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Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products - guidance for industry

Draft guidance

We have adopted this International Scientific Guideline.

Last updated

About this guideline

Adopted by the TGA: 27 February 2023

Overseas publication date: December 2021

Categories: FDA | Real World Data/Real World Evidence (RWD/RWE)

TGA annotations:

The general principles of this guideline are adopted. Please note that any references to FDA processes are not applicable in submissions to the TGA.

The TGA will monitor the US FDA status of this draft and will consider if further consultation or annotation is required once it moves to a fully adopted guideline. Further consultation will only occur if the principles are materially altered.

  • Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
  • The pdf version of this document was downloaded and saved from the U.S. Food and Drug Administration (U.S. FDA) site on 20 February 2023.

For more information see International scientific guidelines adopted in Australia.

This webpage on the TGA website was printed on 14 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/international-scientific-guidelines/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug-and-biological-products-guidance-industry

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