How long does it take to develop a supplement?

In short

• From our records, listed medicines have taken 32 days to 12 weeks from design to production order, and 5.8 to about eight months from brief or formulation to dispatch.
• The stages are the brief and the pathway, the formula, the evidence, stability, the label and the listing, then manufacturing and delivery. Most of them can overlap.
• The TGA's listing step is short. What holds a launch up is a formula that won't run, an ingredient that isn't on the TGA's list, or a pathway settled late.
• A new ingredient needs its own TGA evaluation first: the law allows 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation.

From our records

How long a product takes depends on where the clock starts. "Design to production order" runs from the start of design to the first production order. "Brief to dispatch" runs from the signed brief to the first batch leaving for the brand's 3PL, so it takes in manufacturing. One record starts at formulation instead.

Product	Pathway	Time	Measured from and to
A complex herbal capsule built around KSM-66® ashwagandha, with an evidence package covering more than 13 ingredients	Listed medicine	32 days	Design to production order
An eye-health formula, certified halal, in a 60-count pack and a 7-day trial pack	Listed medicine	Under seven weeks	Design to production order
A two-a-day probiotic skin supplement, the second version of its formula	Listed medicine	12 weeks	Design to production order
EverLeanBody's saffron capsule, built around affron®	Listed medicine	5.8 months	Signed brief to dispatch to the brand's 3PL
The Belly Solution's travel gut-health powder, in a 14-day pouch	Listed medicine	About eight months	Formulation to dispatch

Where the time goes

These are the stages a listed medicine is built in. Most of them can overlap: we run formulation, regulatory work and sourcing in parallel rather than in sequence.

1. The brief and the pathway. The customer, the claim, the format and the retail price come first, then the pathway: medicine, food or cosmetic. The pathway decides the ingredients you can use, the claims you can make, the label and who regulates you, so it is settled before the formula.
2. The formula. Every ingredient, its form and its dose, chosen for the claim and the price the product has to sell at, then samples and a specification a manufacturer can quote. For a listed medicine, every ingredient must already be in the TGA's Permissible Ingredients Determination, and be used within the limits it sets.
3. The evidence. Every indication must come from the TGA's permitted list, and the sponsor must hold evidence for each one. The herbal capsule above needed an evidence package covering more than 13 ingredients. More in our claims and indications guide.
4. Stability. The TGA says stability evidence should be held at or before listing. If full data aren't ready, older TGA guidance allows an interim shelf life supported by evidence, and real-time testing continues after launch. Our recent stability programs run for 24 or 36 months. More in our stability testing guide.
5. The label and the listing. The label is written to the TGA's labelling rules, now TGO 116. The listing is lodged and validated in TGA Business Services, the fee is paid within 14 days of submitting, and the medicine is then entered on the ARTG with its AUST L number.
6. Manufacturing and delivery. A cGMP partner matched to the format, the volume and the margin makes the first batch. It is release-tested, imported if it was made overseas, and delivered to the brand's warehouse or 3PL. Unless a step is exempt, every manufacturing step in Australia needs a TGA manufacturing licence, and an overseas site needs a TGA GMP clearance or certification.

What holds a launch up

• A formula that won't run. Another eye-health formula, for a different brand, kept failing in encapsulation because the ingredient mix was too wet, and hand-filling would have added one to two more months. We moved it to a direct-compression tablet, and it shipped in June 2024.
• An ingredient that isn't on the list. A new ingredient needs its own TGA application and evaluation before any product using it can be listed. The law allows the TGA 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation, depending on the application's level (IN1 to IN4). For 2026–27 the TGA charges $1,370 to apply and $18,456 to evaluate an IN1 or IN2 application, and $3,629 and $30,067 for IN3 or IN4.
• A pathway settled late. A product's pathway turns mostly on how it is presented: its claims, its name, its form, its dose. A claim added after the formula is set can move a product from food to medicine, and with it the ingredients, the label and the regulator.
• A factory without the right clearance. A listed medicine made overseas needs a TGA GMP clearance for the site, which the Australian sponsor applies for. A partner whose site already has the GMP evidence the TGA accepts makes that step shorter; it doesn't remove it.

The TGA's listing step is short

The TGA doesn't individually evaluate a listed medicine before it goes on the ARTG: the sponsor certifies that it meets the rules. Once the application passes validation and the fee is paid, the medicine is entered on the ARTG with its AUST L number, and it usually shows in TGA Business Services the next day.

So the listing itself rarely sets the pace; the work before it does. The TGA sets no timeframe for the sponsor's own work, only for evaluating a new ingredient where one is needed. More on the ARTG and the listing steps.

Foods and cosmetics

A product on the food pathway isn't entered on the ARTG: it must comply with the Food Standards Code. A cosmetic needs no TGA entry either, but the business that imports it or its ingredients, or makes the chemicals in it, registers with AICIS for each year it does. More on AICIS registration.

A food with a novel ingredient has its own step: novel foods must be listed in the Code before they are used. Neither pathway skips the brief, the formula, the label or manufacturing, so the stages above still set most of the timeline.

Where we come in

We run formulation, regulatory work and sourcing side by side, with manufacturing partners already in place, so most stages don't wait for the one before. That is how we take a product from concept to shelf in as little as six months. See the Launch Engine, check the fit or brief a project.