Tag archive

Npra.gov.my

publicNPRA (National Pharmaceutical Regulatory Agency) · Malaysia · Updated Aug 16, 2026

Reporting Side Effects to Medicines (ConSERF) or Vaccines (AEFI)

Implement operational changes to assess and process consumer reports on side effects, ensuring additional resources are allocated for evaluations.

Signal ManagementCountry ComplianceMedical Safety Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Medical Safety Lead

verifiedRegulatory action: reporting_requirement

Read impact briefarrow_forward

publicNPRA (Malaysia) · Malaysia · Updated Aug 16, 2026

Cancellation of Registered Complementary & Alternative Product

Urgency: High

Sellers and distributors are mandated to cease the sale and distribution of the affected products immediately and comply with penalties for non-compliance, which may include fines up to RM50,000 or imprisonment.

Signal ManagementRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead

verifiedRegulatory action: safety_signal

Read impact briefarrow_forward

publicNPRA · Malaysia · Updated Aug 16, 2026

Cancellation of Notified Cosmetic Products in Malaysia

Urgency: High

Sellers must stop the sale and distribution of the canceled products immediately and monitor for compliance with NPRA regulations to avoid legal penalties.

Signal ManagementRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead

verifiedRegulatory action: safety_signal

Read impact briefarrow_forward

Get updates for your PV role

Subscribe to impact-first pharmacovigilance updates. Select every role you want in your digest.

Digest roles: QPPV. Work email only