Resources
Search our resources for guidance, 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
- Prescription medicines (231)
- Complementary medicines (130)
- Therapeutic goods regulation (96)
- Listed medicines (93)
- Non-prescription medicines (77)
- Over the counter (OTC) medicines (76)
- Manufacturing (56)
- Biological medicines (50)
- In Vitro Diagnostic medical devices (IVDs) (40)
- Assessed listed medicines (28)
- Regulatory compliance (26)
- Medical devices safety (25)
- Medicines safety (24)
- Safety (23)
- Registered complementary medicines (22)
- Advertising (21)
- Labelling and packaging (20)
- Scheduling (national classification system) (16)
- Australian Register of Therapeutic Goods (ARTG) (15)
- Import and export (15)
- Legislation (15)
- Clinical trials (14)
- Medicinal cannabis hub (14)
- Shortages (9)
- Disinfectants/Sterilants (8)
- COVID-19 (6)
- Vaping hub (6)
- Advisory bodies and committees (5)
- Blood and blood components (5)
- Electronic submissions (5)
- Fees and payments (5)
- Pharmacovigilance (5)
- Sunscreens (5)
- TGA conformity assessment certification (4)
- Alert/Advisory (3)
- Metal-on-metal hip replacement implants hub (3)
- Artificial Intelligence (AI) (2)
- COVID-19 vaccines (2)
- Blood safety (1)
- Implantable medical devices (1)
- Personalised medical devices (1)
- Prescription opioids hub (1)
- Software as a medical device (1)
Results for
"[search-keyword]"
Search
1019 result(s) found, displaying 1 to 25
-
User guideThe Special Access Scheme (SAS) & Authorised Prescriber (AP) scheme Online System (SAS & AP online system) is the preferred method of submission for SAS applications and notifications.
-
Reference materialFind out more about product standards that apply to unapproved therapeutic vapes for smoking cessation and the management of nicotine dependence.
-
Compositional guidelinesCompositional guideline for Akkermansia muciniphila strain ATCC BAA-835 permitted for use in listed medicines.
-
User guideThis document applies to all regulatory activities in electronic Common Technical Document (eCTD) format.
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/QWP/608924/2014
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH M3 (R2 ) Q&As; EMA/CHMP/ICH/507008/2011
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH M2(R2); EMA/CPMP/ICH/286/1995
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/ICH/607698/2008
-
FormsCTA applications are submitted using paper-based forms. There are two forms that must be completed by the sponsor.
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/360642/2010 rev. 1
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BWP/298388/05
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BWP/298390/2005
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BWP/398498/2005
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/CPWP/83508/2009
-
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 – ICH E12; CPMP/ICH/541/00
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH E14; EMA/CHMP/ICH/310133/2008
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E2C (R2); EMA/CHMP/ICH/544553/1998
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E3 Q&As (R1); EMA/CHMP/ICH/435606/2012
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH E8 (R1); EMA/CHMP/ICH/544570/1998 Corr*
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E3; CPMP/ICH/137/95
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/814397/2011
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/429241/2013
-
User guideHow to withdraw your ARTG application, for medical device sponsors (includes importers and exporters).
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BWP/452081/2007