Basic Requirements and Framework Conditions of Real-World Data (RWD) on Herbal Medicinal Products.

Abstract

Real-world data (RWD) is becoming increasingly relevant for evaluating safety and effectiveness of medicinal products, including non-prescription medicines and herbal medicinal products in particular. In order to use real-world data for regulatory decision-making in the field of herbal medicinal products, it is crucial to have an accurate description the herbal substances and preparations, as herbal medicinal products, in contrast to chemically defined medicinal products, contain a complex mixture of natural compounds. However, it remains challenging to get standardised information on herbal products from current literature. This publication gives a brief overview of necessary information of herbal medicinal products in scientific literature and data sources to ensure high-quality real-world data.