The Reflection Paper on Stability Testing of Herbal Medicinal Products and Traditional Herbal Medicinal Products (EMA/HMPC/3626/2009) was published on the 21st of October 2010.
The EMA has published several quality guidelines related to stability testing. Those requirements mainly focus on chemically defined substances. Herbal medicinal products and traditional herbal medicinal products, however, have a number of characteristics which differentiate them from drugs with chemically defined substances. Among other things, chromatographic fingerprints and the use of marker substances for methods of assay are recommended.
That's why there is a need for specific stability guidelines in the phyto area.
The industry itself has huge interest in having stability guidance specific to Herbal Medicinal Products, in particular, on when to apply a reduced set of stability tests.
It has been agreed on the creation of a Q&A document concerning this guidance. The document is already available and entitled Questions & Answers on quality of herbal medicinal products / traditional herbal medicinal products (EMA/HMPC/41500/2010).
At the moment, there are 12 Questions and Answers dedicated to the Stability subject. It is planned to add new Questions and Answers, if required.
You can find here the Reflection Paper and the Q&As .
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)