International scientific guideline: Points to consider on the calculation and reporting of the prevalence of a condition for orphan designation

About this guideline

TGA adopted date: 26 Mar 2002

Categories: Clinical efficacy and safety | General (clinical)

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TGA annotations

p>The TGA has published guidance on eligibility criteria and supporting documentation for orphan drug designation in accordance with Part 3B of the Therapeutic Goods Regulations 1990.

For more information see International scientific guidelines adopted in Australia.

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.