14/15 June 2021
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.
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:
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.
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.
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.
The following documents shall be finalized in 2021: