The TGA is seeking feedback on a proposal to publish the names of excipient ingredients used in therapeutic goods in the public view of the Australian Register for Therapeutic Goods (ARTG).
TGA is responding to consumer frustrations that they cannot easily access this information through existing mechanisms. By making this information available in the public ARTG view, which is available on the TGA website, it hopes to help consumers make more informed and safer choices about their medicines.
To make safe and informed choices, people need access to information about the ingredients in their therapeutic goods. It is also important to have this information to identify when specific ingredients may have contributed to an adverse reaction.
Some information about the ingredients in therapeutic goods is available to consumers in public documents. Alternatively, consumers must contact the company responsible for the goods or make a request for specific ingredient information from the TGA. Consumers have expressed frustrations that these mechanisms do not provide easy access to information about excipient (or ‘inactive’) ingredients in all medicines.
In response, TGA is consulting on options for making this information available online in the public summaries of goods on the ARTG.
- Consultation: Increased access to ingredient information online (pdf,269kb)
- Consultation: Increased access to ingredient information online (docx,565kb)
Content of submissions
Submissions may address any, or all, of the questions posed in the consultation paper.
TGA is specifically interested in what impact (health, safety or commercial) displaying the names of excipient ingredients would have on you. If the proposals in the paper are implemented, TGA is also interested to know if any organisations are willing to collaborate to help raise consumer awareness about the availability of this information.
How to submit
Complete the online consultation submission form to upload your submission in either pdf or word format.
Alternatively, hardcopy submissions with a printed cover sheet may be mailed to:
ARTG excipients project
Scientific Operations Management Section
Scientific Evaluation Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Any questions relating to submissions should be directed to ARTG.firstname.lastname@example.org
FOR MORE INFORMATION visit https://www.tga.gov.au/consultation/consultation-increased-online-access-ingredient-information