Language: English

The European Directive 2004/24/EC generated a new harmonised way for a simplified registration of Traditional Herbal Medicinal Products (THMP). Pan-European standards apply for products, which have been marketed heterogeneously within the member states often exempted from pharmaceutical authorisation procedures. Safety concerns are one driving force to regulate these classical borderline products. The “generally regarded as safe” conception is challenged by a number of adverse events associated with THMP over the last decade. Subsequently, European regulators initiated a framework of herbal medicine specific guidance in order to address quality and safety issues.
Considering the multiple complexities of HMP/THMP, adverse events of the past and current regulations are discussed in terms of general State of the Art and implications for manufacturers. For that, it is differentiated between intrinsic or extrinsic safety issues and further subdivided into herbal product specific quality related risks (identification, purity) and real toxicological risks. Related issues such as standardisation, patient information and pharmacovigilance are also considered.
The result is a patchwork of regulations, which are either transferable from other pharmaceuticals, or influenced by foodstuff legislation. In contrast, authentication and standardisation are highly HMP specific. Quality aspects -when implemented- are already well covered by European Pharmacopoeia standards, whereas other new challenges such as non-European traditional medicine require adaptation to a changing market and new technical opportunities. Extrinsic, quality related risks should be minimised to a demarcation issue in the future, whereas intrinsic risks can cause over-regulation mostly based on a poor data situations. In summary, the new European framework establishes a suitable quality/safety standard for THMP, but tremendous efforts in implementation and reduction to praxis are required in the majority of member states. In comparison to synthetic drugs, less restrictive standards and individual solutions will further dominate THMP regulation in order to find the balance between safety and the maintenance of a diverse market of affordable THMP.

Pages : 58