News from EDQM: Standard setting for homeopathic preparations
Aug 01, 2022
Recent news from the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe confirms its vital role in setting quality standards for homeopathic medical products and ensuring harmonisation at European level.
Revised Guide for the elaboration of monographs on homoeopathic preparations
At its 172nd session, the European Pharmacopoeia (Ph. Eur.) Commission of EDQM approved the revised version of the Guide for the elaboration of monographs on homoeopathic preparations (Edition 2022). This guide lays the basis for all monographs, defining the preparation and allowing for the proper identification of homeopathic preparations.
This is the first time the guide has been updated and it now includes examples drawn from the latest new monographs.
The main changes are listed in the guide. In particular, it has now been updated in line with the new Ph. Eur. policy on assays. An assay continues to be required for toxic stable components (no change) but a limit test can be used instead of an assay for unstable toxic components. For non-toxic components, the assay has been replaced by a semi-quantitative fingerprint determination of at least two appropriate markers (to be described under Tests) using, for example, high-performance thin-layer chromatography. A pilot phase on this is still ongoing, so this possibility has not yet been included in the updated guide.
The updated guide in now available on the EDQM website for download in both English and French.
Six new monographs
After several years of work towards European harmonisation by experts and stakeholders from many different professional backgrounds, six monographs have now been adopted and will be published in the 11th edition of the Ph. Eur. They will be implemented from 1 January 2023.
The newly adopted monographs are both updated and new. They include Hyoscyamus, Mandragora, Bryonia, Ephedra, Stramonium and Ferrum metallicum.
ECHAMP is grateful to EDQM and its team for its continued hard work on these projects. The commitment to setting harmonised quality standards for homeopathic manufacturing methods and preparations is essential to the future of our industry, enabling us to deliver medicinal products of the highest quality throughout Europe.