Phytotherapy refers to the medical use of plants, parts of plants, or preparations made from them for the treatment or prevention of diseases. If such substances are placed on the market as medicinal products, the pharmaceutical law requirements for quality, safety, efficacy, and product information apply. The herbal origin does not replace a regulatory assessment.
Herbal medicinal products and the role of the HMPC
Herbal medicinal products can contain herbal substances or herbal preparations as active substances. Preparations are created, for example, by extraction, distillation, expression, fractionation, purification, concentration, or fermentation. An extract is frequently a complex mixture; its description and quality control must therefore consider the starting herbal substance, the manufacturing process, and the relevant specifications. Consistent quality and a justified benefit-risk ratio are also required for herbal medicinal products.
The EMA’s Committee on Herbal Medicinal Products, HMPC, establishes EU herbal monographs and works on EU list entries. The monographs contain scientific assessments on medical use, target groups, and safe conditions of use. They can contain a section on well-established medical use and a section on traditional use. National authorities consult them when reviewing marketing authorizations or registrations; the concrete submission of many herbal medicinal products, however, occurs within the national framework.
Three European pathways: full application, well-established use and traditional registration
Firstly, a company can submit a stand-alone or mixed application under Article 8(3) of Directive 2001/83/EC. This pathway corresponds to the full application: safety and efficacy are proven with the company’s own non-clinical and clinical data or with a permissible combination of its own data and bibliographic information. It is relevant for products where the existing literature or traditional use is insufficient for the requested indication.
Secondly, Article 10a allows for marketing authorization based on well-established medical use, frequently referred to as well-established use. This requires that the active substances have had a well-established medical use within the Union for at least ten years, with recognized efficacy and an acceptable level of safety. The evidence predominantly relies on scientific literature. The quality of the specific product nonetheless remains to be fully proven; literature on a herbal preparation is only transferrable if the comparability of the preparation is convincingly shown.
Thirdly, Article 16a opens a simplified registration procedure for traditional herbal medicinal products. It requires bibliographic or expert evidence of a medical use of the product or a corresponding product for at least thirty years, of which at least fifteen years in the Union. Instead of the company’s own clinical efficacy studies, sufficient safety data and a plausible efficacy based on long-standing use must be available. The product must be intended for use without medical supervision and must not be administered by injection.
Differentiation from food supplements
Phytotherapy describes a therapeutic application and is not synonymous with a food supplement. Whether a product is a medicinal product depends in particular on its presentation and function. A product that is intended for the treatment or prevention of a disease or is advertised accordingly can fall within the scope of pharmaceutical law. Herbal ingredients therefore do not automatically make a product a herbal medicinal product.
Food supplements serve to supplement the normal diet and are subject to a different regulatory framework. They do not receive a traditional medicinal product registration solely because of long-standing use. Conversely, a traditional registration is no confirmation that every herbal preparation with a comparable name or the same plant is safe and effective. Product, preparation, dose, indication, and the respectively proven use are decisive.
Relevance for clinical trials
For the development of herbal medicinal products, the connection between the investigational medicinal product and the evidence is particularly important. In the case of complex extracts, differences in plant species, plant part, solvent, extraction ratio, or strength can influence the transferability of published data. Clinical trials must unambiguously describe the investigated preparation and have endpoints, target population, and safety monitoring that fit the requested indication. For a full application, a dedicated clinical program may be required, while literature and traditional pathways raise other evidence questions.
Full-service CROs such as Mediconomics support regulatory classification, study planning, investigational medicinal product documentation, site management, monitoring, data management, safety monitoring, biostatistics, and medical writing. In this way, quality data, clinical evidence, and the reference to HMPC monographs or literature can be combined such that the chosen marketing authorization or registration pathway is traceably justified.
Frequently Asked Questions (FAQ)
Are traditional herbal medicinal products authorized?
They are registered under a simplified procedure according to Article 16a. The registration differs from a marketing authorization based on full clinical data.
Is an HMPC monograph sufficient for any product with the same plant?
No. The applicant must show that the specific preparation and use are comparable to the assessed monograph.
Is a herbal food supplement automatically a phytotherapeutic?
No. Food supplements and medicinal products are subject to different legal frameworks; the classification depends on the product and intended purpose.
Regulatory references
- Directive 2001/83/EC, Article 8(3) — basis for the stand-alone or mixed marketing authorization application.
- Directive 2001/83/EC, Article 10a — regulates well-established medical use.
- Directive 2001/83/EC, Articles 16a to 16h — regulate traditional registration and HMPC tasks.
- EMA/HMPC EU herbal monographs — contain scientific assessments on use and safety.