PV Bulletin

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effective

publicSwissmedic · Switzerland · Updated Jun 15, 2026

SEND Format Requirement for New Authorisation Applications in Switzerland

Urgency: High

Ensure all relevant teams are prepared to transition to the mandatory SEND format for data submissions by the effective date of 15 June 2026.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Notice
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publicDanish Medicines Agency · Denmark · Updated Jun 29, 2026

Clinical Trials E-mail Notifications Activation in CTIS

Urgency: High

CTIS users are now required to actively monitor notifications daily to ensure timely awareness of safety-related tasks.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Regulatory Update
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publicCentral Drugs Standard Control Organisation (CDSCO) · India · Updated Jun 26, 2026

Submission of Post Approval Changes Applications of Registration Certificate and Import Licence of Human Vaccines and Anti-sera through SUGAM Portal

Urgency: High

MAHs must update their application submission procedures to utilize the SUGAM portal for all relevant post-approval changes from June 24, 2026.

Country ComplianceLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead, QPPV
verifiedRegulatory action: Circular
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publicHealth Canada · Canada · Updated Jun 25, 2026

Addition of Donanemab, Islatravir, and Pegzilarginase to Prescription Drug List

Urgency: High

MAHs must implement safety monitoring protocols and ensure compliance with reporting obligations associated with the newly classified prescription drugs.

Country ComplianceLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead, QPPV
verifiedRegulatory action: Notice
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