Regulation of the Indonesian Food and Drug Authority Number 4 of 2026 Tightens Pharmacovigilance Reporting Deadlines and Expands the Responsibilities of Marketing Authorization Holders

Introduction

On 23 February 2026, the Badan Pengawas Obat dan Makanan (“BPOM”) issued Regulation of the Food and Drug Authority Number 4 of 2026 on the Implementation of Pharmacovigilance (“BPOM Regulation 4/2026”). This Regulation revokes and replaces Regulation of the Food and Drug Authority Number 15 of 2022 on the Implementation of Pharmacovigilance (“BPOM Regulation 15/2022”). This Regulation updates the legal framework for the implementation of pharmacovigilance in line with developments in science, technology, and current legal needs to ensure the safety of medicinal products circulating in the community.

BPOM Regulation 4/2026 implements Article 410 paragraph (1) of Government Regulation Number 28 of 2024 on Implementing Regulations of Law Number 17 of 2023 on Health. Through this regulation, BPOM strengthens the system for detecting, assessing, and preventing adverse drug reactions by clarifying the responsibilities of Marketing Authorization Holders and tightening the reporting timelines for adverse events.

 

Comparison

The following table sets out a comparison between BPOM Regulation 4/2026 and BPOM Regulation 15/2022:

 

Key Provisions

Obligations and Role of the Marketing Authorization Holder

Pursuant to Article 3, the Marketing Authorization Holder must implement Pharmacovigilance to ensure the safety of medicinal products in circulation, covering aspects of safety, efficacy (benefit–risk), and quality. The Marketing Authorization Holder may perform this obligation independently or appoint a Pharmacovigilance Service Provider (a third party) under a cooperation agreement, provided that such party has clearly designated personnel and is subject to inspection. The scope of Pharmacovigilance implementation covers various conditions of use, including:

1. Use in accordance with the approved marketing authorization (including Emergency Use Authorization);
2. Use outside the approved labeling (off-label use);
3. Abuse;
4. Misuse;
5. Overdose;
6. Medication error; and/or
7. Lack of efficacy.

Pharmacovigilance Infrastructure and Quality System

Article 4 requires the Marketing Authorization Holder to establish a system that includes:

1. Implementation of a quality system;
2. Establishment of a Pharmacovigilance unit within the organizational structure as a unit separate from commercial units;
3. Appointment of a person in charge and a deputy person in charge of the Pharmacovigilance unit;
4. Pharmacovigilance training;
5. Submission of a Pharmacovigilance system summary periodically every 2 (two) years and upon any significant change to the Pharmacovigilance system;
6. Implementation of a continuous safety profile monitoring process;
7. Preparation and implementation of an audit program for Pharmacovigilance implementation approved by top management;
8. Establishment, assessment, and implementation of a risk management system;
9. Signal management process;
10. Safety communication;
11. Reporting and documentation of Pharmacovigilance activities;
12. Implementation of regulatory follow-up actions determined by the Head of the Authority concerning decisions related to increased potential risks/safety signals of Medicinal Products; and
13. Preparation of cooperation agreements if Pharmacovigilance activities involve a Pharmacovigilance Service Provider and/or other relevant parties for the purpose of exchanging Medicinal Product safety data and information.

Risk Management Plan

Based on Article 6, the Marketing Authorization Holder must prepare a Risk Management Plan (RMP) document starting from the medicinal product development stage. This document constitutes a mandatory registration requirement for certain product categories, namely New Drugs, Biological Products (including biosimilars), and Medicinal Products that undergo changes that increase safety risks or where new safety issues are identified.

Reporting of AE and ADR

Article 9 regulates the classification and reporting deadlines for cases occurring in Indonesia:

1. Serious AE/ADR (resulting in death, life-threatening conditions, hospitalization, permanent disability, or congenital anomaly): Must be reported no later than 15 (fifteen) calendar days.
2. Non-Serious AE/ADR (unexpected): Must be reported no later than 90 (ninety) calendar days (accelerated from the previous 6-month requirement).

Reporting of AEFI for Vaccines

Specifically for vaccines, Article 10 stipulates the following reporting deadlines:

1. Serious AEFI (Death): Must be reported no later than 24 (twenty-four) hours.
2. Other Serious AEFI (Life-threatening, hospitalization, disability): Must be reported no later than 15 (fifteen) calendar days.
3. Non-Serious AEFI: Must be reported no later than 90 (ninety) calendar days.

Periodic Post-Marketing Reporting (Periodic Safety Update Report)

Article 11 requires periodic reporting for New Drugs, Biological Products, and Medicinal Products that undergo changes increasing safety risks or where new safety issues are identified. The reporting schedule is every 6 (six) months during the first 2 years after the marketing authorization is granted, and every 1 (one) year from the third to the fifth year.

Supervision and Administrative Sanctions

The Head of BPOM has the authority to conduct inspections of documents, facilities, and records owned by the Marketing Authorization Holder. If non-conformities are identified (classified as critical, major, or minor findings), BPOM may impose sanctions. Article 31 provides that violations of reporting and implementation obligations are subject to administrative sanctions in the form of:

1. Warning;
2. Written warning; and/or
3. Temporary suspension of Medicinal Product registration activities.

Transitional Provisions

Article 33 provides that the Marketing Authorization Holder must adjust all Pharmacovigilance activities to comply with BPOM Regulation 4/2026 no later than 26 February 2027.

 

Closing

BPOM Regulation 4/2026 updates the Pharmacovigilance legal framework by replacing BPOM Regulation 15/2022 and expands the responsibilities of Marketing Authorization Holders in ensuring the comprehensive safety, efficacy, and quality of medicinal products. This Regulation strengthens supervisory standards through the mandatory establishment of an independent unit, the implementation of a risk management system from the development stage, and accelerated adverse event reporting deadlines, particularly 90 days for non-serious cases and 24 hours for vaccine-related deaths. With the adjustment deadline set for 26 February 2027, full compliance is required, as violations of these provisions may result in administrative sanctions up to the temporary suspension of medicinal product registration activities.