Adoption of International Scientific Guidelines in Australia R01-2025

Overview

1. The Therapeutic Goods Administration (TGA) is seeking feedback on whether or not certain international scientific guidelines should be adopted.

Prior to adopting any international scientific guideline, the TGA undertakes an extensive process of internal and external consultation to ensure the international scientific guideline is consistent with prevailing requirements in Australia.

The TGA has approximately 370 current adopted international scientific guidelines.

Guidelines being considered for adoption

There are 23 international scientific guidelines being considered in this consultation, as follows:

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 products2/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

Why your views matter

The TGA closely aligns its regulatory approaches to therapeutic products with those of comparable international regulatory counterparts wherever possible.

Technical data requirements for applications to register or vary the registration of medicines in Australia are closely aligned with requirements set out in relevant:

• European Union (EU) Guidelines
• Guidelines issued by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use
• Food and Drug Administration (FDA) Guidelines

International scientific guidelines are not limited to prescription medicines, but may also apply to over-the-counter (OTC), complementary and some listed medicines and medical devices. It is important that sponsors review the relevant international scientific guidelines that are adopted in Australia prior to manufacturing and supplying a medicine.

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.

We are now seeking feedback on whether or not certain international scientific guidelines, as detailed in the following online survey, should be adopted.