Resources
Search our resources for user guides, checklists, international scientific guidelines, compositional guidelines and forms.
Can't find what you’re looking for? You can also:
- search our Publications
- use the site search bar in the top right of this screen for more results.
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
Topic
- Safety monitoring and information (51)
- Clinical trials (44)
- Legislation (24)
- Manufacturing (23)
- Import and export (10)
- Compliance and enforcement (7)
- Advertising (4)
- Labelling and packaging (4)
- Medicinal cannabis hub (4)
- Shortages and supply disruptions (3)
- Vaping hub (3)
- Committees and advisory bodies (2)
- Fees and payments (2)
- Scheduling (national classification system) (2)
- Unique Device Identification (UDI) hub (1)
Search
629 result(s) found, displaying 26 to 50
-
User guideSponsor user guide updated to include final report and additional information requirements following amendments to the Therapeutic Goods (Medical Devices) Regulations 2002.
-
FormsThis form is used by sponsors of exempt therapeutic goods to inform the TGA of the details of the supply of such goods on a quarterly basis, as required by item 5 of Schedule 5A to the Therapeutic Goods Regulations 1990.
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/PRAC/222346/2014
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH E6 (R2) Integrated Addendum
-
-
FormsCTA applications are submitted using paper-based forms. There are two forms that must be completed by the sponsor.
-
FormsThis form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.
-
FormsA revised CPD template for Biological medicines and vaccines is now available for sponsors
-
-
User guideThis user guide is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device.
-
User guideUser guide on how to submit shortage/discontinuation notifications to the TGA
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/426390/2021
-
FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N2 application
-
User guideHow to successfully complete and submit an application for consent to import, supply, or export medical devices that do not meet the Essential Principles.
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/VWP/457259/2014
-
FormsCertified product details (CPD) - Chemical prescription medicines
-
User guideThis user guide is for sponsors applying to change the entry in the ARTG for a registered non-prescription OTC medicine.
-
FormsUse these forms to request a meeting and to record agenda items and outcomes.
-
User guideThis document is for Australian sponsors and manufacturers of sterile medicines and active pharmaceutical ingredients (APIs) made or supplied in Australia.
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/ICH/449035/2009
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CAT/80183/2014
-
User guideA guide for using the TGA Business services (TBS) portal for listed and assessed listed medicine applications.
-
User guideCheck out our user guide to assist sponsors when using the code tables for GMP Clearance applications.
-
User guideA step-by-step guide for Australian manufacturers of therapeutic goods.
-