Steinhoff, Barbara. European Scientific Cooperative for Phytotherapy (ESCOP); German Society for Phytotherapy (GPT)
Ponencia en el 13º Congreso de Fitoterapia de SEFIT. Barcelona, 6-9 de noviembre de 2025
Herbal medicinal products (HMP) are firmly anchored in the European legal framework. Like for all other medicinal products, the general precondition for marketing HMP is the regulatory review by health authorities including the proof of efficacy, safety and quality. The main tasks of the Committee on Herbal Medicinal Products (HMPC) at the EMA consist in the creation of guidance documents and of European Union Monographs for the following areas:
Well-established medicinal use (for marketing authorisation): products with a medicinal use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety; whereas preclinical and clinical testing are normally replaced by appropriate scientific literature
Traditional use (for registrations): products with a medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community; proven safety; oral/external/inhalation; self-medication indications
One of the currently problems in HMPC monographs is the regulatory restriction of use of HMPs to persons from 12 or even 18 years of age onwards, due to the lack of sufficient data in children and adolescents. Another current topic is the assessment of estragole-containing HMPs by health authorities, following an HMPC statement that includes a guidance value of 0.05 mg estragole/person per day for adults and adolescents and further restrictions for sensitive patient groups. In order to reach or come as close as possible to this guidance value, the lowest dose should be consistently selected if ranges of doses are available.
With regard to quality assurance and the implementation of the principles of Good Manufacturing Practice (GMP) into the production of HMPs, specific guidance (Good Agricultural and Collection Practice, GACP) is available for initial process steps of starting materials of herbal origin where GMP rules are not directly applicable (“in the field”), with the objective of ensuring a high and consistent quality and identification of critical steps. For quality control, HMPs and their starting materials and active substances make reference to the respective monographs of the European Pharmacopoeia, and further guidance is given in a number of HMPC guidelines. As HMPs are produced using medicinal plants from natural origin, additional tests for residues or contaminants, respectively, are performed, including plant protection products, heavy metals, pyrrolizidine alkaloids (PA) etc.
