Australia's Therapeutic Goods Administration (TGA) is set to announce emergency regulatory measures on Wednesday to address critical shortages of hormone replacement therapy patches that have left thousands of menopausal women unable to access prescribed medication, sources familiar with the agency's deliberations confirmed.
The shortages, which have seen women cutting patches in half and travelling interstate to find supplies, have persisted for several months. Reports emerging this week indicate that supplies of some HRT patch formulations may not return to normal levels until at least the end of 2026, prompting the TGA to consider expedited parallel import approvals for equivalent estradiol patch products approved in the United Kingdom and European Union markets.
The TGA is expected to issue a formal shortage notification update and announce a mechanism allowing pharmacies to source Novartis and Besins Healthcare estradiol patch products from approved overseas markets on a temporary basis. The Australasian Menopause Society has been in active discussions with the TGA since late April, urging the regulator to act before winter months when patients and GPs face additional pressure on appointments.
Women's health advocates and the Royal Australian College of General Practitioners have both called for immediate action, noting that interrupted HRT therapy can carry significant health consequences, including increased risk of osteoporosis and cardiovascular events over the long term. Several GP networks in New South Wales and Victoria have begun issuing guidance to patients on alternative formulations, including gels and oral preparations, as a temporary measure.
Pharmacy Guild of Australia representatives are expected to participate in a briefing following the TGA announcement, outlining distribution protocols for any parallel-imported stock. Health Minister Mark Butler's office confirmed that ministerial attention has been directed to the shortage and that a formal statement on the government's response is anticipated Wednesday morning.