Traditional Herbal Medicinal Products Directive THMPD
The Traditional Herbal Medicinal Products Directive (THMPD) was established to provide a regulatory approval process for herbal medicines in the European Union (EU). Since 30 October 2005, herbal medicines in the EU / UK (http://www.mhra.gov.uk) are now controlled under the EU regulation, 2004/24/EC (Traditional Herbal Medicines Product Directive).
Under this regulation, a company needs to demonstrate the safety and efficacy of the herbal medicine through traditional use within the EU for at least 30 years (or 15 years within the EU and 15 years outside the EU). Further, the herbal medicine must be now manufactured under GMP (Good Manufacturing Practice), however, the Traditional Herbal Medicines Product Directive does allow claims to be made on the label of the final product, although restriction do apply.
Dr John Wilkinson's consultancy can evaluate and carry out the necessary analyses and advise on clinical trials of herbal medicine products; research, collate and write the dossier for submission to the MHRA (Medicines and Healthcare Products Regulatory Agency).
For evaluation we have three different stages to help companies decide if the Traditional Herbal Medicinal Products Directive THMPD route is likely to be successful or not and if appropriate, how to obtain regulatory approval.
1. Executive summary - Traditional Herbal Medicinal Products Directive THMPD
Dr John Wilkinson's consultancy will conduct a preliminary review of the product and make recommendations on whether to go ahead through the Traditional Herbal Medicinal Products Directive THMPD or whether an alternative regulatory route would be more appropriate. This often includes consultation with the appropriate regulatory body.
2. GAP analysis - Traditional Herbal Medicinal Products Directive THMPD
If the Traditional Herbal Medicinal Products Directive is a suitable route to approval and marketing authorisation, then the next step is to conduct a complete and thorough GAP analysis of the product to make sure all the necessary studies and analysis have been carried out and to the required standards. Any gaps found in the data will need to be supplied and Dr John Wilkinson's consultancy can undertake the laboratory work and associated studies on behalf of the client if necessary.
We also offer traditional uses searches to support 15 years of use in the EU and the much harder to find - 30 years of use globally. Our searches go way beyond the traditional use data found in the EU monographs and is the result of over 25 years of experience researching traditional use of herbal medicines and the phytochemicals found within them. We have a large specialist library plus specialist databases including our own extensive internal database plus access to "hard to find" trade magazines and access to sales invoices to support history of use. We also offer specialist reports on traditional use, which as experts in the field, can be used in their own right as "supporting data from experts" to partially or wholly fulfill the traditional use parts of the dossier and / or for product launches.
3. Submission of the dossier -Traditional Herbal Medicinal Products Directive THMPD
Finally, once the GAP analysis has been completed and any missing data has been generated, Dr John Wilkinson's consultancy will write the dossier and submit this to the MHRA in the UK or in other EU member states if required. We can also undertake submissions in Brazil and other parts of Latin America.
4. Approval of herbal medicines in the EU without history of use in the EU
We are exploring innovative ways in which we can help our clients get regulatory approval either within the THMP directive or via "specials", or Well Established Use (WEU) with herbal products that do not have 15 years of use in the EU or meet the 30/15 requirements.
This will be of interest to companies that manufacture herbal medicines that have a safe history of use in the country of origin such as China India, Japan, Africa countries, and South America and now want to sell these products in the EU. In certain circumstance it may also be possible to get approval through the Novel Foods Directive although a separate application will be needed to get any health claims approved that are associated with the product.
5. Strategic advice
We undertake alot of strategic work such as reviewing traditional uses or phytochemistry of a particular herb by using our specialist knowledge gleaned from working in the field for over 25 years. We are particularly good at finding "hard to get" traditional use data and can also applying this knowledge to stretching and creating, novel and unique medicinal claims under the THMPD.
We also gather and interpret competitor products from for example, reviewing "positioning" on pharmacy shelves in various countries, scientific and technical searches in the regulatory databases of the EU, USA and South America, bibliographic searches, producing reports on regulatory approved products from a global perspective; We also undertake specialist product searches in trade publications such as C & D and also conduct fast (same day/overnight) searches of old Pharmacopoeias, herbal monographs and out of print books. For example we have a copy of the classic herbal "Potters Cyclopedia" dating back to 1907 and many old herbal and herbal cosmetic books from the 1800's to the present day to help with traditional use and gathering information on old herbals and various commercial products.