EMA's Q&A on Medicinal Cannabis & Call for Scientific Data

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The Committee on Herbal Medicinal Products (HMPC) adopted a Question & Answer (Q&A) document regarding Cannabis-derived medicinal products and the scope of EU herbal monographs for herbal medicinal products within the EU medicines legislation. The document aims to clarify the basic regulatory requirements for granting a marketing authorization for medicinal products in the EU for stakeholders that may not have extensive experience with the EU pharmaceutical regulatory system. The Q&A has been published on the Agency´s Herbal medicinal products: questions and answers website. The document clarifies amongst others that there is no specific framework for Cannabis-derived medicinal products in the EU. Products containing Cannabis that meet the definition of a (finished) medicinal product, must comply with the requirements of the EU pharmaceutical law, and must obtain a marketing authorization from a Competent Authority before they can be placed on the EU market, like any other medicinal product.

What is an EU herbal monograph?

According to the Q&A document, an EU herbal monograph contains the scientific opinion of the HMPC on safety and efficacy about a herbal drug and its preparations intended for medicinal use. The HMPC evaluates all available information, including non-clinical and clinical data, and also documented long-standing use and experience in the EU. The EU herbal monograph should not be confused with the Ph. Eur. Cannabis flos monograph (draft) that cover the quality requirements. Reference to established EU herbal monographs can be made in marketing authorization applications (e.g. for well-established use) and in traditional-use applications that are usually national procedures.

Call for Scientific Data

In order to establish an EU herbal monograph for Cannabis flos, the HMPC requests the submission of scientific evidence on Cannabis flos (cannabis flowers). Calls for data will be published in 3 waves to ease data collection and provision by Interested parties. The document Call for scientific data for use in HMPC assessment work on Cannabis sativa L., flos (Cannabis sativa flowering tops) is available at EMA´s Procedures for monograph and list entry establishment website. The submission period is 15 February to 14 May 2023.

Scientific contributions should be relevant exclusively to the medicinal use of Cannabis flos and herbal preparations thereof, and not of other Cannabis-derived products or substances like, for example, isolated constituents. "Due to the general high public interest in Cannabis-derived products beyond the medicinal framework, interested parties are reminded of the limited scope of this call for data", the agency says. The scope should therefore address either:

• Well-established use (WEU): Submitted data should provide evidence that the medicinal product has a well-established medicinal use for at least 10 years in the EU with recognized efficacy and an acceptable level of safety,

or

• Traditional use (TU):  Submitted data should provide evidence that the medicinal product (or a corresponding product), has been in medicinal use throughout a period of at least 30 years, including at least 15 years within the EU, is not administered via injection, and can be used without supervision of a healthcare professional.

More information is available in the HMPC meeting report on European Union herbal monographs, guidelines and other activities of the 109th HMPC meeting, held on 23-25 January 2023 published on EMA´s HMPC: Agendas, minutes and meeting reports website.