Calls for proprietary ingredient mixes, such as flavours or fragrances Australian Register of Therapeutic Goods (ARTG) to be made known.
The TGA are making more hidden medicine ingredients, known as ‘inactive ingredients’ to be shown online. More from Jolanta Samoc, Project Manager from Scientific Operations Management, Scientific Evaluation Branch, Therapeutic Goods Administration, Department of Health:
Good afternoon
We are writing to you because you responded to our survey about making more medicine ingredient information available online and asked to receive updates about outcomes.
What we asked
In the survey, we asked for your views on options for displaying the names of inactive ingredients (also known as ‘excipients’) on the online Australian Register of Therapeutic Goods (ARTG), on the TGA website. Thank you to everyone who responded for your valuable feedback.
What we heard
Most people who responded to our consumer survey wanted greater transparency of medicine formulations. Many called for all ingredient information to be displayed on the ARTG, including details of proprietary ingredient mixes, such as flavours or fragrances. Many also wanted to have all ingredients in a formulation declared on a medicine’s labels.
What we are doing
We have now published the outcomes of our consultation on this proposal. This includes:
- all submissions and de-identified survey responses, where the respondents gave us permission for their publication, and
- a statement about the changes that will be made.
The TGA website will be changed to display the names of excipient ingredients in medicine summaries on the ARTG. Where these ingredients are present in a flavour, fragrance or colour proprietary ingredient mix, the mix will be identified using the terms ‘flavour’, ‘fragrance’ and ‘colour’ in the ARTG entry.
We are not proposing to change medicine labels at this time. Medicine labelling requirements were updated in 2016 after extensive consultation and with a focus on improving safe use of medicines. Australian medicine labels must identify any common allergens present in the medicine, such as lactose or peanut products. The list of allergens that must be declared was expanded in 2016. These substances have to be stated on the label, even when they are present in a flavour, fragrance or colour mix. The medicine label is still the best source of information for people who need to know about common allergens.
When
Before excipient ingredient names can be included in ARTG summaries, we need to create the legislative basis for the publication. This will be a new legislative specification under subsection 61(5D) of the Therapeutic Goods Act 1989 and it will be published on the TGA website when finalised.
We will also need to change our IT systems. We expect these changes to be implemented in the first half of 2020 and will make an announcement on the TGA website at that time.
If you have any questions about this matter please contact us at ARTG.excipients@tga.gov.au.
Jola
Jolanta Samoc
Project Manager
Scientific Operations Management
Scientific Evaluation Branch
Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606 Australia
www.tga.gov.au
Your thoughts?