PV Bulletin

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reporting_requirement

publicEuropean Medicines Agency · European Union · Updated Jun 5, 2026

EMA: Updated Day 215 PI Annex Submission Checklist for Post-Opinion Linguistic Review

Monitoring

Update internal labeling workflows to align with the revised checklist; ensure submission documents meet updated formatting requirements for linguistic review.

LabelingRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead, QPPV
verifiedRegulatory action: Checklist
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publicNational Pharmaceutical Regulatory Agency (NPRA) · Malaysia · Updated Jun 10, 2026

NPRA Updates DRGD: Revised Processing Timelines for Variation Applications and Introduction of Reliance Mechanism

Monitoring

MAHs should review the updated DRGD to understand new processing timelines for variation submissions and assess how the reliance mechanism can be leveraged for faster safety updates. Adjust internal timelines and processes for post-marketing variation submissions accordingly.

Country ComplianceLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead, QPPV
verifiedRegulatory action: Guidance Update / Circular
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