Drug Regulators, MHRA, publish updated guidance on advertising traditional herbal medicines.

The guidance is intended for advertisers of traditional herbal medicinal products (THMs) holding a registration certificate granted by the MHRA under the Traditional Herbal Medicines Registration Scheme. This is the Scheme that implements the requirements of the Traditional Herbal Medicines Directive (Directive 2004/24/EC). Products registered under this Scheme must meet established standards of safety and quality for medicines but, instead of the recognised efficacy standards required for a marketing authorisation, the product must have been used for at least 30 years (at least 15 of which must normally have been within the EU) to demonstrate long-standing traditional use in the specified conditions of use.

General Statement

It is a central feature of the traditional herbal medicine registration scheme that the products concerned do not fulfil the requirement to demonstrate efficacy for a marketing authorisation. In particular, such products will not fulfil the efficacy requirements for a well-established medicinal use. There is one additional requirement for advertising of these products, to include a specified form of wording to inform the consumer that the efficacy of the product for the stated indications is not scientifically supported but is based exclusively on evidence of long-standing use.

“Traditional herbal medicinal product for use in [specify one or more indications for the product consistent with the terms of the registration] exclusively based upon long-standing use as a traditional remedy”.

The exact wording above must be used (with the italic section completed with appropriate indication(s) for use of the product).

Indication Statement

Advertisements must include at least one indication for use of the product. Wordings that imply efficacy has been demonstrated such as “clinically proven”, “effective for …” or “works fast to relieve …” are unlikely to be acceptable.

Reference to Clinical Trials

In order to ensure that consumers are not misled when presenting the results of limited clinical studies, it is important to make clear the basis on which the product was registered, i.e. that there were insufficient clinical data to demonstrate the efficacy of the product. In practice, given the nature of the traditional herbal scheme, it would be particularly difficult, in brief advertisements, to make reference to clinical trial data without misleading consumers. In principle it may be more feasible that compliance with the regulatory requirements may be achievable in a longer, more narrative type of advertisement (‘advertorial’), but the practicalities of this would need careful consideration.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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