Quote from VigiServe Admin on November 27, 2020, 2:36 PM

Pharmacovigilance Requirements in Indonesia (as of 2026)

Indonesia's Pharmacovigilance system is managed by the National Agency of Drug and Food Control (BPOM) through the National Pharmacovigilance Center. Regulated by the recently enacted BPOM Regulation No. 4 of 2026, the framework aligns with ICH and WHO standards, mandating strict local compliance, electronic reporting, and active risk management.

Legal Framework and Governance

• Primary Regulation: BPOM Regulation No. 4 of 2026 on Pharmacovigilance Implementation.

• Oversight: BPOM conducts routine, risk-based Pharmacovigilance Inspections. Non-compliance results in administrative sanctions ranging from warnings to marketing authorization suspension.

Organization and Personnel

• Local Qualified Person for Pharmacovigilance: Mandatory. Marketing Authorization Holders must appoint a primary person responsible and a deputy. They must reside in Indonesia, be accessible 24/7, and serve as the main contact for BPOM.

• Pharmacovigilance System Master File: Marketing Authorization Holders must submit a Summary of Pharmacovigilance System (Ringkasan Sistem Farmakovigilans) to BPOM every two years or within one month of any significant system changes. This document acts as the local equivalent of the master file.

Post-Marketing Safety Reporting

Marketing Authorization Holders must report adverse events electronically:

• Serious Adverse Events: Within 15 calendar days of awareness.

• Fatal Adverse Events Following Immunization (Vaccines): Within 24 hours.

• Non-Serious Unexpected Adverse Events: Within 90 calendar days.

• Emerging Safety Issues: Within 3 working days of signal validation.

• Nil Reporting: If no events occur within a year, a "Nil" report must be submitted by January 10 of the following year.

Periodic Reporting

• Periodic Benefit-Risk Evaluation Reports / Periodic Safety Update Reports: Mandatory for new drugs, biologics, biosimilars, or products with identified safety concerns.

• Frequency: Every 6 months for the first two years post-approval, then annually for years three through five.

Risk Management Plans

• Mandate: Mandatory for new drugs, biologics, and products with significant safety profile changes.

• Implementation: Must be submitted during initial registration. Requires routine safety monitoring and, if necessary, additional risk minimization measures (e.g., restricted distribution, post-authorization safety studies).

Clinical Trials

Regulated under BPOM Good Clinical Practice guidelines:

• Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs).

  • Fatal or Life-Threatening: Within 7 calendar days.

  • Other Serious Unexpected: Within 15 calendar days.

• Phase IV/Observational Studies: Must be notified to BPOM prior to initiation, with final reports submitted within six months of data collection completion.

Summary of Requirements

Component	Requirement in Indonesia
Regulatory Authority	BPOM (Badan Pengawas Obat dan Makanan)
Framework	BPOM Reg No. 4 of 2026
Local Qualified Person	Yes (Resident in Indonesia)
System Master File	Yes (Summary of Pharmacovigilance System)
Safety Reporting	15 days (Serious) / 90 days (Non-Serious)
Clinical Reporting	SUSARs (7/15 days)
Submission Language	Indonesian / English