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DOI: 10.1055/a-2409-3125
Basic Requirements and Framework Conditions of Real-World Data (RWD) on Herbal Medicinal Products
The authors are grateful to the AESGP working group focusing on real-world data of 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.
Publication History
Received: 02 July 2024
Accepted after revision: 06 August 2024
Article published online:
25 September 2024
© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
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