The guidance environment: updates from HMPWG

Sep 03, 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

The minutes of the HMPWG’s 21st meeting, held in Strasbourg in May, are now available on the HMPWG website.

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 published the ‘Third list entries of stocks for which homeopathic use is justified. This new list is in addition to the second list, and includes 40 stocks, each with a definition of the raw material and its pharmacopoeial references (European Pharmacopoeia, the French Pharmacopoeia and/or the German Homoeopathic Pharmacopoeia (HAB)). ECHAMP, along with two other organisations, AESGP and ECH (European homeopathic doctors), submitted comments on this list during a consultation, and HMPWG has also published a useful and transparent overview of all comments received, with its own response and the outcome of the feedback, highlighting points that will be further considered by the relevant HMPWG sub-group.

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

The HMPWG launched a consultation on the important subject of first safe dilutions (FSDs) in 2012; the first comments were compiled and published in 2014, followed by a further consultation on six specific topics relating to this subject, including toxicological data to be submitted, application of the FSD, contraindications, combination products, threshold of toxicological concern (TTC) and additional safety factors. Three organisations – ECHAMP, ECH and AESGP – submitted answers to these questions, and HMPWG has now published these answers in two different documents, one on the first five questions, and one on the sixth question. In each case, HMPWG has given its own response to the specific amendments suggested by the stakeholders.

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.

Quality

Furthermore the HMPWG is working on microbiological testing limits for homeopathic preparations, on the applicability of the Minnesota Convention on Mercury to HMPs as well as on the requirements of raw material suppliers in Module 3.

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.