Pharmacovigilance Services in Malaysia

Are you a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Malaysia? Access to pharmacovigilance services in Malaysia is essential to ensure drug safety and compliance with local regulations. From adverse drug reaction (ADR) reporting to monitoring and managing safety signals, the right local pharmacovigilance partner Malaysia makes all the difference in delivering safe medicinal products to patients.

The National Pharmaceutical Regulatory Agency (NPRA), previously known as the Drug Control Authority (DCA), is the national authority responsible for pharmacovigilance. It oversees ADR monitoring, safety signal screening, and implements preventative actions to protect public health. The Malaysian Adverse Drug Reaction Advisory Committee (MADRAC), an advisory body under NPRA, manages and shapes pharmacovigilance programs in Malaysia.

Reporting of ADRs in Malaysia is voluntary for healthcare professionals (HCPs) but mandatory for product registration holders (PRHs). ADRs can be reported via post, fax, email or online using tailored forms:

• HCPs: prepaid blue form or online
• General public: Consumer Side Effect Reporting Form (ConSERF)
• Parents/guardians for minor vaccine adverse events: Borang Pemantauan Kesan Sampingan Ringan Selepas Pelalian
• PRHs: Suspect Adverse Reaction Report Form (CIOMS Form I)
• One persistent challenge in Malaysia is the underreporting of ADRs by both HCPs and the public.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs and SUSARs
  • Case processing via E2B(R3)-compliant databases integrated with WHO DD and MedDRA
  • Quality checks and medical reviews
  • Timely case submissions per agency requirements and timelines (including CIOMS reporting)
• + Risk Management Plan (RMP)
  • Draft, review, and maintain RMPs and REMS using formats accepted in Malaysia (EU RMP format preferred; US/Japan also accepted with local applicability justification)
  • Design safety-risk classification procedures and tailored PV risk management strategies
  • Assess potential risks and missing data; recommend mitigation methods
  • Implement supplementary measures, such as Post-Authorization Safety Studies (PASS) — observational studies, academic materials, follow-up questionnaires
  • Convey risks clearly through labelling documents like Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)
• + Aggregate Reports
  • Prepare and submit Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Annual Safety Reports (ASRs)
• + Signal Management
  • Identify new safety signals or risk changes using ICSR databases, literature, aggregate reports , and regulatory updates
  • Recommend risk minimization approaches and maintain a Signal Management Tracker and Annual Signal Reports
• + Responsible Person for Pharmacovigilance (RPPV) Services
  • Review PSMF, Safety Data Exchange Agreements (SDEAs), SOPs, and partner agreements
  • Offer retainer services for RPPV and deputy roles, including local contact obligations
  • Provide monthly reconciliation, compliance metrics, signal surveillance meeting support, and reporting
  • Local Literature Monitoring
• + PV Quality Management System Oversight & Audit
  • Conduct audits and ensure compliance with PV guidelines, SDEAs, SOPs, and work instructions
  • Deliver mock audits and gap assessments to ready your organization for NPRA inspections
  • Provide staff training on safety PV audits and inspections