Adoption of International Scientific Guidelines in Australia R01-2024

Overview

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 19 international scientific guidelines being considered in this consultation, as follows:

1. Annex 1 WHO guidelines on nonclinical evaluation of vaccines
2. Annex 2 – Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines
3. Bioequivalence for immediate-release solid oral dosage forms – M13A
4. Quality Working Party questions and answers on API mix
5. Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2)
6. Guideline on good pharmacovigilance practices (GVP) Module VIII – Post authorisation safety studies (Rev 3)
7. Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract
8. Guideline on the clinical evaluation of anticancer medicinal products
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
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”
11. Appendices to Guideline on epidemiological data on blood transmissible infections
12. Guideline on epidemiological data on blood transmissible infections
13. Guideline on the chemistry of active substances
14. Data Standards for Drug and Biological Product Submissions Containing Real-World Data Guidance for Industry
15. Aliskiren film-coated tablet 150mg and 300mg product specific bioequivalence guidance
16. Apixaban film-coated tablet 2.5 and 5mg product -specific bioequivalence guidance
17. Drug Interaction Studies M12
18. Nonclinical Biodistribution Considerations for Gene Therapy Products S12
19. ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin

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.