Tag archive

consultation

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

Proposed Regulation for Complementary Health Products in Singapore

Urgency: 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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publicEuropean Medicines Agency · European Union · Updated Jun 29, 2026

Regulatory Changes in Pharmacovigilance Data Management Following EMA's ISG Meeting

Urgency: High

MAHs must align their workflows to accommodate the updated requirements for signal management and ICSR submissions as per the discussions in the ISG meeting.

Signal ManagementICSRRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Consultation / Forum

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publicTherapeutic Goods Administration (TGA) · Australia · Updated Jun 5, 2026

TGA Consultation on Radiopharmaceutical Regulation in Australia

Monitoring

Review the consultation document and consider submitting feedback by 2026-07-31. Monitor for final regulatory changes affecting radiopharmaceutical safety monitoring and compliance.

Country ComplianceRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Consultation

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publicEuropean Medicines Agency · European Union · Updated Jun 24, 2026

ICH E22 Guideline on Patient Preference Studies Comments Overview

Monitoring

Stakeholders, including those involved in labeling and signal management, should consider the published comments to align future processes with the regulatory expectations detailed in the draft ICH E22 guideline.

LabelingSignal ManagementRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead, Labeling Lead

verifiedRegulatory action: Consultation

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