How to Use the TGA Approval Database
1. The database covers all new chemical and new biologic entities (NCE/NBE) approved by the TGA from January 1, 2005 to May 7, 2024.
2. The information in the database comes from a variety of organisational databases and the contents of those databases cannot be independently verified:
a. ARTG: https://www.tga.gov.au/resources/artg
b. AusPAR: https://www.tga.gov.au/resources/auspar?keywords=
c. Haute Autorite de Sante: https://www.has-sante.fr
d. IQWiG: https://www.iqwig.de/en/
e. PMPRB: https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports.html (therapeutic ratings are near the back of the annual reports)
f. Prescrire International: https://english.prescrire.org/en/Summary.aspx (subscription required)
g. TGA: https://www.tga.gov.au/resources/publication/publications/prescription-medicines-and-biologicals-annual-summaries; https://www.tga.gov.au/resources/prescription-medicines-registrations
h. WHO ATC/DDD Index: https://atcddd.fhi.no/atc_ddd_index/
i. PBS: https://www.pbs.gov.au/pbs/home 
3. For NCE/NBEs approved after December 31, 2013, the TGA approval date comes from the TGA website. For NCE/NBEs approved on or before December 31, 2013 the date comes from the AusPAR report. Similarly, orphan drug status after December 31, 2013 comes from the TGA website and on or before December 31, 2013 comes from the AusPAR report. The name of drugs approved and date of approval between January 1, 2005 and December 31, 2009 comes from a Freedom of Information request made to the TGA.
4. There is no information about orphan drug status from January 1, 2005 to November 29, 2009.
5. The information in the database was gathered by one person (Joel Lexchin or Ashleigh Hooimeyer) and there maybe errors. Users are advised to consult the relevant web pages directly to verify the information. If you find any errors, please email me (jlexchin@yorku.ca) and I will correct them. The type of outcome (surrogate or clinical) in the pivotal trials comes from the AusPAR reports and the wording at times is unclear.
6. Prescrire International, the Haute Autorite de Sante and IQWiG periodically update their therapeutic assessments so the assessment from these organisations recorded in the database may be out-of-date.
7. It is unlikely that there will be any further therapeutic ratings from the PMPRB after December 31, 2022.
8. The therapeutic rating is agnostic to the indication. If there is more than one indication for the drug and different therapeutic ratings for the indications then the highest rating is used.
9. PBS listing is specific to indication and brand, therefore there are some generic/biosimilar products where a different brand of the product is listed. Likewise, the product may be listed for a different indication.
10. Sometimes there are two rows for a drug. In those cases, the same drug was approved for two separate indications.
11. The database is free to use but please cite it when it is used.  This citation should be used: Lexchin J, Hooimeyer A. New chemical and biological entities approved by the Therapeutic Goods Administration, January 1, 2005 to May 7, 2024. [Date accessed]. [URL for database- TBD once posted]