Reflection paper on particulars for safety signals for (traditional) herbal medicinal products

Key changes

Guidance on handling complex botanical data and bridging gaps in spontaneous reporting for signal management.

PV impact

Stakeholders must adapt signal management workflows for herbal products to incorporate specific detection and assessment criteria.

Exact policy details

Start of public consultation

15 July 2026

Applies to: For the reflection paper on safety signals for traditional herbal medicinal products

Start of public consultation · p. 1 · High · Source

End of consultation deadline for comments

15 October 2026

Applies to: For the reflection paper on safety signals for traditional herbal medicinal products

End of consultation (deadline for comments) · p. 1 · High · Source

Safety signal generation

Includes spontaneous reports, clinical studies, scientific literature

Applies to: For assessing safety of traditional herbal medicinal products

A safety signal is information arising from one or multiple sources · p. 3 · High · Source

Quality requirements for herbal products

Herbal substances must be tested for microbiological quality, mycotoxins, residues of pesticides, heavy metals

Applies to: Related to safety of traditional herbal medicinal products

Generally, herbal substances must be tested for microbiological quality, mycotoxins, residues of pesticides and fumigation agents · p. 4 · High · Source

Duration of safe use prior to approval

More than 30 years

Applies to: For traditional herbal medicinal products in the EU

the requirements include safe use for more than 30 years before approval · p. 4 · High · Source

Workflow rule impacts

Extracted documents

• Reflection paper on particulars for safety signals for (traditional) herbal medicinal productspdfpdf_text · high · 5 pages