HMPWG – consultation and updates

Some new documents have been uploaded onto the website of the Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Medicines Agencies.

• Two draft Questions and Answer documents on quality have been released for consultation  – Q 9 on GMP provisions and Q 13 on Stability. ECHAMP will be responding to this HMPWG consultation. Members are invited to submit their comments to office@echamp.eu by 25 March. 
• The Guidance on non‐clinical documentation in applications for registration of homeopathic medicinal products for human use has now been finalised and adopted by HMPWG. The overview of comments received on the draft document has also been published. ECHAMP members have developed deep knowledge on this topic and have been following it very closely. In our comments on the draft version of this guidance document, ECHAMP submitted proposals from industry associations and scientists for a more adequate calculation of acceptable amounts of toxicologically relevant ingredients according to recent scientific practice. We see no reason to treat homeopathic medicinal products more strictly than other medicinal products. These proposals have not been taken fully into consideration in this document. 
• The Report of the 33^rd meeting of HMPWG (virtual meeting) is now available. This was organised under the Slovenian Presidency by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP). Representatives from 17 EU member states attended plus representatives from Switzerland, EMA, EDQM and veterinary HMPWG/CMDv.