PV Bulletin

Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Drug safety and regulatory intelligence for QPPV, Signal, Labeling, PV Ops, and Device Vigilance — daily briefings with operational next steps.
Urgency: high

Latest intelligence

publicMHRA · UK · Updated Aug 25, 2026

Changes to Regulated Activity with Children Effective September 2026

Urgency: High

Organisations should review their DBS checking arrangements, especially prioritizing checks that include the Children's Barred List for those working with children, as part of their compliance with the new definition from September 2026.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
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publicMHRA · UK · Updated Aug 25, 2026

APHA Strengthens Bluetongue Disease Response

Urgency: High

Submit bluetongue samples to APHA with forms attached securely on the outside of the parcel to facilitate rapid booking into their digital sample handling system.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 25, 2026

Pain and Arthritis Products Containing Hidden Ingredients

Urgency: High

Monitor and reassess affected pain and arthritis products, ensuring compliance with safety reporting protocols for products listed with known hidden ingredients.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Signal Management Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 25, 2026

Qu Feng Huo Lou Dan May Be Harmful Due to Hidden Ingredient

Urgency: High

Consumers should consult healthcare professionals if using this product and report any adverse effects to FDA’s MedWatch Safety Information.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Signal Management Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 25, 2026

FDA Approves First Drug for Warm Autoimmune Hemolytic Anemia

Urgency: High

Healthcare providers and manufacturers must now comply with new reporting obligations for adverse reactions associated with the use of Imaavy and ensure adherence to increased compliance requirements for its administration.

LabelingSignal ManagementRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 25, 2026

Ongoing Accelerated Approvals for Infectious Disease Products

Urgency: High

Regulatory intelligence teams should review ongoing studies and compliance with postmarketing requirements for the drugs listed, specifically focusing on their deadlines for completion and the nature of the studies required.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 25, 2026

FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar

Urgency: High

Stakeholders should incorporate the device authorization into labeling and signal management protocols to ensure compliance and effective communication regarding its capabilities.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 25, 2026

Guidance on Use of Clove Oil as Anesthetic for Fish

Urgency: High

Regulatory intelligence teams must update workflows to exclude clove oil as an anesthetic for fish and ensure compliance with the guidance, including awareness of approved alternatives.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward