Adoption of International Scientific Guidelines in Australia

Following a public consultation process between 21 November 2024 – 16 January 2024, the TGA has adopted the following 19 international scientific guidelines:

1. Annex 1 WHO guidelines on nonclinical evaluation of vaccines - WHO Technical Report Series, No. 927, 2005.
2. Annex 2 - guidelines on the non-clinical evaluation of vaccine adjuvants and adjuvanted vaccines, TRS No 987 - WHO Technical Report Series No. 987, 2014.
3. Bioequivalence for immediate-release solid oral dosage forms – M13A - ICH M13 A.
4. Quality Working Party questions and answers on API mix – EMA/CHMP/CVMP/QWP/152772/2016
5. Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2) – EMA/873138/2011 Rev 2*
6. Guideline on good pharmacovigilance practices (GVP) Module VIII – Post authorisation safety studies (Rev 3) - EMA/813938/2011 Rev 3*
7. Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract – CPMP/EWP/239/95 Rev. 1, Corr.1*
8. Guideline on the clinical evaluation of anticancer medicinal products - EMA/CHMP/205/95 Rev.6 
9. Guideline on the assessment of clinical safety and efficacy in the preparation of EU herbal monographs for well-established and traditional herbal medicinal products – EMA/HMPC/104613/2005 Rev. 1
10. Guideline on control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “substances for pharmaceutical use” and general chapter “control of impurities in substances for pharmaceutical use” – EMA/CVMP/QWP/907965/2022
11. Appendices to Guideline on epidemiological data on blood transmissible infections – EMA/735037/2015 Rev.1
12. Guideline on epidemiological data on blood transmissible infections – EMA/CHMP/BWP/548524/2008 rev 1
13. Guideline on the chemistry of active substances – EMA/454576/2016
14. Data Standards for Drug and Biological Product Submissions Containing Real-World Data Guidance for Industry – Real-World Data/Real-World Evidence (RWD/RWE)
15. Aliskiren film-coated tablet 150mg and 300mg product specific bioequivalence guidance – EMA/CHMP/291450/2018
16. Apixaban film-coated tablet 2.5 and 5mg product -specific bioequivalence guidance – EMA/CHMP/291499/2018
17. Drug Interaction Studies M12 – ICH M12
18. Nonclinical Biodistribution Considerations for Gene Therapy Products S12 – ICH S12
19. ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - ICH Q5A(R2); EMA/CHMP/ICH/804363/2022

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 is guidelines@health.gov.au.