Devil’s claw is the sixth botanical extract to join the short list of herbal drugs with Certification of Suitability to the monographs of the European Pharmacopoeia (CEP). By granting this certification, the European Directorate for the Quality of Medicines & Health Care (EDQM) recognises that Naturex’s devil’s claw extract is safe and fully compliant with the European Pharmacopoeia tests and specifications. As a prerequisite of the dossier, the manufacturing site operates under full pharmaceutical GMP (ICH Q7).
“Being granted the first ever CEP certification for a devil’s claw extract is a fitting acknowledgement of the extensive work of our teams during the rigorous registration process,” stated Pierfrancesco Nannipieri, Global Pharmaceutical Regulatory Affairs Manager.
“Beyond the compliance of the devil’s claw extract with the European Pharmacopoeia, this certification will fully benefit our customers,” said Maxime Angelucci, Head of Sales for Europe and Africa. “The CEP is widely accepted and helps to shorten the time-to-market for new drug developments because the API receives immediate approval. This removes a number of constraints for the client, as an individual assessment of the API by each national authority is no longer necessary.
“Moreover, the CEP is not only relevant to the EU member states. A growing number of authorities acknowledge this certification as part of an expedited registration process in countries such as Canada, Australia, New Zealand, Tunisia,and Morocco.”
According to the monograph on harpagophytum procumbens from the European Medicines Agency, certain therapeutic indications are permitted for CEP-certified devil’s claw. For example, companies may promote it as a ‘traditional herbal medicinal product for relief of minor articular pain’.
This certificate is a good complement to Naturex’s collection of over 30 APIs approved for sale in Europe.