Supply an unapproved therapeutic good (sponsors) From Therapeutic Goods Administration (TGA) 🇦🇺 Find out the requirements to supply unapproved therapeutic goods in Australia, including through the Special Access Scheme or Authorised Prescriber scheme. 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 August 13, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 rapid antigen self-tests that are approved in Australia From Therapeutic Goods Administration (TGA) 🇦🇺 A list of approved COVID-19 tests included in the ARTG for supply in Australia. 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 13, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Disinfectants, sterilants and sanitary products From Therapeutic Goods Administration (TGA) 🇦🇺 How sterilants and disinfectants are regulated in Australia. List of relevant legislation. 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 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Principle 2: Design and construction of medical devices to conform with safety principles From Therapeutic Goods Administration (TGA) 🇦🇺 Manufacturers of medical devices must hold evidence that demonstrates that their devices meet the Principles before their devices can be supplied in Australia. 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 August 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
MMDR program achievements From Therapeutic Goods Administration (TGA) 🇦🇺 We have delivered a raft of reforms, in addition to maintaining core business activities that ensure the high quality regulation of therapeutic goods in Australia. 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 August 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
How we are managing medical device supply disruptions resulting from changes in Europe From Therapeutic Goods Administration (TGA) 🇦🇺 We are managing the impact of the European Union Medical Devices Regulation (EU MDR) transition in Australia. 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 August 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the content, management and archiving of the clinical master file (paper and/or electronic) From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/INS/GCP/856758/2018 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 31, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Steps to supply for device sponsors From Therapeutic Goods Administration (TGA) 🇦🇺 A step-by-step process for sponsors (official suppliers) to supply medical devices in, or export them from, Australia. 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 July 31, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Steps to supply for device manufacturers From Therapeutic Goods Administration (TGA) 🇦🇺 Step-by-step process for manufacturers to supply devices in, or export them from, Australia. 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 31, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Changes to the regulation of vapes From Therapeutic Goods Administration (TGA) 🇦🇺 Find out about changes to the regulation of all vapes in Australia. 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Possession and supply of vaping goods in Australia From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance provides an overview of who may possess (and in some instances, also supply) specified vapes, under the Possession and Supply Determination. 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 July 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CHMP/EWP/89249/2004 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/CHMP/BPWP/144533/2009 rev 1) 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of Plasma derived Fibrin Sealant/Haemostatic Products From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CPMP/BPWG/1089/00 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of human plasma derived von Willebrand factor products From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CPMP/BPWG/220/02 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CHMP/BPWP/410415/2011 Rev 1 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/CHMP/BPWP/94033/2007 rev. 2 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on the Clinical Investigation of Human Anti-D Immunoglobulin for Intravenous and/or Intramuscular Use From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CPMP/BPWG/575/99 Rev. 1 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/CHMP/BWP/187338/2014 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on process validation for finished products - information and data to be provided in regulatory submissions From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites