On 26 July 2007, the European Medicines Agency (EMEA) published the draft of
the "Guideline on Quality of Combination Herbal Medicinal Products /
Traditional Herbal Medicinal Products".
This guideline refers to herbal medicinal products containing combinations
of herbal drugs and/or herbal preparations. In some of these combination
products it is difficult or sometimes even impossible to determine identity
and potency of the individual herbal substances / herbal preparations in the
finished product. For this case, the guideline describes alternative
approaches and strategies. It is not permitted to simply omit certain tests.
Especially the significance of design and validation of the manufacturing
process is emphasised, in connection with a detailed documentation of each
manufacturing step. Here, in-process controls also assume particular
importance, e.g. in so far as identification and potency that cannot be
tested on the finished product any more are already conducted during
manufacturing in the form of in-process controls. This is illustrated with
the help of two decision trees at the end of the draft document.
In such a case it is recommended that the applicant contact the competent
registration authority. And it is expected that the data concerning
manufacturing and process validation are handed in together with the dossier
for a marketing authorisation/registration!
On 26 July 2007, too, the EMEA published the final "Guideline on
Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal
Products / Traditional Medicinal Herbal Products in the SPC".
This guideline describes general criteria for the standardised declaration
of herbal substances/ preparations in (traditional) herbal medicinal
products. The recommendations on the declaration are shown by means of a
number of examples.
The complete documents can be downloaded from the following addresses:
Guideline on Quality of Combination Herbal Medicinal Products / Traditional
Herbal Medicinal Products
Guideline on Declaration of Herbal Substances and Herbal Preparations in
Herbal Medicinal Products / Traditional Medicinal Herbal Products in the SPC