PV Bulletin

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Npra.gov.my

publicNational Pharmaceutical Regulatory Agency (NPRA), Malaysia · Malaysia · Updated Aug 25, 2026

List of Cosmetic Manufacturers in QUEST System in Malaysia

Urgency: High

Review and verify that any cosmetic products sourced or distributed comply with the manufacturers listed in the updated QUEST system.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicNPRA, Malaysia · Malaysia · Updated Aug 26, 2026

National Centre for Adverse Drug Reaction Monitoring Annual Report

Urgency: High

Healthcare organizations should review the NPRA annual report to ensure compliance with updated safety monitoring practices and adjust their reporting and signal management processes accordingly.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicNPRA (Malaysia) · Malaysia · Updated Aug 16, 2026

Plasma Products Lot Release: Notification of Non Compliance

Urgency: High

Entities affected by this notification must review their plasma product lot processes and ensure compliance with NPRA regulations. Affected stakeholders should adjust workflows to address non-compliance issues.

LabelingCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMalaysia · Updated Aug 16, 2026

Vaccine Lot Release: Notification of Non Compliance

Urgency: High

Implement an immediate review of affected vaccine lots and ensure all relevant stakeholders are informed of the compliance issues for Signal Management processes.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMalaysia · Updated Aug 16, 2026

Vaccine Lot Release: Notification of Non Compliance

Urgency: High

Organizations must increase scrutiny and evaluation of vaccine safety profiles for lots identified in the notification of non-compliance.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward

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