Pharmacovigilance Services in Indonesia

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Indonesia, and looking for pharmacovigilance services in Indonesia to ensure drug safety and regulatory compliance. From adverse drug reaction reporting to compliance with Badan POM pharmacovigilance (PV) regulations, the right PV partner impacts signal detection, risk management planning, safety reporting, and effective post-marketing surveillance.

Expert Pharmacovigilance Services for the Indonesia Market

The National Agency of Drug and Food Control (Badan POM or BPOM) is the National Centre of Pharmacovigilance services in Indonesia. As a government agency under Presidential Decree No. 80/2017, BPOM is responsible for protecting public health by overseeing the safety, efficacy, and quality of pharmaceuticals from pre-clinical stages through to post-marketing surveillance.

BPOM develops pharmacovigilance guidelines, national work plans, and policies, and handles the collection, evaluation, and benefit-risk assessment of adverse drug reactions (ADRs). ADR reporting in Indonesia is voluntary for healthcare professionals, via the “Yellow Form” and for consumers through an online report system. However, it is mandatory for marketing authorization holders (MAH) and manufacturers to report any adverse events using the CIOMS form. Additionally, pharmaceutical companies are required to establish dedicated pharmacovigilance units with a designated responsible person.

Beyond routine reporting, BPOM leads efforts to strengthen pharmacovigilance capacity in public health programs. For instance, Indonesia introduced active Drug Safety Monitoring and Management (aDSM) for anti-TB drugs in 2017. Under this system, BPOM reviews serious adverse event (SAE) reports and refers them to the National Pharmacovigilance Committee for causality assessment. WHO has also collaborated with BPOM to develop pharmacovigilance training, including curriculum for pharmacy and medical students, and support for pharmacovigilance coordination teams.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, including SUSARs
  • Case processing via E2B(R3)-compliant databases integrated with WHO Drug Dictionary and MedDRA
  • Quality checks and medical reviews
  • Submission in line with BPOM timelines
  • Maintenance of ICSR tracking sheets and reconciliation with customers
• + Risk Management Plan
  • Drafting, reviewing, and maintaining RMPs aligned with local pharmacovigilance requirements
  • Risk classification procedures and tailored risk management strategies
  • Implementation of Post-Authorization Safety Studies (PASS ), such as observational studies and follow-up tools
  • Risk communication via labeling documents like SmPC and patient information leaflets
• + Aggregate Reports
  • Preparation of PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), and ASRs (Annual Safety Reports)
• + Signal Management
  • Identification of new safety signals from ICSRs, literature, aggregate reports, and regulatory sources
  • Use of in-house tools for signal detection and tracking
  • Review of signals against ADR databases and PRAC-style recommendations
  • Label update analysis, risk minimization recommendations, and development of signal management trackers and annual reports
• + Qualified Person for Pharmacovigilance (QPPV)&(RPPV) Services
  • Review of Pharmacovigilance System Master File (PSMF), Safety Data Exchange Agreements (SDEAs), agreements with commercial partners, Pharmacovigilance Standard Operating Procedures (SOPs), etc.
  • Retainer services for QPPV Services and Deputy
  • Local Safety Responsible
  • Monthly reconciliation
  • Medical review of signal detection; Signal Surveillance Meetings (Quarterly)
  • Monthly communication report/provision of compliance metrics
  • Pharmacovigilance Quality Management System Oversight
• + Pharmacovigilance Audit & Compliance
  • Review audit and compliance to applicable pharmacovigilance guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (Standard Operating Procedures), and work instructions
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for pharmacovigilance inspections conducted by respective competent authorities
  • Conduct regular gap assessments of pharmacovigilance staff at site locations
  • Provide organizational training on safety audits and inspections