Tag archive

Consultation

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

TGA Consultation on Radiopharmaceutical Regulation in Australia

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

Read impact briefarrow_forward

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

Read impact briefarrow_forward

Get updates for your PV role

Subscribe to impact-first pharmacovigilance updates. Select every role you want in your digest.

Digest roles: QPPV. Work email only