EMA: Phytotherapy drugs in Europe
The European Medicines Agency has published a report in which it reports on the current status of approvals and registrations of herbal medicinal products in Europe. Accordingly, Germany is a leader in the approval and registration of phytotherapeutic agents.
The Committee for Herbal Medicines (HMPC) at the European Medicines Agency (EMA) develops the European harmonized monographs (Community Herbal Monographs), which form the basis for the approval and registration of phytopharmaceuticals in Europe. Around 160 of these monographs are currently available.
According to the current EMA report, a total of 1577 traditional registrations have been issued between the introduction of the traditional herbal medicinal product registration process in 2004 and the end of 2015. The number of registrations from 2012 to 2015 was between 75 and 100 per year. Germany leads the statistics with 278 approvals and 263 registrations, whereby the preparations are approved much more frequently in Germany than in other European countries.
In the "traditional" registrations, devil's claw, pelargonium and valerian roots come first. Ginkgo, ivy leaves, St. John's wort and valerian root top the list of approved herbal monopreparations. Combination drugs are significantly more common in registrations than in approvals.
Regardless of whether registered or approved, there are no differences in the indications: cough and cold, stress and mood swings, gastrointestinal complaints as well as disorders of the bladder function or gynecological complaints rank among the five most common symptoms.
“Danger” may threaten phytos in some countries from the food sector. Because in some countries the products are placed as food supplements in the food sector, which is less strongly regulated than the pharmaceutical sector. You can find the investigation here.