TGA expands MS-2 Step: missed miscarriage and 70-day limit

If you have been told you have a missed miscarriage — where the embryo has stopped developing but your body has not yet passed it — there is a formal change to the medication options available to you in Australia that took effect this week.

The Therapeutic Goods Administration has approved two significant changes to MS-2 Step (the combination of mifepristone and misoprostol): a new formal indication for the medical management of missed miscarriage, and an extension of the approved gestational limit for pregnancy termination from 63 to 70 days.

Both of these matter. And they matter in slightly different ways.

What just changed

Missed miscarriage is a diagnosis that comes with a particular kind of loss — you find out at an ultrasound, often at a routine appointment, that the pregnancy stopped some time ago. Your body hasn’t caught up. You have three options: wait for the miscarriage to pass naturally (which can take weeks), take medication to bring it on, or have a surgical procedure.

Until now, MS-2 Step was not formally approved for missed miscarriage. Some GPs were using it off-label — and the evidence base was there to support that — but they were doing so without formal TGA backing. That gap has now closed.

Professor Danielle Mazza, Monash University’s Chair of General Practice, called the approval “highly significant” and described it as giving women “another option to take the medication and move forward with the resolution of the miscarriage.” Women who previously had only expectant management or surgery now have a medication option that is formally endorsed.

The evidence behind this approval found that mifepristone followed by misoprostol achieved complete miscarriage more often than waiting for natural completion. The TGA’s analysis found the benefit applied specifically to missed miscarriage (not other miscarriage types), and gestational age is confirmed by ultrasound.

The gestational limit extension is a separate change. Medical termination of pregnancy with MS-2 Step was previously approved up to 63 days’ gestation (nine weeks). It is now approved to 70 days — a one-week extension. The TGA reviewed evidence showing 92.8% complete termination at 64–70 days, compared with 93.5% at 57–63 days. The safety profile was consistent with what was already known.

Both-and: what this does and doesn’t resolve

Here is what is straightforwardly positive: GPs who were already managing missed miscarriage with this combination can now do so with formal approval rather than off-label risk. For patients, it means medication is an explicit, supported option rather than one that depends on finding a GP willing to prescribe outside label. That is a real reduction in barrier.

And the gestational limit extension matters for anyone presenting slightly later than 63 days — a situation that is more common than it might seem, given that dating scans are not always available immediately, and that rural and regional patients may have longer waits between GP visit and ultrasound confirmation.

What it doesn’t resolve is cost. PBS subsidy has not been extended to these new uses. Mifepristone under MS-2 Step is PBS-subsidised for approved pregnancy termination up to 63 days — but the new missed miscarriage indication, and the 64–70 day window, sit outside PBS coverage for now. Patients accessing these services may face out-of-pocket costs until PBS listing is sought and granted. Professor Mazza flagged this explicitly: the TGA approval is the clinical green light; PBS access is a separate, still-pending step.

2 cents: what this means for your terrain this week

If you are currently experiencing a missed miscarriage and want to understand your options, a conversation with your GP is the starting point. The medication option is now formally available, and your GP can advise on whether it is appropriate for your specific situation — gestational age, any relevant history, and what the process would involve.

If you are seeking pregnancy termination and your gestational age is between 64 and 70 days: the formal approval now covers this range. Access varies by state and practice, and not all GPs provide this service, so a direct conversation with your usual GP about what they offer — or a referral to a GP who does — is the practical next step.

For anyone supporting someone through a missed miscarriage: the question “what are my options?” is now a question with a clearer answer. Expectant management, medication, and surgery are all formally available. That choice belongs to the person experiencing the loss, made with their GP and with access to complete information.

It is worth knowing that the TGA approval process is where the evidence gate sits. This approval signals that the evidence base is solid enough to move this from off-label into formal indication. That matters for clinical confidence on both sides of the consultation.

Verdict: yes — this is worth knowing about.

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Sources cited

1. MS-2 Step gets TGA green light for missed miscarriage — newsGP, Oct 2026
2. ‘Highly significant’ changes for MS-2 Step use approved by TGA — Medical Republic, 22 Oct 2026