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SCIENTIFIC VALIDATION OF PHYTOCHEMICALS
The increasing health awareness in society is also reflected in the trend towards self-medication. The underlying herbal medicine of OTC preparations is partly based on traditional medicine. For these phytopharmaceuticals, a simplified procedure of "registration as a traditional medicinal product" is possible, in which the European Medicines Agency (EMA) recognizes many years of use as proof – clinical or bibliographic proof of efficacy is not required. For botanicals in foods and food supplements, on the other hand, stricter requirements apply: Here, scientific evidence of efficacy and safety must be provided.
Scientific evaluation and bioavailability
Various in vitro and ex vivo methods can prove the active potential of many botanicals. Bioavailability can also be tested using, for example, the CaCo-2 intestinal model or an organotypic model of the small intestine. The influence of accompanying substances (penetration enhancers) can be tested at the same time. Biotesys adapts the assays depending on the issue at hand.
Preparation for future quality requirements: Nutrivigilance
The introduction of nutrivigilance systems – monitoring concepts for the safety of nutritional products and botanicals based on pharmacovigilance – is currently being discussed in the EU. Although there is still no legal basis, discussions point to increased requirements for raw material quality, cultivation, logistics and processing in the future.
As the adaptation of existing processes will be time-consuming and cost-intensive, we recommend early preparation: establishing risk-based quality assurance, batch-to-batch controls and complete documentation along the supply chain. Biotesys supports you in future-proofing your systems.