A new publication, by AESGP experts in the September 2024 issue of Thieme’s Planta Medica, emphasizes the need for standardised information on herbal products to ensure robust real-world evidence (RWE) studies, and accurate regulatory conclusions.
Real-world data (RWD) are becoming increasingly relevant for assessing the real use, safety and effectiveness of medicines, including non-prescription medicines and herbal medicinal products. However, when it comes to herbal medicines, there are challenges limiting the potential of RWD in the regulatory field. Although there is a considerable amount of literature on the use of herbals, some information gaps on the description of the category and quality of the herbal ingredients makes it very difficult to make a sound analysis and conclusion. The absence of official standards on how herbal preparations and herbal medicinal products should be described in scientific publications, registries and databases is a major limitation for robust analysis of data.
Key Recommendations
To leverage RWD in regulatory decision-making for herbal medicinal products, it is essential to have accurate descriptions of herbal substances and preparations.
Standard information should include:
- Essential data on herbal ingredients (e.g. Latin names, types and quantity of the herbal preparation used), to ensure clarity and accuracy in scientific publications.
- A correct description of the finished product with its dosage form, posology, and indication.
- Information on the regulatory category of the herbal products (herbal medicinal products, food supplements, medical devices, cosmetics, non-registered products), as they may fall under different legislations with different requirements, notably on quality criteria.
Global guidelines for the correct description of herbals in articles, publications, databases, and registries should be promoted. Ensuring that data on herbal products is of sufficient quality and contains a minimum of information would be a game-changer for regulatory activities, academia, healthcare professionals and industry, and would unleash the possibilities offered by RWE, to the benefit of the patient.
Document
The full article can be freely accessed in the September 2024 issue of Planta Medica.
For more information on the article, please visit this page.