Assessment of clinical safety and efficacy in the preparation of EU herbal monographs for well-established and traditional herbal medicinal products - Scientific guideline

This guideline describes the legal background and recommendations for the assessment of data that are used to prepare European Union herbal monographs (formerly called Community herbal monographs) on herbal medicinal products and the European Union list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products. The areas of herbal medicinal products with well-established medicinal use and traditional herbal medicinal products are addressed.

Keywords: Herbal medicinal products, clinical safety, efficacy, traditional use registration, marketing authorisation, European Union herbal monographs, European Union list of traditional herbal substances, preparations or combinations thereof

Current effective version

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

Adopted Reference Number: EMA/HMPC/104613/2005 Rev. 1 Summary:

This guideline describes the legal background and recommendations for the assessment of data that are used to prepare European Union herbal monographs (formerly called Community herbal monographs) on herbal medicinal products and the European Union list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products. The areas of herbal medicinal products with well-established medicinal use and traditional herbal medicinal products are addressed.

Document history - Revision 1 (current version)

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

Adopted Reference Number: EMA/HMPC/104613/2005 Rev. 1 Summary:

This guideline describes the legal background and recommendations for the assessment of data that are used to prepare European Union herbal monographs (formerly called Community herbal monographs) on herbal medicinal products and the European Union list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products. The areas of herbal medicinal products with well-established medicinal use and traditional herbal medicinal products are addressed.

Overview of comments received on "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"

Reference Number: EMA/HMPC/183134/2017 Rev. 1 Summary:

Overview of comments received on “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” (EMA/HMPC/104613/2005 Rev. 1)

Draft 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: consultation closed Consultation dates: 01/09/2016 to 30/11/2016 Reference Number: EMA/HMPC/104613/2005 Rev. 1 Summary:

This guideline describes the legal background and recommendations for the assessment of data that are used to prepare European Union herbal monographs (formerly called Community herbal monographs) on herbal medicinal products and the European Union list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products. The areas of herbal medicinal products with well-established medicinal use and traditional herbal medicinal products are addressed.

Concept paper on the revision of the 'Guideline on the assessment of clinical safety and efficacy in the preparation of Community herbal monographs for well- established and of Community herbal monographs/entries to the...

Draft: consultation closed Consultation dates: 16/10/2015 to 31/01/2016 Reference Number: EMA/HMPC/427510/2015 Summary:

In 2006, the “Guideline on the assessment of clinical safety and efficacy in the preparation of Community herbal monographs for well-established and of Community herbal monographs/entries to the community list for traditional herbal medicinal products/substances/preparations” was published. In principle, the content of the guideline is still valid, but an update of the document to current standards is required taking into account advances over the last 10 years as well as established practice and legal interpretations.

Document history - First version

Guideline on the assessment of clinical safety and efficacy in the preparation of community herbal monographs for well-established and of community herbal monographs / entries to the community list for traditional herbal...

Adopted Reference Number: EMEA/HMPC/104613/2005 Legal effective date: 01/03/2007

Overview of comments received on HMPC guideline on the assessment of clinical safety and efficacy in the preparation of community herbal monographs for well-established and of community herbal monographs / entries to the...

Reference Number: EMEA/HMPC/314947/2006