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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

2 Approach taken by regulators in the UK The Medicines and Healthcare products Regulatory Agency regulates herbal medicines in the UK. 10 Directive 2004/24/EC introduced a registration scheme for traditional herbal medicines and requires herbal remedies sold over the counter in the UK to be registered. 2012/1916). Ethnopharmacol.

Marketing 103
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Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

Overall, while the proposed regulation on SoHO may present some challenges for ATMP developers, it is also expected to ultimately improve patient safety and thus build trust not only in ATMPs, but also among patients and healthcare providers, which could ultimately benefit ATMP developers in the long run. Cited 2023Mar].

Safety 75