Traditional herbal registrations
Following on from my previous blog introducing herbal medicinal products (which you can find here), this blog is going to look deeper into the traditional herbal registration (THR) pathway and how it can be used.
What is the traditional herbal registration pathway?
In 2004 the EU and UK introduced a simplified registration route for getting herbal medicinal products to market. This is called a THR, and can be found in Regulation 127 of The Humans Medicines Regulation 2012 or EU Article 16a of Directive 2001/83/EC. This route allows for registration with a simplified dossier where products meet the relevant criteria. The aim of this route was to improve public safety, and remove unlicensed herbal medicines from the market.
Eligibility
To be eligible for this pathway, the active ingredients need to be solely of herbal origin. In addition, evidence must be provided to show that the product has been used traditionally to treat the condition for a minimum of 30 years. If your application is within the EU, at least 15 out of the 30 years must relate to use within the EU/EEA. For the UK, the MHRA may be able to accept 15 years from a wider range of countries in addition to the UK and EU. While the MHRA have not yet published which countries will be accepted, it is likely to be those which have a similar pharmacovigilance system to that of the UK.
Indications
There are restrictions on the indications permitted for a traditional herbal medicinal product. Firstly, the indication must correspond to the traditional use of the product. Secondly, the product (and therefore indication) must be designed for use without supervision from a medical practitioner. The majority of THRs are therefore general sales list (GSL) products. If you want your herbal medicinal product to have indications outside of this, or if it will be a prescription only product, you will need to make a full application as a medicinal product under Regulation 50 of the Humans Medicines Regulation 2012 (UK) or Article 8(3) of Directive 2001/83/EC (EU). As herbal medicines can have a wide range of uses and come in many forms, it is important to make sure that they are correctly classified before you make your application to the authorities.
Safety and quality requirements
Just like a standalone marketing authorisation, a dossier containing all of the safety and quality information must be provided in the electronic Common Technical Document (eCTD) format. This includes a full Module 3 containing all of the quality information on both the herbal substance and herbal preparation. The normal GMP requirements will also be applicable to the product.
To fulfil the safety requirements, Module 4 and 5 can be provided as a bibliographic review without the need for non-clinical and clinical trials. An expert report reviewing the safety data by a suitably qualified person also needs to accompany the application. EU herbal monographs and list entries can be used to help form a basis for the bibliographic information, and in some cases may even be able to be fully relied upon for all of the safety requirements.
If you would like to discuss how Fusion Pharma can support you with your traditional herbal registrations, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
