PV Bulletin

Tag archive

guidance

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
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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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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