The EMA Committee on Herbal Medicinal Products (HMPC) published the minutes for their meeting held on 16-18 May 2022. The Meeting Protocol contains several interesting developments regarding Cannabis.
Updates regarding Medical Cannabis
The meeting Protocol provides the following information relating to Cannabis:
European Pharmacopoeia (Ph. Eur.) Monograph for Cannabis Flower: The work on the establishment of a Ph. Eur. monograph for Cannabis flos (3028) is ongoing. The next meeting of the EDQM Expert Group 13B, who is responsible for the monograph elaboration, will be held in September 2022.
In a response from DG Santeit has been noted that well-established usewithin the EU "for at least 10 years, with recognized efficacy and an acceptable level of safety based on bibliographic data, is not unlikely". However, the registration of cannabis-based medicines as traditional herbal medicines is not likely. In addition, during the meeting, DG SANTE pointed to the "heterogenicity of cannabis-based products in the EU, with a great diversity in composition, quality and in legal status".
An (internal) draft Q&A document has been developed. Rapporteurs were invited to modify the draft Q&A, in particular regarding: - Cross-references to various documents to be introduced (e.g. to the Cannabis Glossary); - Comments from EMA Regulatory Affairs Office (additional national requirements due to the nature of the active substance or requirements for agriculture fall outside of the Q&A); - Comments from DG SANTE that the document’s scope should be clear to avoid any risk of confusion between HMPC monographs and Ph. Eur. monographs.
EU herbal monograph for Cannabis flos: It was highlighted that regarding the ‘collaboration with EC on the feasibility to establish an EU herbal monograph for Cannabis flos’, the HMPC cannot conclude on such feasibility before receiving data from interested parties (thus public consultation on the Q&A document is required).