Manufacturing processes for homeopathic and anthroposophic medicinal products are standardised in the European Pharmacopoeia (Ph. Eur.) and in specific national Pharmacopoeias, such as Pharmacopée Francaise (Ph. Fr.) or the German Homeopathic Pharmacopoeia (HAB).
- Quality standards are important, as they bring recognition and help to create a legal framework for homeopathic and anthroposophic medicinal products. This gives a solid basis on which to submit dossiers for a marketing authorisation or registration, and gives the authorities a legal instrument by which to review the quality.
Europe is the centre of pharmaceutical expertise in these products. The pharmaceutical processes, including quality monographs for both starting materials and manufacturing methods, are developed in the industry, further developed with academics and confirmed by regulation. ECHAMP and its members work hard to achieve feasible and coherent standards with the different quality traditions of homeopathic and anthroposophic medicinal products in Europe.
European Pharmacopoeia (Ph. Eur.)
- This provides official standards for the manufacture and quality control of medicinal products in all its signatory states. It seeks to standardise process for the manufacture of homeopathic medicinal products through the Homoeopathic Manufacturing Methods Working Party (HMM WP) and the Homoeopathic Working Party (HOM WP), which elaborates monographs on the substances used in homeopathic preparations.
Anthroposophic Pharmaceutical Codex (APC)
- The APC describes the main anthroposophic manufacturing methods not described in any official pharmacopoeia of the EU Member States, although they are included in the Pharmacopoeia Helvetica. It also describes the substances used in anthroposophic medicine, referencing to other Pharmacopoeia where possible. The third edition of the APC was published in 2014.
The Pharmacopoeia Helvetica contains two monographs on anthroposophic medicinal products: one general monograph on anthroposophic preparations and one special monograph describing all relevant anthroposophic manufacturing methods, those following a homeopathic technology as well as those strictly specific to anthroposophic pharmacy.