17/18 March 2021
On 12 July 2016 EMA's Working Group on herbal medicinal products (HMPC/Committee on Herbal Medicinal Products) published a concept paper on the revision of the guideline on non-clinical documentation for herbal medicinal products.
A first document on that topic was issued in 2006. The contents of this document are still applicable. A revision had been necessary, though, to take into consideration the newest developments of the last 10 years.
The new developments include:
1. The consideration of the two guidelines on genotoxic testing:
"Guideline on the assessment of genotoxicity of herbal substances/preparations" (EMEA/HMPC/107079/2007)
"Guideline on selection of test materials for genotoxicity testing for Traditional Herbal Medicinal Products/Herbal Medicinal Products" (EMEA/HMPC/67644/2009).
2. With regard to test design and assessment, the testing of multicomponent mixtures has to be included in the new guideline.
3. With the new guideline ICH S2 (R1) on genotoxicity testing and the interpretation for use on humans in guideline CHMP/ICH/126642/2008, the concept of these tests has been now extended to in vivo tests.
More information is available in the complete "Concept paper on the revision of the "Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for simplified registration".