PV Bulletin

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publicSwissmedic (Swiss Agency for Therapeutic Products) · Switzerland · Updated Jun 22, 2026

Adoption of ICH E6(R3) Annex 2 for Good Clinical Practice

Urgency: High

MAHs and trial sponsors must align their safety monitoring and data collection workflows with the new GCP principles established in ICH E6(R3) Annex 2.

Inspection ReadinessCAPARegulatory Intelligence Lead
SOP Impact3 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, PV Quality Lead
verifiedRegulatory action: Notice
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publicSwissmedic · Switzerland · Updated Jun 19, 2026

Swissmedic Guidance on Injectable Products for Wrinkle Treatment

Urgency: High

Healthcare professionals must report all serious incidents involving injectable devices to Swissmedic as outlined in the new guidance.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Guidance
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publicTherapeutic Goods Administration (TGA) · Australia · Updated Jun 18, 2026

Update to listed medicine ingredients in June 2026

Urgency: High

Sponsors must align their products with the updated safety and formulation requirements for permissible ingredients as per the new determination.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Notice
Read impact briefarrow_forward

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