HMPWG consultations: quality questions and nosodes

The Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Medicines Agencies (HMA) has published two new documents for public consultation:

• Questions and answers document on the quality of homeopathic medicinal products: The intention of this draft document is to clarify open issues that HMPWG has identified through its work in the dossiers. The questions and answers form part of an ongoing process in the HMPWG quality sub-working group. This document includes draft questions and answers 4 – 7 on stability, intermediate dilutions, process validation, and specification and testing. The final document on Questions 1 – 3 has not yet been published by HMPWG.
• Guidance on module 3.2.S for nosodes: This draft document updates the existing guidance on module 3 (published in 2007) with the aim of providing clarification for an application dossier for homeopathic medicinal products containing nosodes, defined as homeopathic preparations made from products of human or animal disease processes, pathogens or their metabolic products, the decomposition products of animal organs, or cultured microorganisms. It is to be read in conjunction with the ‘Points to consider on safety of homeopathic medicinal products of biological origin’.

ECHAMP will compile and submit comments on these two consultations and invites all members to submit feedback on the documents – please send your comments to the office by 16 April 16 2018.