The Committee on Herbal Medicinal Products (HMPC) is the European Medicines Agency’s (EMA) committee responsible for compiling and assessing scientific data on herbal substances, preparations and combinations, to support the harmonisation of the European market.
The Herbal Medicinal Products Committee (HMPC) published the HMPC Work plan for 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
- 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).
More information : HMPC website.