Can I sell before the stability study finishes?

Yes, with a shelf life backed by evidence held at listing. Older TGA guidance says the sponsor may set an interim or abbreviated shelf life, supported by evidence, until the stability results are available.

What is accelerated stability testing?

Testing above the label's maximum temperature, to predict a shelf life from short-term results. Older TGA guidance for listed complementary medicines calls it acceptable, but says full-term data at the nominated storage temperature should be collected.

How many batches need stability testing?

Older TGA guidance says "a minimum of two production batches should be used", with pilot-scale batches as an interim measure. Then at least one batch from each product group should go on the ongoing program each year.

What happens if a stability result fails?

TGA guidance calls for a formal investigation, a risk assessment where the shelf life could be compromised, and, where the shelf life can't be met, a reduced shelf life on later batches. Significant departures from the product's stability profile should be reported to the TGA, and if a medicine doesn't comply, the TGA may require the sponsor to update its label, remove it from the ARTG or recall it.

Do foods need stability testing?

Not under the TGA's guidance, and the Food Standards Code sets no stability protocol. But a best-before date is the date up to which the food stays fully marketable and keeps any qualities claimed for it, so the supplier, who is responsible for the date, needs a basis for it.

Listed medicines

Stability testing and shelf life for supplements: what the TGA expects

TGA guidance says a listed medicine's sponsor should hold, at or before listing, evidence that the product will meet its specifications, stored as its label says, until its expiry date. That evidence comes from stability studies. Stability testing is mandatory, and the ongoing program runs in real time at the label's storage conditions: at least one batch from each product group should go on the ongoing program each year. This guide covers what the TGA expects, real-time and accelerated studies, what is tested and how long it takes.

In short

TGA guidance says a listed medicine's sponsor should hold stability evidence at or before listing, showing the product meets its specifications, stored as its label says, until its expiry date.
If full data aren't ready, older TGA guidance allows an interim shelf life supported by evidence. Testing only at expiry isn't acceptable.
Ongoing stability testing is mandatory and runs in real time: at least one batch from each product group should go on the program each year.
A program lasts at least as long as the shelf life it supports. Our recent programs run for 24 or 36 months.

What the TGA expects

A listed medicine is not individually evaluated by the TGA before it is supplied. Instead, the sponsor certifies at listing that it holds the records needed to meet quality requirements, such as stability information (the whole process is in our TGA listing guide).

TGA guidance says those records, held at or before listing, should show that the medicine's specifications "will be maintained under the conditions set out on the medicine's label until the medicine's expiry date".

Where a standard applies, the medicine must conform to it. For tablets and capsules, that includes TGO 101, which TGA guidance says medicines must comply with "throughout their shelf-lives". Unless it follows a pharmacopoeial monograph, a listed tablet or capsule must assay at 90.0 to 120.0% of the amount on the label for most active ingredients. Vitamins, minerals, enzymes and probiotics have their own limits.

A listed medicine may be reviewed at any time while it is on the ARTG. "Initial stability reviews" were among the TGA's 2024–25 compliance focus topics.

Selling before the study finishes

If complete stability data aren't available at listing, older TGA guidance says the sponsor "may make a judgement on an interim or abbreviated shelf life". The judgement must be supported by evidence, and may be used until the stability results are available. Testing only at expiry, for example on a retention sample, is not acceptable.

Real-time and accelerated studies

Real-time studies store the product at its label's storage conditions, to at least the end of its shelf life. Accelerated studies store it above the label's maximum temperature, to predict a shelf life from short-term results.

Study	How it is run	What it can support
Real-time	At the storage conditions on the label	The full shelf life
Accelerated	Above the label's maximum temperature, for a shorter time	A predicted shelf life; full-term data should still be collected
Similar product	Existing studies on a similar product	Under older TGA guidance, a shelf life for a complex multi-ingredient product, if the sponsor holds evidence the data apply; the product's own data in its market pack should still be collected
Ongoing	In real time, on at least one batch per product group a year	Confirmation that the product remains stable over its shelf life

For listed therapeutic sunscreens, the TGA's 2025 guidance puts numbers on it. Six months at 10°C above the labelled storage temperature can predict a two-year shelf life, and nine months a three-year one. Where the shelf life at listing rests on pilot-scale batches and accelerated studies, the sponsor will need to confirm it. That takes real-time studies across the whole shelf life, on at least two production batches.

The ongoing program

Stability testing for listed and complementary medicines is mandatory. The sponsor must make sure there is stability data to support the shelf life, and have access to the laboratory results. The testing can be contracted out, with responsibilities defined in a GMP agreement.

