PV Bulletin

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publicHealth Sciences Authority (HSA) Singapore · Singapore · Updated Jun 30, 2026

Extension of e-labelling to P and GSL medicines

Urgency: High

Manufacturers must adjust labeling workflows to incorporate e-labelling mechanisms, such as QR codes, for P and GSL medicines by the stipulated date.

LabelingRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead, QPPV
verifiedRegulatory action: Regulatory Update / Notice
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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
Read impact briefarrow_forward

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