Can RWD support Medical Cannabis Evalution?

The EMA has published the minutes of the meeting of the Committee for Herbal Medicinal Products (HMPC) held from 20-22 January 2025. The minutes include the report of the discussion on real world data (RWD) studies on cannabis flos.

HMPC work plan for 2025

During the meeting, the HMPC work plan for 2025 was presented, focusing on various topics such as

• RWD (e.g., establishing principles for the role of RWD in supporting EU herbal monographs),
• Collaboration with the Pharmacovigilance Risk Assessment Committee (PRAC),
• Improvement of public communication (e.g., clear communication with patients and healthcare professionals),
• Increasing training and work sharing (e.g., importance of internal training and collaboration initiatives to support new assessors / experts).

RWD studies on Cannabis flos

The HMPC members noted the final DARWIN EU study reports received relating to the RWD studies on Cannabis flos. A proposal was made to establish an HMPC/TDA-RWE liaison group, whose expertise could help identify future opportunities to fill knowledge gaps related to the HMPC work that could be addressed by the DARWIN EU studies. Different views were expressed on the following issues:

• To what extent did the study report answer the initial research questions?
• For what types of HMPC questions can DARWIN RWD studies add value, despite the current limitations of searchable databases?
• Proposals for DARWIN EU studies to be submitted in 2025.
• Principles for the scientific and regulatory use of RWD in the development / revision of EU herbal monographs.

Some HMPC members pointed out that, in practice, the DARWIN pilot study carried out in 2024 did not add any new information, but only confirmed what was already included in the HMPC's assessments. On the other hand, the limitations of EU databases with data on HMPs (OTC vs. prescription products) were highlighted and in this respect, it is advisable to have more different and searchable databases.

More information is available on the EMA's Committee on Herbal Medicinal Products (HMPC) website under "HMPC minutes".