On 1 September 2016, the European Medicines Agency (“EMA”) opened for public consultation a Draft revision to its Guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinal products. The consultation deadline for this Draft revision is 30 November 2016.

Background

The Draft revision substantially updates the Guideline which was initially published in 2006. With this revision, EMA looks to update the document to current standards taking into account the advances over the last 10 years, along with established practice and legal interpretations. Indeed, up to now the EMA mirrored developments in the assessment methodology mainly through template revisions (such as the Assessment report template) or through other documents such as public statement EMA/HMPC/473587/2011.

The revision to the Guideline on Herbal Medicines also aims to improve clarity and transparency of the assessment process related to medicinal products. It does so by reducing some sections and providing more details on some aspects, such as the specific patient populations whose situation should be addressed in assessing well-established and traditional herbal medicinal products.

The Guideline is intended to give advice for assessing data on well-established and traditional herbal medicinal products and the corresponding herbal substances/preparations in the framework of drafting EU monographs or the EU list.

Clinical Safety

The Guidance requires that, for traditional herbal medicinal products, evidence of widespread, long-standing use without significant safety problems be provided. In this context, lack of available information should be clearly identified. The fact that a product has long become obsolete could raise the question as to whether this is due to safety concerns.

Therapeutic Indications

According to the Guidance document, while there are no restrictions on the indications for well-established herbal medicinal products, there are a few concerns regarding traditional herbal medicinal products.

In principle, all indications that can be considered safe for the user without medical supervision are possible. However the Guidance states that therapeutic indications that are too general or that might be considered misleading, such as “promotion of good health” or “to give general strength”, are not acceptable. Also indications based on clinical parameters such as, i.e., the cholesterol level or the blood pressure require robust scientific data and are not considered appropriate for that reason.

Overall, the Guidance emphasises that clear indication should be given of the well-documented, consistent and long-standing use spread over at least 30/15 years for an indication concerning traditional herbal medicinal products to be accepted.

For further information visit: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/09/WC500212240.pdf