Herbal Drugs: Ph. Eur. Cannabis Monographs and other relevant Topics

Recommendation

5/6 June 2024

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

EMA´s Herbal Medicinal Products Committee (HMPC) released the minutes for the HMPC meeting held in November 2021. Amongst others, the HMPC noted three new Ph. Eur. Cannabis Monographs for flowers and extracts in the pipeline. Other relevant topics were nitrosamines, GACP revision, and elemental impurities in herbal medicinal products.

According to the minutes some documents mentioned cannot be released at present (e.g., the announced Concept paper on the revision of the GACP Guideline) as they are subject to ongoing procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents.

European Pharmacopoeia (Ph. Eur.) Cannabis Monographs to be elaborated

Currently, in the EU, there are only (non-harmonized) national pharmacopoeial monographs available for Cannabis Flower (e.g., DAB, Ph. Helv.) and Cannabis Extracts (DAB). Harmonized Ph. Eur. monographs for flowers and extracts would be very helpful in terms of equal EU quality requirements (e.g. regarding import / export). The HMPC noted the following three new Ph. Eur. Cannabis Monographs in the pipeline that could be of relevance:

• Cannabis flos (3028),
• Cannabis extractum siccum (3068),
• Cannabis extractum spissum (3069).

The draft Ph. Eur. Cannabis Monographs are expected to be published for public comment (once they have been elaborated) in Pharmeuropa.

In addition, a new USP (United States Pharmacopeia) monograph for Cannabidiol (CBD) is being developed. The proposed USP monograph has been published in Pharmacopeial Forum (PF) 48(1), January 2022. It defines that CBD is obtained from Cannabis sativa.

Other relevant topics

• Nitrosamines and HMPs
  The final Q&A on nitrosamines was adopted by the HMPC and it has already been published in the CMDh practical guidance. Although it was acknowledged that there might be herbal specific root causes not found in other medicinal products, it was agreed not to elaborate on these from a general perspective. According to the HMPC, there is currently "no specific knowledge available and the area is too complex that theoretical assumptions could be supported by specific data to allow any conclusions and an informed risk assessment". The HMPC may consider taking up this Q&A also in the herbal specific quality guidance (such as a Q&A revision).
  
  
• Good Agricultural and Collection Practice (GACP) of starting materials of herbal origin
  The HMPC adopted the Concept paper on the revision of the GACP Guideline. The members agreed on the need to revise the guideline from 2005. The scope of the guideline should be carefully considered during the revision in line with EU GMP Guide Annex 7 (Manufacture of Herbal Medicinal Products) and other relevant guidance documents as well as possible coordination with the Inspectors Working Party.
  
  
• Q&A on Elemental impurities - Evaluation in HMPs
  (Finished) herbal medicinal products (HMPs) are currently not included in the scope of the ICH Q3D Guideline on Elemental Impurities. However, limits for heavy metals in herbal drugs and extracts are provided, for example, in Ph. Eur. and USP general chapters. The HMPC agreed to draft a Q&A on elemental impurities in HMPs and welcomed this Q&A as a first step to revise the Herbal Quality Q&A.

For more information please see the Minutes of the HMPC 22-24 November 2021 meeting.