Cannabis Glossary and GACP Revision

Recommendation

6/7 June 2023

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

EMA´s Committee on Herbal Medicinal Products (HMPC) published the 2021 HMPC work plan. Amongst others the HMPC plans to establish a cannabis glossary and to revise the GACP guidelines.

Cannabis Glossary

The HMPC plans to establish a list of terms, definitions and standards related to the regulation of Cannabis-derived products for medicinal use. The list of definitions with expert comments will be the first step for an EU Herbal monograph for Cannabis flos. So far only national (non-harmonized) monographs exist (e.g. in Denmark, Germany, Switzerland). The next steps will include the following:

• Finalize an Inventory List of Terms and Definitions for Cannabis related products
• Coordinate with EDQM to clarify the scope of Ph. Eur. monographs in relation to possible EU herbal monographs and publish a call for data tailored to the complexity of cannabis derived substances
• Prepare specific Q&As for some basic information regarding the so called ‘medicinal cannabis’ regulation

The ECA Cannabis Working Group recently published the "ECA Cannabis Roadmap". The 100 pages document compiles global GMP and quality requirements together with regulatory information for Medicinal Cannabis (and CBD Products). In addition, it provides useful comments and an Annex with further information.

GACP Revision

Starting in 2021 the HMPC plans to revise the Guideline on Good Agricultural and Collection Practice (GACP). The goal is to draft a concept paper for revision to address stakeholder requests on required clarifications, e.g.

• overlap GMP vs. GACP,
• uncertainty about requirements,
• GACP certification and dossier,
• comparison to other GACP standards such as WHO.

In addition, the Questions & Answers on quality of herbal medicinal products will be revised in order to remove Q&As now addressed in other guidelines and add new ones (incl. on skip testing, stability, GACP / GMP, assay and microbiological issues).

The EMA recently already clarified the GMP requirements for herbal substances used as APIs.

Other Quality Guidelines

The following documents shall be finalized in 2021:

• Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination with PAs
• Revision of the Guideline on quality of herbal medicinal products
• Revision of the Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and HMP/THMPs

For more information please read the HMPC 2021 work plan on EMA´s HMPC website.