The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received 68 applications to register products under the traditional herbal registration scheme implemented in line with the requirements of Directive 2004/24/EC. 31 registrations have been granted and the remaining 37 applications are under assessment. To date no applications have been refused.
A wide range of European guidelines is available for industry, for example on meeting the relevant quality and manufacturing standards. We recognise that moving from a largely unregulated environment into systematic medicines regulation represents a significant challenge for parts of the over-the-counter herbal medicines sector. Accordingly, the MHRA has been running a programme to manage the regulatory impact of the directive. This includes the opportunity for individual companies seeking to progress applications to register products under the scheme to be given regulatory and scientific advice. Our expectation is that, as with any such new scheme, with growing experience an increasing range of companies will become confident in operating under these regulatory arrangements.