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New HMPWG guidance: first safe dilutions and nosodes

15 Jan 2019

The Homeopathic Medicinal Products Working Group of the Heads of Medicines Agencies (HMPWG) has published five new finalised documents on its website.

First safe dilutions

In November, it published the Fourth List of First Safe Dilutions,  the Overview of comments on the draft document "Fourth List of First Safe Dilutions and the Consolidated List FSD 1-4, a final compilation of the previous adopted lists 1-4, a document of 74 pages showing, for multiple stocks, starting material, method of preparation, toxic component concentration, basis for the first safe dilution (FSD), acceptable amount, calculation method, references and first safe dilution.

Alongside others, ECHAMP submitted its comments on this list. Few comments from the associations were implemented. Exceptions were Phosphorus where the draft first safe dilution of D9 ended up as D8, due to a revised calculation based on permitted daily exposure (pde); for China rubra and Chinchona pubescens the lowest human recommended dose (LHRD) used for the calculation of the FSD has been increased in the final FSD list due to a change of the dosage recommendations of the Merck manual in the meantime. The latter is a good example how important it is that the literature used for the FSD calculation is actual, and that assessment reports are published and actualised periodically. ECHAMP has pointed out this issue several times. Otherwise, it remains the burden for the companies to convince individual agencies during registration procedures to accept more recent scientific data than those originally published in the FSD lists.

Nosodes

HMPWG has also adopted and published on its website two new documents on quality, the first giving specific Guidance on module 3.2.S for Nosodes providing additional clarification to the Notice to Applicants template, as part of the existing guidance on module 3. The second new document is an Overview of comments on Guidance for Nosodes, giving a summary of the comments received in the consultation on the first document. ECHAMP did not submit comments on this document.

Meeting report

The report of the HMPWG meeting in Berlin, May 2018 are also now available. It confirms that, in the absence of a chairperson, the group will continue to work with a secretariat, composed of representatives from six Member States, including Romania, as the upcoming EU presidency. It reports on the progress of a number of initiatives, including quality, first safe dilution, justified homeopathic use and nosodes.