EMEA Publishes New HMPC Guideline on Combination Herbal Medicinal Products

GMP News
9 October 2007
 

EMEA Publishes New HMPC Guideline
on Combination Herbal Medicinal Products

 
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
 

What is the current state with regard to marketing authorisations and registrations of herbal medicinal products and traditional herbal medicinal products in the individual European member states? You will get a detailed presentation of today's situation in the most important European herbal markets at the ECA conference "Herbal Medicinal Products in Europe - Harmonisation Achieved?" to be held in Berlin on 13-14 November 2007. Among the speakers are the following representatives from European registration authorities:

  • Dr Linda Anderson, MHRA, UK
  • Dr Per Claeson, MPA, Sweden
  • Dr Werner Knöss, BfArM, Bonn, Germany
  • Prof Dr Reinhard Länger, AGES PharmMed, Austria

This conference is an important meeting place for all those who are involved in registering or obtaining a marketing authorisation for herbal medicinal products.


Author::
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)
 

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK