EMA Reflection Paper on Safety Signals for Herbal Medicinal Products

Recently, the Committee on Herbal Medicinal Products (HMPC) together with EMA's Pharmacovigilance Risk Assessment Committee (PRAC) published a draft reflection paper on particulars for safety signals for herbal medicinal products (HMPs). The deadline for comments is 15 October 2026.

Background and Aspects to be considered

Currently, there are no particular considerations mentioned regarding HMPs in the relevant EU guidelines (e.g., GVP Module IX – "Signal management"). Therefore, the reflection paper discusses particular aspects to be considered for safety signals for HMPs in addition to the established EMA guidance documents. The paper should be read in conjunction with Directive 2001/83/EC, Regulation (EC) No 726/2004 and Commission Implementing Regulation (EU) No 520/2012, as well as other relevant GVP guidelines. The EU Guideline on Good Pharmacovigilance Practices (GVP - EudraLex Volume 9) is the principal guidance supporting implementation of, and compliance with, legal requirements.

In particular, the following aspects should be considered for safety signals for HMPs:

• The underreporting of suspected adverse reactions for HMPs.
• Generally very limited information available on the HMP involved in a suspected adverse reaction.
• The quality of products of herbal origin, including the botanical identification and phytochemical characteristics of herbal substances/preparations, is correlated to the safety of the medicinal product.
• Herbal substances/preparations are complex mixtures of constituents and adding to that, HMPs, i.e., multiple herbal substances/preparations of different origin in the same medicinal product, are frequent.
• Herbal substances/preparations are also found in other product categories, like food supplements, cosmetics or medical devices, with different quality requirements compared to medicinal products.

For more information please see the Reflection paper on particulars for safety signals for (traditional) herbal medicinal products published on the EMA website.