You are here

Submissions received and TGA response: Increased online access to ingredient information

23 January 2020

Between 29 August and 10 October 2019, we sought feedback from interested parties on a proposal to increase access to ingredient information. We proposed to publish the names of excipient (or 'inactive') ingredients in the public view of therapeutic goods on the Australian Register for Therapeutic Goods (ARTG).

This consultation was responding to consumers' frustrations that they cannot easily access this information through existing mechanisms. By making this information available in the public view of ARTG entries, which are available on the TGA website, we hope to help consumers make more informed choices about their medicines.

For this consultation we trialed a new way for people to provide us with their input. Consumers could choose to share their views through either the standard submission process or a quick consumer survey.

We received:

  • 39 standard submissions from therapeutic goods companies and industry bodies, government organisations, consumer and health professional groups and individuals.
  • 402 responses to the consumer survey.

Thank you to everyone who responded for your valuable feedback.

All submissions and survey responses that were not marked as confidential are available in the links below.

Submissions received

A B C D H M N P S T V W

How to access a pdf document

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open it from there.

A

B

C

D

H

M

N

P

S

T

V

W

  • Consultation submission: Whiteley Corporation

Survey responses received

Of the 402 survey responses received, 311 respondents gave permission to publish their responses (pdf,627kb)*.

TGA response

In their feedback, consumers and health professionals confirmed that the Australian community wants greater transparency of medicine formulations. Many called for all ingredient information to be published, including details of proprietary ingredients such as flavours and fragrances. Although it was not proposed in the consultation, there was a preference for all ingredients to be stated on medicine labels. Some consumers highlighted the absence of this information for Australian medicines, particularly compared to medicines available overseas.

Many of the industry responses confirmed that releasing the names, but not quantities, of excipient ingredients and most mixes would not affect commercial confidentiality. They confirmed the importance of keeping the trade names of flavour, fragrance and colour mixes confidential.

After considering the issues raised in the consultation, it is proposed to:

  • display excipient names in the public view of ARTG entries for medicines, where these ingredients are not present in a flavour, fragrance or colour proprietary ingredient mix
  • identify flavour, fragrance and colour proprietary ingredient mixes using the generic terms 'flavour', 'fragrance' and 'colour' and
  • apply this approach to all medicines and biologicals, but not extend it to Other Therapeutic Goods (OTGs), such as disinfectants.

The changes are a compromise for consumers who seek full formulation details on all goods. We are not proposing to change medicines labels at this time. Updating medicine labels can be costly and labelling requirements were recently changed to help improve safe use of medicines.

In their feedback, many consumers raised concerns about allergy declarations. Australian medicine labels are already required to identify common allergens, such as lactose or peanut products. These substances have to be declared 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 consumers who need to know about common allergens. The public ARTG summaries will not include information about allergen substances in flavours, fragrances, colours or where they are used as manufacturing aids. This information will instead be on the label.

Next steps

Before we can publish excipient ingredient names, 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 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.

No action is needed from sponsors to make this information public.

For further information please contact ARTG.Excipients@tga.gov.au.