Real-World Data Requirements for Herbal Medicinal Products

Real-world data (RWD) is becoming increasingly relevant for evaluating the safety and effectiveness of medicinal products, including non-prescription medicines and herbal medicinal products (HMPs). In order to use RWD for regulatory decision-making in the field of HMPs, it is crucial to have an accurate description of the herbal drugs and preparations, as herbal medicinal products, in contrast to chemically defined medicinal products, contain a complex mixture of natural compounds.

A scientific article in the style of a white paper has been published in September 2024 in the journal Planta Medica. The paper on requirements for the description of herbal preparations included in real-world data (RWD) publications concludes that a precise description of herbal drugs, herbal drug preparations and HMPs is essential for the use of RWD for regulatory decisions.

Description of Herbal Drugs & Herbal Drug Preparations

The white paper provides a compact overview of the necessary information that should be included in scientific RWD publications on herbal medicinal products in order to generate comparable and high-quality data. According to the article, the following parameters should be specified to enable an appropriate description of herbal drugs / herbal drug preparations:

• Name of the used herbal drug in Latin and, optionally, English.
• Type of the herbal drug preparation (e.g., dry extract, tincture).
• Quantity of the (genuine) herbal drug preparation.
• Drug extract ratio (DER genuine) or equivalent quantity of the herbal drug (as a range), 
• Name and composition of the extraction solvent(s).

The complete Planta Medica article "Basic Requirements and Framework Conditions of Real-World Data (RWD) on Herbal Medicinal Products" can be found on the Thieme publisher website.