Tag archive

policy-change

publicMedicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) · United Kingdom · Updated Jun 15, 2026

Unique Liaison Programme between MHRA and FDA

Monitoring

MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

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

verifiedRegulatory action: Notice

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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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publicCanada's Drug Agency (CDA-AMC) · Canada · Updated Jun 5, 2026

CDA-AMC Post-Market Drug Evaluation (PMDE) Program Procedural Update

Monitoring

Review updated PMDE Program procedures on CDA-AMC website and assess impact on current post-market surveillance activities in Canada.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

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

verifiedRegulatory action: SOP

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