TGA expands MS-2 Step approval for abortion and miscarriage care
22 Oct 2026
MS-2 Step, which contains mifepristone and misoprostol, is now approved for medical abortion up to 70 days of pregnancy. This extends the previous limit by seven days. The medicine is also approved for managing missed miscarriage up to 70 days of pregnancy.
A missed miscarriage occurs when an embryo or foetus has died but the pregnancy tissue remains in the uterus. The TGA states that ultrasound is used to determine the stage of pregnancy for this indication.
The TGA reported no new safety concerns under either approval. The side effects were consistent with those already known for MS-2 Step.
Professor Danielle Mazza, Chair of General Practice at Monash University and a women's health expert, said the changes were significant for Australian women and GPs.
She said the changes align the approved uses of MS-2 Step with national clinical guidelines and could help GPs feel more confident prescribing the medicine.
Professor Mazza also highlighted the role of general practice in supporting women through contraception, pregnancy planning, unplanned pregnancies and miscarriage care.
For women seeking an abortion, the additional seven days may provide more time to access services. Professor Mazza noted that women facing greater disadvantages can struggle to reach an abortion provider before the previous nine-week limit.
The new approval for missed miscarriage also gives women another management option. Previously, choices included waiting for the pregnancy tissue to pass naturally or undergoing a surgical procedure. Medication now offers an additional option for eligible patients.
MS-2 Step became more widely accessible after TGA reforms in 2023. Before these changes, its prescribing was restricted to certified doctors.
Professor Mazza hopes the latest approvals will encourage more GPs to provide medical abortion and miscarriage care. She said the TGA's approval could help clinicians feel more confident using the medicines, particularly those who have not previously offered these services.
The TGA reviewed evidence supplied by the medicine's sponsor to support the new indications.
For medical abortion between 64 and 70 days of pregnancy, the TGA reported strong evidence of effectiveness. One large study found successful termination rates of 93.5% between 57 and 63 days and 92.8% between 64 and 70 days. Another study reported complete termination rates above 93.2% in the later gestational group.
The TGA said these findings showed that MS-2 Step remained effective during the extended period.
For missed miscarriage management up to 70 days, the regulator considered published research, clinical guidelines, real-world evidence and the medicine's established safety profile. An analysis combining several studies found that taking mifepristone followed by misoprostol was more effective at completing a miscarriage than waiting for it to occur naturally. This finding applied to missed miscarriage.
Although the new approvals are in effect, Pharmaceutical Benefits Scheme (PBS) subsidies have not yet been extended to cover the newly approved uses.
Professor Mazza said extending PBS subsidies to cover the new approved uses would be a reasonable next step.
GPs seeking further training and support can access the Australian Contraception and Abortion Primary Care Practitioner Support Network (AusCAPPS). The network plans to update its resources to reflect the extended medical abortion indication and the new missed miscarriage approval.
TGA expands MS-2 Step approval for abortion and miscarriage care
Source: Therapeutic Goods Administration (TGA) — MS-2 Step (mifepristone and misoprostol). Additional reporting based on the supplied newsGP article.