The guidance environment: updates from HMPWG
03 Sep 2015
Newly published documents give a welcome update on the work of the Homeopathic Medicinal Products Working Group of the Heads of Medicines Agencies (HMPWG), including the minutes of its most recent meeting, and important feedback on its work on the justification of homeopathic use and on first safe dilutions.
HMPWG Meeting report
They report that HMPWG has agreed to establish a permanent secretariat; in addition it has approved documents on homeopathic use and first safe dilution (see below); following the consultation on the Points to Consider on Safety of Homeopathic Medicinal Products from Biological Origin, earlier this year (see ECHAMP News), the document has been updated and adopted by the HMPWG, although not yet been published.
HMPWG also agreed the contents of a letter to the European Commission in response to its request for a proposal for a definition of the phrase “homeopathic medicinal products administered orally or externally,” as included in the legislation.
The next meeting of HMPWG will be held in Netherlands 11-12 November.
Justification of homeopathic use
HMPWG has responded positively to ECH’s request to include all available descriptions in the list, and to ECHAMP’s request to include Latin names and reference to national as well as European pharmacopoeias, where they exist. However, in response to a comment from AESGP, it has made it very clear that it does not agree that all substances or stocks for homeopathic use described in the European Pharmacopoeia, the French Pharmacopoeia or the German Homoeopathic Pharmacopoeia (HAB) should automatically be included in the list. It argues that a pharmacopoeia reference is not a sufficient way to justify homeopathic use.
First safe dilutions
While it is helpful to have a clear response from HMPWG to each of the issues raised, these answers show that there is still a significant divergence of opinion between ECHAMP and HMPWG as regards the calculation and the application of the FSD. HMPWG’s policy is that the FSD shall represent the most conservative approach of the toxicological assessment.
What does this mean? It is clear to ECHAMP that the original and most welcome intention of the FSD list to simplify the dossier workload and assessment for simplified registration procedures for applicants and agencies is far from being met. In practice, a module 4 will still be needed in most cases of Art. 14 registration procedure to justify the safety of a specific product. The workload for the industry is even higher because the conservative FSD calculations published by HMPWG are of theoretical value and need to be thoroughly revised when published even if no registration procedure with the stocks in question is foreseen.
At its last meeting, in May, HMPWG decided to discuss the drafting of guidance documents on Module 4 and the FSD calculation in its next meeting.