Adoption of International Scientific Guidelines in Australia R01-2023

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

1. ICH M9 guideline on biopharmaceutics classification system-based biowaivers Step 5
2. Nonclinical safety testing in support of development of paediatric pharmaceuticals S11
3. ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population Step 5 - Addendum
4. ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5
5. Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies
6. ICH Electronic Common Technical Document (eCTD) v4.0 Implementation Guide v1.5
7. Guideline on the evaluation of anticancer medicinal products in man
8. ICH guideline E8 (R1) on general considerations for clinical studies Step 5
9. ICH guideline Q3C (R8) on impurities: guideline for residual solvents Step 5
10. ICH M7(R2) Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk Step 5
11. ICH M7(R2) Addendum on application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes Step 5
12. ICH guideline M10 on bioanalytical method validation and study sample analysis Step5
13. ICH guideline Q3D (R2) on elemental impurities Step 5

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.

What happens next

Feedback collated during this consultation process will assist the TGA in determining whether or not the international scientific guidelines specified in this consultation should be adopted.