PV Bulletin

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

This reflection paper provides guidance on signal management for herbal medicinal products, emphasizing the need for adapted workflows and specific detection criteria.

Primary source: European Medicines Agency (EMA)

PV Impact Brief

Urgency: HighConfidence: high

What changed

Stakeholders must adapt signal management workflows for herbal products to meet specific detection and assessment criteria as outlined in the reflection paper.

Why it matters

Improving safety signal detection and assessment for herbal medicinal products is crucial given their unique complexities, ultimately enhancing patient safety.

Action needed

Implement increased documentation and reporting processes for traditional herbal medicinal products. Ensure staff receive training on the complexities involved in signal management for these products.

Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review before 2026-10-31.

Policy change details

Document type
Draft Guidance
Policy status
Consultation
Publication date
2026-07-15
Consultation deadline
2026-10-31
Policy change
Explores specific considerations for signal management of herbal medicines, including traditional use products. It aims to optimize signal detection and assessment for these products.

Key changes

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

Affected workflows

Signal Management

PV impact

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

View regulator source

Source document details

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

Signal ManagementPharmacovigilance Department

May require additional training for staff regarding herbal product safety signals.

Increased emphasis on documentation and reporting for traditional herbal medicinal products due to complexity of constituents.

the composition of herbal substances/preparations as active substance of (traditional) herbal medicinal products presents a challenge. · p. 5 · High · Source
Country ComplianceRegulatory Affairs

Possible changes in local legislation and compliance practices for herbal products.

Need to align national regulations with EU guidelines on herbal medicinal products.

In conjunction with Directive 2001/83/EC, Regulation (EC) No 726/2004 and Commission Implementing Regulation (EU) No 520/2012. · p. 5 · High · Source

Evidence and confidence

Confidence: highSource updated: Jul 15, 2026

Full briefing

Practical implication

Implement increased documentation and reporting processes for traditional herbal medicinal products. Ensure staff receive training on the complexities involved in signal management for these products.

The European Medicines Agency has released a reflection paper focusing on safety signal management for traditional herbal medicinal products. Stakeholders are required to adapt their signal management workflows to address the unique challenges posed by the complexity of constituents in these products. There is a public consultation starting on July 15, 2026, with a deadline for comments set for October 15, 2026.

What changed: Stakeholders must adapt signal management workflows for herbal products to meet specific detection and assessment criteria as outlined in the reflection paper.

Why it matters: Improving safety signal detection and assessment for herbal medicinal products is crucial given their unique complexities, ultimately enhancing patient safety.

Practical implication: Implement increased documentation and reporting processes for traditional herbal medicinal products. Ensure staff receive training on the complexities involved in signal management for these products.

View original source

Published from the Firecrawl policy change extraction pipeline.

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