Adoption of international scientific guidelines in Australia

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.

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. 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.