Adoption of International Scientific Guidelines in Australia - R01/2025

Following a public consultation process between 24 November 2025 – 10 February 2026, the TGA has adopted the following 23 international scientific guidelines:

1. ICH guideline S1 Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals
2. Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668)
3. Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations IV: Paediatric population
4. ICH guideline Q9 (R1) on quality risk management
5. Guideline on quality of herbal medicinal products/traditional herbal medicinal products – Final
6. Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 2
7. Guideline on the investigation of subgroups in confirmatory clinical trials
8. Ezetimibe tablet 10 mg product-specific bioequivalence guidance
9. Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products - Guidance for Industry
10. Gefitinib film-coated tablet 250 mg product-specific bioequivalence guidance
11. Guideline on adjuvants in vaccines for human use
12. Guideline on clinical evaluation of vaccines
13. Guideline on Stability Testing: Stability testing of existing active substances and related finished products
14. ICH Q2(R2) guideline on validation of analytical procedures - Step 5 - Revision 1
15. Guideline on manufacture of the finished dosage form
16. Guideline on quality aspects included in the product information for vaccines for human use - Revision 1
17. Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products
18. Guideline on the development of new medicinal products for the treatment of Crohn’s Disease
19. Guideline on clinical investigation of recombinant and human plasma-derived factor IX products
20. CHMP Reflection paper on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products - Revision 3
21. Guideline on the quality of water for pharmaceutical use
22. Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs
23. Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells

While international scientific guidelines that are adopted in Australia are generally not mandated by legislation, they provide guidance to sponsors to assist them to meet the legislative requirements. Any deviation from a guideline relevant to an application to register or vary the registration of a medicine must be justified.

Enquiries

For enquiries relating to the consultation please email isguidelines@health.gov.au.