GMP clearance in 2026: the extensions, the three-year rule and the new portal
Since mid-2025 the TGA has extended thousands of overseas GMP clearances without an application, gone back to a three-year limit on the inspection evidence it accepts, worked its queue down and put PIC/S version 17 into force. What it means for a supplement made overseas.
Each overseas site that carries out a step of a listed medicine's manufacture needs a TGA GMP clearance, obtained by the Australian sponsor, unless that step is exempt. Since the middle of 2025 the TGA has changed how it handles them: it extended thousands without an application, tightened the evidence it accepts, worked down its queue and moved to a new version of the GMP standard, with a new portal to come.
Two years added, without an application
To clear a backlog, the TGA extended clearances in bulk. In its words, "All existing MRA and non-sterile API CV GMP Clearances due to expire between 1 July 2025 and 30 June 2027 will be extended for a period of 2 years", and "Sponsors or Agents do not need to apply for this extension." That meant MRA clearances, and compliance verification clearances for non-sterile active pharmaceutical ingredients. It processed 6,258 extensions in all, and said it would run abbreviated evaluations for manufacturers performing certain lower-risk activities.
The three-year rule is back
At the same time, the TGA returned to its pre-pandemic rule for compliance verification: from 1 July 2025 it no longer accepts evidence from an inspection more than three years old. A site whose last inspection by a recognised regulator was longer ago than that can't be cleared through compliance verification on that evidence.
The queue is shorter
The TGA's GMP clearance dashboard, with data from 1 June 2026, reports its queue of compliance verification applications falling from 2,185 at the end of June 2025 to 1,203, and says MRA applications have been consistently processed within its target time. The TGA took target processing timeframes out of its guidance in November 2023; the dashboard is where it now reports them.
PIC/S version 17
From 1 September 2025, version PE009-17 of the PIC/S Guide to GMP applies to the manufacture of medicines in Australia, unless they are exempt, with its Annexes 4, 5 and 14 not adopted.
A new portal
Answering questions from its December 2025 webinar, the TGA said that "All new GMP clearances will be submitted on the portal once it goes live in mid-late 2026", with its legacy systems supported until then.
What it means for a supplement made overseas
- The extensions don't help a new site. They covered only existing MRA clearances and compliance verification clearances for non-sterile active ingredients, so a compliance verification clearance for a finished product wasn't extended. A new overseas site still needs its own clearance, applied for by the sponsor, and each sponsor needs its own even if the factory already supplies other Australian brands.
- Supplement factories often need an inspection. The two desktop routes rest on an inspection by a recognised regulator for a human medicinal product, and the TGA says they are unavailable for some listed medicines, including dietary supplements, that may not be regulated as medicines in other countries.
- Check the date of the last inspection. For compliance verification, evidence older than three years won't do.
- Renew early. The TGA asks for a renewal at least six months before a clearance expires, and one expired for more than 12 months can't be reinstated.
Our GMP clearance guide covers the three routes, the evidence, the 2026–27 fees and renewal in full, and our manufacturing page how we choose manufacturing partners.
Sources
General information, checked against these sources on 22 October 2026. It isn't advice on a particular product or site.
- GMP clearance backlog reduction strategy and the completed extensions, Therapeutic Goods Administration
- GMP clearance Sponsor Information Dashboard (SID), Therapeutic Goods Administration
- How to obtain GMP clearance through inspection reliance, version 18.6, May 2025, and GMP clearance: application and submission user guide, Therapeutic Goods Administration
- The PIC/S Guide to GMP for medicinal products, version 17, Therapeutic Goods Administration
- TGA digital transformation webinar: questions and answers, from the webinar of 2 December 2025, Therapeutic Goods Administration
Related guides
Related guides
TGA GMP clearance: making a listed medicine overseas
When an overseas factory needs TGA GMP clearance for a listed medicine: the MRA, compliance verification and inspection routes, evidence, fees and renewal.
How to start a supplement brand in Australia: the steps from idea to shelf
Starting a supplement brand in Australia, step by step: the pathway, ingredients and claims, the TGA sponsor, manufacturing, the label, the listing and launch.
How to choose a supplement manufacturer in Australia
Choosing a supplement manufacturer in Australia: what a TGA licence covers and how to check it, sites overseas, the GMP agreement and how each batch is tested.
