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Guideline on the assessment of clinical safety and efficacy in the preparation of EU herbal monographs for well-established and traditional herbal medicinal products

We have adopted this International Scientific Guideline - EMA/HMPC/104613/2005 Rev. 1

About this guideline

Adopted by the TGA: 13 March 2025

Overseas effective date: 19 September 2017

Replaces: Guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinal products (Draft revision 1) (EMA/HMPC/104613/2005 Rev 1) (Adopted by the TGA 28 February 2020) 

Categories: Multidisciplinary | Herbal medicinal products

TGA annotations: 

Applicants must be able to demonstrate an established tradition of use for traditional use indications in Australia. Please refer to the Understanding listed and registered complementary medicine regulation, which identify traditional use as generally equating to three generations of human use.

 

  • 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.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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