Will there be an EU Herbal Monograph for Cannabis?

The Herbal Medicinal Products Committee (HMPC) published the HMPC Work plan for 2022. Amongst others, the HMPC plans several activities relating to regulatory requirements for medical cannabis.

Key Objectives and Activities in 2022 relating to Medical Cannabis

Due to global political and market developments in relation to the therapeutic use of medical cannabis products, EMA´s HMPC is often approached by the industry on regulatory questions with regard to market access and regulatory requirements / standards for herbal medicinal products (HMPs). The European Commission (EC) previously requested a compilation of terms and definitions ("Cannabis Glossary") but also suggested to check the possibility for an EU herbal monograph.

HMPCs key objectives & activities in 2022 relating to medical cannabis are the following:

  • Explore the feasibility to establish an EU herbal monograph for Cannabis flos and initiate first steps to clarify to the EC and the public the opportunities and limitations of the pharmaceutical legislative framework.
  • Establish specific Q&As providing some basic information regarding existing regulatory standard requirements for HMPs.
  • Publish a call for data tailored to the specific complexity of cannabis derived substances and medical cannabis on the EU market.
  • Establish a multidisciplinary group for the assessment.
  • Coordinate with the European Directorate for the Quality of Medicines (EDQM) to clarify the scope of specific Ph. Eur. Cannabis monographs in relation to possible EU herbal monographs as well as other EU institutions.
  • Coordinate with the Committee for Medicinal Products for Human Use (CHMP) and the Co-ordination group for Mutual recognition and Decentralized procedures – human (CMDh) for any issues related to cannabis-derived medicinal products.

In addition, the HMPC announced to start with some activities relating to other HMP quality topics.

More information is available in EMA´s Committee on Herbal Medicinal Products (HMPC): work plan 2022 published on the HMPC website.

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