PV Bulletin

Search Pharmacovigilance & Regulatory Intelligence

Search published pharmacovigilance and regulatory intelligence briefings by regulator, product, workflow, QPPV topic, or safety signal.

Found 10 result(s) for "HSA".

Showing 1-10 of 10 published article match(es)

publicHealth Sciences Authority (HSA) · Singapore · Updated Jul 1, 2026

Proposed Regulation for Complementary Health Products in Singapore

Immediate · High

Suppliers must implement new protocols for safety reporting and record-keeping as per the proposed framework.

Country ComplianceSignal ManagementRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead, QPPV
verifiedRegulatory action: Consultation
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publicHealth Sciences Authority (HSA) Singapore · Singapore · Updated Jun 30, 2026

Extension of e-labelling to P and GSL medicines

Immediate · High

Manufacturers must adjust labeling workflows to incorporate e-labelling mechanisms, such as QR codes, for P and GSL medicines by the stipulated date.

LabelingRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead, QPPV
verifiedRegulatory action: Regulatory Update / Notice
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publicSwissmedic · Switzerland · Updated Jul 1, 2026

Change to Patient Information and Information for Healthcare Professionals Templates

Immediate · High

MAHs must ensure new medicinal product information texts use updated templates by 1 July 2026 and revise existing texts at the earliest opportunity if they include instructions for use.

LabelingRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead, QPPV
verifiedRegulatory action: Notice
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publicHSA · Singapore · Updated Jun 4, 2026

Urgent Field Action Notification of Advanced Bionics HiRes Ultra / Ultra 3D

Immediate · High

Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Urgent Field Action
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publicHSA · Singapore · Updated Jun 4, 2026

HeartWare Ventricular Assist System Batteries - HSA Field Safety Notice

Immediate · High

Identify and quarantine affected HeartWare batteries; follow manufacturer's instructions for battery management and replacement; ensure patients and healthcare providers are informed.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Field Safety Notice
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publicUK Health Security Agency · UK · Updated Sep 7, 2026

Low Flu Vaccination Rates Among Primary School Children

Immediate · High

Parents are reminded to complete and return flu vaccination consent forms promptly as vaccination sessions in schools are set to start this week, aiming for completion by late November.

Signal ManagementPV Quality Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: PV Quality Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
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publicUK Health Security Agency · UK · Updated Sep 3, 2026

Invasive mosquito species detected in east London

Immediate · High

UKHSA has implemented control measures to destroy larvae and is monitoring the area closely for further mosquito activity.

Signal ManagementLiterature SurveillanceMedical Safety Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Medical Safety Lead, Signal Management Lead
verifiedRegulatory action: Regulators
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publicUK Health Security Agency · UK · Updated Aug 27, 2026

UK Salmonella Outbreak Linked to Imported Eggs

Immediate · High

Implement enhanced surveillance and tracking of Salmonella cases linked to imported eggs, potentially increasing ICSR submissions related to these infections.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
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publicUK Health Security Agency · UK · Updated Aug 27, 2026

Vaccination Guidance to Improve Childhood Immunization Rates

Immediate · High

Parents are encouraged to ensure their children receive timely vaccinations according to the NHS schedule to increase overall immunization rates and adherence to WHO guidelines.

Country ComplianceMedical Safety Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Medical Safety Lead
verifiedRegulatory action: Regulators
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publicMHRA · UK · Updated Sep 3, 2026

AI Sleep Data Could Provide One-Week Early Warning of Flu and COVID-19

Monitor · Medium

Health agencies should integrate and evaluate passive digital monitoring data, such as cough signals from sleep apps, alongside traditional surveillance systems to enhance early warning capabilities.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceMedium
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
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