Human Medicines - Herbal Medicinal Products - Guidance Documents

Guidance Documents
Most of the guidelines can also be found in the Human Medicines section of this website, under Human Guidelines. The documents are divided into the following categories:

Quality
Clinical efficacy and safety
Non-clinical
Quality
- EMEA/HMPC/67644/09 Draft Guideline on selection of test materials for genotoxicity testing for traditional herbal medicinal products/herbal medicinal products (Released for consultation Jun 2009) (Deadline for comments 15 Sep 2009)
- EMEA/HMPC/3626/09 Draft Reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products (Released for consultation Jan 2009) (Deadline for comments 15 May 2009)
- EMEA/HMPC/CHMP/CVMP/287539/05 Rev 1

Draft Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC (Released for consultation Oct 2008)
- EMEA/531300/08 List of questions & answers (Q&A) received during the HMPC assessors training on quality issues emerging for herbal medicinal products (held on 7 December 2007, EMEA)
- EMEA/HMPC/186645/08 Draft reflection paper on level of purification of extracts to be considered as herbal preparations (Released for consultation Nov 2008) (Deadline for comments 15 Apr 2009)
- EMEA/HMCP/451978/08 Concept paper on the development of a guideline on preparation on herbal teas
- EMEA/HMPC/253629/07 final Reflection paper on Markers used for quantitative and qualitative analysis of Herbal Medicinal Products and traditional Herbal Medicinal Products

- EMEA/HMPC/297843/08 Overview of comments received during the consultation period for draft Reflection paper on Markers used for quantitative and qualitative analysis of Herbal Medicinal Products and traditional Herbal Medicinal Products
- EMEA/HMPC/253629/07 Reflection paper on Markers used for quantitative and qualitative analysis of Herbal Medicinal Products and traditional Herbal Medicinal Products

- EMEA/HMPC/CHMP/CVMP/287539/05 Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC
- EMEA/HMPC/230249/2006 Overview of comments received during the consultation period for Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC
- EMEA/HMPC/CHMP/CVMP/214869/06 Guideline on Quality of Combination Herbal Medicinal Products / Traditional Herbal Medicinal Products (Adopted April 2008)
- EMEA/HMPC/559281/2007 Overview of comments received on the Draft Guideline on Quality of Combination Herbal Medicinal Products / Traditional Herbal Medicinal Products
- EMEA/HMPC/125562/06 Reflection Paper on the use of Fumigants (Adopted October 2006)
- EMEA/HMPC/CHMP/CVMP/58222/06 Concept Paper on Quality of Combination Herbal Medicinal Products/Traditional Herbal Medicinal Products (Released for consultation June 2006)
- EMEA/HMPC/CHMP/CVMP/287539/05

Draft Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC (Released for consultation June 2006)
- EMEA/HMPC/246816/05 Guideline on Good Agricultural and Collection Practice for starting materials of Herbal Origin (Adopted January 2006)
- EMEA/HMPC/11138/06 Overview of comments on the GACP Guideline
CPMP/QWP/2819/00 Rev 1 Guideline on Quality of Herbal Medicinal Products/Traditional Herbal Medicinal Products
- EMEA/CHMP/CVMP/QWP/40683/06 Overview of comments on the Draft Guideline Quality of Herbal Medicinal Products/Traditional Herbal Medicinal Products
- CPMP/QWP/2820/00 Rev 1

Guideline on specifications: Test procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products / Traditional Herbal Medicinal Products
- EMEA/CHMP/CVMP/QWP/40728/06 Overview of comments on the Draft Guideline on Test procedures and Acceptance

Safety:
- EMEA/HMPC/85114/2008 Reflection paper on ethanol content in herbal medicinal products and traditional herbal medicinal products used in children
- EMEA/HMPC/315413/08 Concept paper on Selection of test materials for genotoxicity testing for Traditional Herbal Medicinal Products/Herbal Medicinal Products
- EMEA/HMPC/107079/07 Guideline on the assessment of genotoxicity of herbal substances/preparations
- EMEA/HMPC/232888/08 Overview of comments received on draft Guideline on the assessment of genotoxic constituents in herbal substances/preparations
- EMEA/HMPC/317913/06 Reflection Paper on the risks associated with furocoumarins contained in preparations of Angelica archangelica L. (Adopted October 2007)
- EMEA/HMPC/277293/07 Overview of comments received on draft Reflection Paper on the risks associated with furocoumarins contained in preparations of Angelica archangelica L.

Commets received during the public consultation
Comments received during the public consultation on Reflection paper on the risks associated with furocoumarins contained in preparations of Angelica archangelica L.

* EMEA/HMPC/413271/06

Concept paper on the development of a guideline on the assessment of genotoxic constituents inherbal substances/preparations (Released for consultation October 2006)
- EMEA/HMPC/32116/05 Guideline on Non-Clinical Documentation for Herbal Medicinal Products in Applications for Marketing Authorisation (Bibliographical and Mixed Applications) and in Applications for Simplified Registration (Adopted July 2006)
- EMEA/HMPC/132154/06 Overview of comments received on "Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for simplified registration"
- EMEA/HMPC/246736/05 Public Statement on "CPMP List of Herbal Drugs with serious risks, dated 1992" (Adopted November 2005)

Efficacy:
- EMEA/HMPC/102655/07

Reflection paper on the adaptogenic concept (Adopted May 2008):
- EMEA/HMPC/104613/05 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 (Adopted September 2006)
- EMEA/HMPC/314947/06 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 community list for traditional herbal medicinal products/substances/preparations"
- EMEA/HMPC/166326/05 Guideline on the Clinical Assessment of fixed Combinations of Herbal Substances / Herbal Preparations (Adopted January 2006)
- EMEA/HMPC/419395/05 Overview of Comments Received on "Guideline on the Clinical Assessment of fixed Combinations of Herbal Substances / Herbal Preparations"

Organisational matters:
- EMEA/HMPC/71049/07 Guideline on the use of of the CTD Format in the preparation of a registration application for traditional herbal medicinal products
- EMEA/HMPC/539645/07 Overview of Comments received on "Draft Guideline on the use of of the CTD Format in the preparation of a registration application for traditional herbal medicinal products

Pharmacovigilance:
- EMEA/269259/06 EMEA Public Statement on herbal medicinal products containing Cimicifugae racemosae rhizoma (Black cohosh, root)
- EMEA/HMPC/269258/06 Rev 1 Assessment of case reports connected to herbal medicinal products containing Cimicifugae racemosae rhizoma (Black cohosh, root) (Adopted revised version May 2007)
- EMEA/HMPC/138309/05 Public Statement on Chamomilla containing herbal medicinal products (Adopted March 2006)
- EMEA/379986/05 Overview of Comments received on "Public Statement on Chamomilla containing herbal medicinal products"
- EMEA/HMPC/138139/05 Public Statement on the allergenic potency of herbal medicinal products containing soya or peanut protein (Adopted January 2006)
- EMEA/381405/05 Overview of Comments received on "Public Statement on the allergenic potency of herbal medicinal products containing soya or peanut protein"
- EMEA/HMPC/139215/05 Public Statement on the use of herbal medicinal products containing asarone (Adopted November 2005)
- EMEA/HMPC/138381/05 Public Statement on the risks associated with the use of herbal products containing Aristolochia species (Adopted November 2005)
- EMEA/HMPC/138386/05

* Public Statement on the use of herbal medicinal products containing pulegone and menthofuran (Adopted November 2005)
- EMEA/HMPC/138379/05

* Public Statement on Capsicum / capsaicin containing herbal medicinal products (Adopted November 2005)
- EMEA/HMPC/137212/05 Public Statement on the use of herbal medicinal products containing estragole (Adopted November 2005)
- EMEA/HMPC/138363/05 Public Statement on the use of herbal medicinal products containing methyleugenol (Adopted November 2005)
- EMEA/381090/05 Overview of Comments received on "Public Statement on the use of herbal medicinal products containing estragole" and on "Public Statement on the use of herbal medicinal products containing methyleugenol"


Questions & Answers:
- EMEA/HMPC/151144/06 Corr
Overview of Questions and Answers relating to Technical/Scientific Issues

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