Stability testing of herbal medicinal products and traditional herbal medicinal products - Scientific guideline

This document addresses the challenges of evaluating the stability of herbal medicinal products (HMPs). It considers issues relating to the application of the existing stability guidance on HMPs and provides additional guidance where necessary.

Keywords: Herbal medicinal products, traditional herbal medicinal products, herbal substances, herbal preparations, extracts, quality, stability

Current version

Reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products

Adopted Reference Number: EMA/HMPC/3626/2009 Summary:

This reflection paper addresses the need for specific requirements for establishing the stability of herbal medicinal products (HMPs).

Document history - First version (current)

Reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products

Adopted Reference Number: EMA/HMPC/3626/2009 Summary:

This reflection paper addresses the need for specific requirements for establishing the stability of herbal medicinal products (HMPs).

Overview of comments received on draft reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products

Reference Number: EMA/HMPC/5873/2010

Draft reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products

Draft: consultation closed Reference Number: EMEA/HMPC/3626/2009