20/21 November 2019
GMP News No. 865
New HMPC Guidelines for Herbal Medicinal Products
It is the task of HMPC to create Community Monographs for "well-established" and for traditional herbal medicinal products. Furthermore, it is supposed to write down a Community list of traditional herbal medicinal products. Here it is important to define the borderline between the "well-established" products with sufficient scientific background on the one hand and the traditional herbal medicinal products used solely on the basis of long-standing experience on the other hand. This new HMPC Guideline explains how the data for "well-established" and for traditional herbal medicinal products should be assessed. For both product groups, there are detailed descriptions of the data on clinical efficacy and safety that have to be handed in.
The complete document can be found here:
This guideline defines the minimum requirements on non-clinical data
(e.g. toxicological information) that should be indicated together with
bibliographic data when applying for the registration of a
"well-established" herbal medicinal product. If these minimum
requirements cannot be met by the existing literature, a "mixed
application" becomes mandatory, possibly requiring further non-clinical
tests. The guideline shows which non-clinical safety aspects have to be
addressed in the expert report in case of simplified registration of
traditional herbal medicinal products and which non-clinical tests may
also be necessary to prove product safety.
The complete guideline can be downloaded via the following link: