The Therapeutic Goods Administration (TGA) has published a consultation paper seeking feedback on whether it should make excipient ingredients publically available on the Australian Register of Therapeutic Goods (ARTG). If implemented, excipient ingredient names would be published in ARTG public summaries for prescription medicines, biologicals (cell and tissue therapies), non-prescription medicines (registered and listed, including complementary medicines), and other therapeutic goods (i.e. disinfectants and sterilants).
At present, the names of excipient ingredients are only visible in the TGA's internal view of the ARTG. Due to the increasing consumer use of online sources for health information, the TGA considers that publishing excipient ingredients would provide an opportunity to better inform consumers and support the safe use of therapeutic goods.
The Consultation Paper proposes three alternative options:
1. Publish the names of excipients in ARTG public summaries for therapeutic goods, except for those ingredients used in flavour or fragrance proprietary ingredient mixes.
Under this option, flavour and fragrance proprietary ingredient mixes would be displayed by either their proprietary name and number, or by their purpose, and would not display their constituent ingredients. This approach would be consistent with ingredient information for foods and cosmetics in Australia, and with the practices adopted in New Zealand and Canada for both prescription and non-prescription medicines.
2. Publish the names of excipients in ARTG public summaries for therapeutic goods, except for those ingredients used in any type of proprietary ingredient mixes.
The Consultation Paper notes that there are currently 16 types of proprietary ingredients used in therapeutic goods (including colours, printing inks, preservative mixes, coating solutions, capsule formulations, flavours, fragrances, and cream bases). This option would mean any combination of ingredients referred to as a proprietary ingredient mix would be included in the ARTG public summary by either its proprietary name or by its purpose. The TGA considers that this approach would provide increased consumer access to excipient information in therapeutic goods, but would still leave significant gaps in publicly available information, and would result in a misalignment with the Australian approach to foods and cosmetics.
3. Status quo - the TGA would not publish excipient names.
Businesses could voluntarily publish formulation information, but the TGA would take no action to publish excipient ingredients in ARTG public summaries.
The TGA is accepting feedback on the Consultation Paper until 10 October 2019, including in relation to the risks and benefits (i.e. commercial, consumer safety, and innovation) for each of the proposed options.
The TGA Consultation Paper can be found here.
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