EN PL

GMP: New EMA/HMPC Reflection Paper on Stability of Herbal Medicinal Products

24.02.2011
This reflection paper addresses the need for specific requirements for establishing the stability of herbal medicinal products (HMPs). The quality, including the stability, of HMPs should be guaranteed and demonstrated in accordance with the existing requirements as set out in Annex I of Directive 2001/83/EC, as amended, Annex I of Directive 2001/82/EC, as amended and with current EU/ICH guidance on quality. The committees of the European Medicines Agency have published several quality guidelines related to stability testing, which focus mainly on chemically defined substances. In view of the complex nature of HMPs, it is considered that further guidance is needed in order to ensure that stability of these products is addressed appropriately. The purpose of this reflection paper is to consider issues relating to the application of the existing stability guidance on HMPs and to provide additional guidance where necessary.