Batches. Older TGA guidance asks for at least two production batches, or pilot-scale batches in the interim. Then at least one batch from each product group should go on the ongoing program each year.
Groups. Grouping needs a documented justification: similarly constructed formulations and the same dosage form, method of manufacture and primary packaging. Different dose forms or packs may need separate studies.
Time points. The initial study's protocol should be "in line with the ICH Guideline time points for stability testing". Once the initial studies are confirmed as acceptable, ongoing studies may use different time points. They should still run to at least the end of the shelf life.
Conditions. For example, a label that says "store below 30°C" means studies at 30 ± 2°C and 65 ± 5% relative humidity; "store below 25°C", 25 ± 2°C and 60 ± 5%; "store below 8°C (refrigerate)", 5 ± 2°C. The study must also meet the requirements of each country the product is sold into.
Tests. Physical tests, including pack integrity; each active ingredient claimed on the label, tested quantitatively throughout the study by validated stability-indicating methods; and microbiological tests at least at the start and end. Reduced ongoing testing may be acceptable with a documented risk assessment, where full data already support the shelf life. Organic-form minerals are tested at least at the start and end, and chromatographic profiling should be considered for herbal ingredients with no standardised component claimed.
Changes. A product change calls for a risk assessment of whether a new stability study is needed.

When a result fails

Results are reviewed at each time point. TGA guidance says an out-of-specification result or an atypical trend needs a formal investigation, and a risk assessment where the shelf life could be compromised. Where the shelf life can't be met, later production batches are to carry a reduced shelf life that reflects what is achievable. Reports should be available to the person who releases batches for supply, the sponsor, and the TGA on request.

The TGA doesn't only hear on request. Its 2020 guidance on the GMP code, written for an earlier edition of the code, says the TGA must be told of all statistically significant departures from established stability profiles, and that the GMP agreement between sponsor and manufacturer should say who reviews stability data and reports issues.

In its desktop stability reviews, the TGA said a sponsor would be given a chance to address deficiencies, and that enforcement action, such as cancellation from the ARTG, may also be taken. When a medicine doesn't comply, the TGA acts on the risk: it may require the sponsor to update its label, remove it from the ARTG or recall it.

How long it takes

Since the ongoing protocol should extend to at least the end of the shelf-life period, a program lasts at least as long as the shelf life it supports. From our records:

24-month stability programs on EverLeanBody's saffron capsule and a halal-certified eye-health formula
a 36-month stability program on The Belly Solution's travel gut-health powder
formula and evidence work on two supplements and a sunscreen for an international skincare brand, with stability studies out to 36 months
the stability protocol needed to support a three-year expiry on an eye-health tablet
a long-term stability program on a complex herbal capsule

Foods and cosmetics

The TGA's ongoing-stability guidance applies only to listed and complementary medicines. Foods are date marked under Standard 1.2.5 of the Food Standards Code instead, and the food supplier is responsible for the date. Most foods have a best-before date; a use-by date is for foods that must be eaten by a certain time for health or safety reasons. Except for infant formula, no date mark is needed if the best-before date is two years or more after it is determined. More on the food pathway.

An SPF moisturiser stays a cosmetic only if, among other conditions, it carries an expiry date when it isn't stable for at least 36 months. More on skincare.

Where we come in

We design the stability protocol for the shelf life the label will carry, and manage the program. We also design the formula, build the claims evidence, secure the listing and draft the label. More on the listed-medicines pathway, or book a call.

Questions

: At least as long as the shelf life it supports: the TGA says the ongoing protocol should extend to at least the end of the shelf-life period. Our records include 24-month and 36-month programs.
: Yes, with a shelf life backed by evidence held at listing. Older TGA guidance says the sponsor may set an interim or abbreviated shelf life, supported by evidence, until the stability results are available.
: Testing above the label's maximum temperature, to predict a shelf life from short-term results. Older TGA guidance for listed complementary medicines calls it acceptable, but says full-term data at the nominated storage temperature should be collected.
: Older TGA guidance says "a minimum of two production batches should be used", with pilot-scale batches as an interim measure. Then at least one batch from each product group should go on the ongoing program each year.
: TGA guidance calls for a formal investigation, a risk assessment where the shelf life could be compromised, and, where the shelf life can't be met, a reduced shelf life on later batches. Significant departures from the product's stability profile should be reported to the TGA, and if a medicine doesn't comply, the TGA may require the sponsor to update its label, remove it from the ARTG or recall it.
: Not under the TGA's guidance, and the Food Standards Code sets no stability protocol. But a best-before date is the date up to which the food stays fully marketable and keeps any qualities claimed for it, so the supplier, who is responsible for the date, needs a basis for it.