Adoption of International Scientific Guidelines in Australia R01-2026

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

1. Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products 
2. Guideline on the requirements for demonstrating Therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)
3. Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis
4. Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus 
5. Guideline on process validation for finished products - information and data to be provided in regulatory submissions
6. Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products 
7. Guideline on Immunogenicity assessment of therapeutic proteins 
8. A SELECTIVE APPROACH TO SAFETY DATA COLLECTION IN SPECIFIC LATE-STAGE PRE-APPROVAL OR POST-APPROVAL CLINICAL TRIALS E19
9. CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL (CESHARP) M11
10. Guideline on influenza vaccines – submission and procedural requirements
11. Reflection paper on a tailored clinical approach in biosimilar development

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.