 0 reuses 0 favorites
eCTD withdrawals From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance for sponsors who need to withdraw information from their eCTD dossiers and can be used as best practice for NeeS withdrawals Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on November 30, 2020 Other (Non-Commercial) 0 reuses 0 favorites
eCTD baseline sequences From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance for sponsors converting their dossier format from paper, CTD or NeeS to eCTD Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on November 30, 2020 Other (Non-Commercial) 0 reuses 0 favorites
NeeS AU module 1 and regional information From Therapeutic Goods Administration (TGA) 🇦🇺 The NeeS specification is an interim arrangement as applicants plan the move to full eCTD Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on October 18, 2017 Other (Non-Commercial) 0 reuses 0 favorites
Australian eCTD submissions: Frequently asked questions From Therapeutic Goods Administration (TGA) 🇦🇺 Updated questions and answers Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 19, 2016 Other (Non-Commercial) 0 reuses 0 favorites
