Homeopathic medicinal products: an Update

Transcription

1 Homeopathic medicinal products: an Update Mag. Dr. Astrid Obmann Expert Group Herbal Medicinal Products & Homeopathics AGES-Gespräch Homeopathics: an Update Vienna, Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH Overview News from the Homeopathic Medicinal Products Working Group () News from the EDQM - Homoeopathic Raw Materials and Stocks () - Homoeopathic Manufacturing Methods Working Party (HMM WP) News from the German Homoeopathic Pharmacopoeia (GHP/HAB) 2 Working group of the HMA Dedicated to homeopathic medicinal products for human and veterinary use Representatives from the NCAs + Veterinarian 3 1

2 Last Meeting: Rome - Interesting Topics: oelection of a new chair o Interpretation of the term administered externally in the context of registrations according to Art. 14 of Dir 2001/83/EC as amended o Justification of homeopathic use oimpact of heat treatment on stocks o First safe dilutions o Viral safety o Subworking group on quality o Microbiological quality Next Meeting: Strasbourg 4 Election of a new chair - Biancamaria Bruno (IT) Interpretation of the term administered externally in the context of Art. 14 registrations - Request of the European Commission - Definition to be included in the NtA - Draft Letter to EC Justification of Homeopathic Use - Second List of stocks adopted - Discussion on nomenclature ( Titles used in homoeopathy, Pharmeuropa 16.4) 5 Impact of heat treatment on stocks - Outcome of discussion: Safety first First safe dilutions - Assessment is a complex procedure - Limited resources in member states - Existing process should be improved, each member state should contribute - Comments from public consultation to be discussed in the sub working group 6 2

3 Viral safety - Revision of the Points to consider on Safety of Homeopathic Medicinal Products from biological origin - Public consultation until Overview of comments to be presented at the next -Meeting Sub working group on quality - First discussion - Chair? 7 Microbiological quality - How should limits given in Ph. Eur. be applied to raw material, stocks, dilutions and finished product? - Presentation of a draft-decision tree - Next meeting: first draft on points to consider to be presented 8 Working party of the EDQM Development of individual Ph. Eur. monographs for homeopathic raw materials and stocks So far 24 monographs included (Ph. Eur. 8.5) Very slow progress due to complex procedure and extensive discussions So far priority list only for potentially toxic preparations 9 3

4 New Monographs (Ph. Eur. 8.3) - Homoeopathic pillules, coated (2786) - Agaricus phalloides for homoeopathic preparations (2290) - Ignatia for homoeopathic preparations (2513) - Nux-vomica for homoeopathic preparations (2514) 10 Points for discussions - Assay: o Mandatory for potentially toxic herbal substances, e.g. Nux-vomica for homoeopathic preparations (2514) o Non-toxic substances? E.g. Allium sativum for homoeopathic preparations (2023) 11 Nomenclature - From Standard Ph. Eur. wording back to Traditional homoeopathic names - e.g Allium sativum - AT: Nomenclature according to currently valid GHP- Monographs 12 4

5 Structure of the monographs changes - e.g. Nux-vomica for homoeopathic preparations o Identification: Microscopic examination (Test B) with illustrations o Mother tinctures: more detailed description of production methods compared to older monographs 13 Outlook - Priority list for non-toxic preparations o Survey among Member States ( Most important preparations ) - General Monograph on minerals for homoeopathic use shall be added to work programme 14 HMM WP Working party of the EDQM Development and improvement of the monograph Methods of preparation of homoeopathic stocks and potentisation - Methods from German Homoeopathic Pharmacopoeia and French Pharmacopoeia to be integrated in Ph. Eur. Development and improvement of other general monographs 15 5

6 HMM WP Current work programme - Integration of GHP methods Microbiological quality (Ph. Eur , 5.1.8) o See planned Points to consider - Revision: o Homoeopathic pillules, impregnated (2079) o Methods of preparation of homoeopathic stocks and potentisation (2371) 16 GHP 2014 New texts - Monographs o Amanita muscaria o Humulus lupulus ferm 34d - Other texts oreagents o Raw material Revised texts - Monographs (e.g. Bryonia) o Omission of wet chemical analysis for identification o In general identification preferably by TLC o Addition of an assay (preferably by HPLC) 17 GHP 2014 Revised texts - Methods of preparation (Method 21, 22, 28) o Precision of wording - Reagents - Carriers and excipients o Yeast : change of storage conditions Corrected texts - Only monographs - In most cases editorial changes 18 6