Update on Quality Topics for Herbal Drugs

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

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

Quality Topics to be started in 2022

• Guideline on Good Agricultural and Collection Practice (GACP) of starting materials of herbal origin:
  A concept paper on GACP revision has already been published. Following this, the HMPC will start drafting the revised GACP guideline taking into account responses received on the concept paper and publish the draft GACP guideline then for consultation.
  
  
• Questions & Answers (Q&As) on Quality of HMPs 
  The HMPC will remove Q&As now addressed in revised guidelines and add new ones collected / answered during past HMPC assessors’ trainings and meetings (e.g. on Elemental Impurities in HMPs, Skip Testing, Stability, GACP / GMP, Assay and Microbiological Issues).
  
  
• Guidance on New Manufacturing Techniques
  A reflection paper is being developed addressing the absence of guidance on, for example, supercritical CO2-extracts.
  
  
• Guideline on Declaration of Herbal Substances and Herbal Preparations in HMPs 
  To elaborate on a more harmonized approach, a concept paper will be drafted for the revision of the guideline in response to new practices and experiences identified as well as new Ph. Eur. and EMA quality standards / guidelines.
  
  
• Reflection Paper on Markers used for Quantitative and Qualitative Analysis of HMPs
  The HMPC will review Ph. Eur. definitions and HMPC monographs / assessment reports taking into account regulatory practice and different views on the role of active and analytical markers. A discussion paper is being drafted with proposals for better definitions considering existing Ph. Eur. defined extract types (particularly quantified extracts).

In addition, the HMPC announced to start with some activities relating to medical cannabis.

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