Adoption of International Scientific Guidelines in Australia R02-2024

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

1. ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
2. Guideline on quality documentation for medicinal products when used with a medical device
3. Guideline on good pharmacovigilance practices (GVP) Module I –Pharmacovigilance systems and their quality systems

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.