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Homeopathic medicinal products from biological origin

19 May 2016

The Homeopathic Medicinal Products Working Group (HMPWG) has updated its safety guidance on homeopathic medicinal products from biological origin, outlining the requirements to be fulfilled by these medicinal products in the registration procedure.

Homeopathic medicinal products of biological origin are diverse in nature. The preparations include materials from a wide range of species, from humans to bacterial and viral agents and from healthy as well as from pathological sources.

HMPWG guidance on the safety of homeopathic medicinal products from biological origin was first adopted by HMA in July 2007. The topic was reviewed again by HMPWG in 2014 and, following a new consultation, the guidelines were submitted to the Biologics Working Party of the European Medicines Agency (BWP) for third party opinion. BWP is composed of 26 European experts selected for their specific expertise in this field and provides recommendations to the European Medicines Agency's scientific committees on all matters relating directly or indirectly to quality and safety aspects relating to biological and biotechnological medicines. The new Points to Consider on Safety of Homeopathic Medicinal Products from Biological Origin were adopted by HMPWG in April this year, and have now been published on the HMPWG website.

This guidance applies only to homeopathic medicinal products subject to simplified registration. It includes those starting materials obtained from:

  • humans, e.g. human cell lines, healthy tissues or fluids, or nosodes such as human lesions/infected materials;
  • animals e.g. whole animals, organs, tissues, animal secretions, toxins, healthy or diseased tissues and extracts (nosodes), blood products, parasites, animal cell lines;
  • micro-organisms (e.g. bacteria, viruses, microscopic fungi, plant parasites).

It does not include plant materials or macroscopic fungi.

The main difference in the revised guidelines is the addition of a new annex, a decision tree on the evaluation of safety of homeopathic medicinal products manufactured from raw material of human, animal or microbiological origin and establishment of first safe preparation. This has been adapted from the article ‘Viral safety in homeopathic medicinal products’ by Schultz et al.. Pharmaeuropa Bio & Scientific Notes.