On June 30, 2026, the Indonesian Food and Drug Authority (BPOM) opened for public comment on the Draft Regulation on the Implementation of Post-Market Safety Surveillance for Natural Medicines, Quasi-drugs, Health Supplements, and Cosmetics, with feedback due by July 20, 2026.
The draft brings the above four product categories under a unified pharmacovigilance framework (post-market safety surveillance) and consolidates and replaces the current cosmetic-specific regulation BPOM No. 26 of 2019, setting out clear requirements on the reporting entities, seriousness criteria, and reporting timelines for cosmetic adverse events. CIRS Group has compiled and summarized the cosmetics-relevant contents of the draft for your reference.
Background
Indonesia operates a post-market adverse-reaction monitoring system for cosmetics, currently governed by BPOM Regulation No. 26 of 2019 on the Cosmetic Side-Effect Monitoring Mechanism. The current draft, based on Article 410(1) of Government Regulation No. 28 of 2024 (PP 28/2024) — the implementing regulation of the 2023 Health Law (Law No. 17 of 2023) — brings natural medicines, quasi-drugs, health supplements, and cosmetics under a unified pharmacovigilance framework and sets out category-specific requirements. The existing BPOM Regulation No. 4 of 2021 (side-effect monitoring for natural medicines and health supplements) and BPOM Regulation No. 26 of 2019 (cosmetics) will be repealed and integrated.
Main Cosmetics-Relevant Contents
1. Scope and Key Definitions
- Cosmetic: a substance or preparation intended for use on the external parts of the human body (epidermis, hair, nails, lips, external genital organs, as well as teeth and oral mucosa) for cleaning, perfuming, changing appearance, correcting body odor, protecting, or keeping in good condition;
- Adverse Event (AE, abbreviated KTD in Indonesian regulation): any event occurring during the distribution or use of a product that is or may be harmful to consumer health (the draft applies the KTD concept uniformly to cosmetics);
- Pharmacovigilance responsible entity: the Marketing Authorization Holder (MAH— i.e., the notification/marketing-authorization holder, and for imported products its domestic representative) must establish and operate a pharmacovigilance system and report to the BPOM National Pharmacovigilance/MESO Center.
2. Reporting Entities
- Marketing Authorization Holder (MAH): must implement pharmacovigilance and report in accordance with the draft;
- Healthcare professionals at healthcare facilities: must report KTDs/adverse reactions in accordance with relevant provisions;
- Consumers: may act as KTD reporters (meaning non-healthcare professionals, such as the user, relatives, etc.).
3. Serious Adverse Event (Serious AE / KTD Serius) Criteria for Cosmetics (Draft Article 10)
A serious cosmetic KTD covers any medical event resulting in any of the following: death, life-threatening, hospitalization or prolongation of hospitalization, permanent disability, etc.
4. Cosmetic Adverse-Event Reporting Timelines (Draft Article 10)
| Scenario | Reporting Timeline (from the date first known) |
| Serious KTD (death / life-threatening) | Report within 7 days |
| Serious KTD (hospitalization / disability, etc.) | Report within 15 days |
| Non-serious KTD (Non-serious AE) | Cumulative report every 6 months (January and July), including “zero reports” |
| Hair-dye cosmetics (products listed in Annex II) | Non-serious KTD reported every 3 months (January, April, July, October) |
5. Quality-System Requirements
The MAH must establish a pharmacovigilance quality-management system, carry out corrective and preventive actions (CAPA) and internal audits, and designate a person in charge to coordinate pharmacovigilance activities.
CIRS Reminder
Once in force, the draft will further unify and tighten Indonesia's existing cosmetic adverse-reaction monitoring framework, with a direct impact on MAHs of cosmetics sold in Indonesia. CIRS Group offers the following reminders:
- Clarify the responsible entity: the cosmetic MAH (for imported products, its domestic representative) is the primary pharmacovigilance responsible party and must establish internal controls for collecting, recording, and reporting adverse-reaction information;
- Mind the short timelines: the 7-day / 15-day reporting deadlines for serious KTDs are tight — set up internal reporting channels and emergency contacts in advance to ensure timely compliance;
- Fulfill the “zero report” obligation: non-serious KTDs must be submitted cumulatively every 6 months (for general cosmetics), including a “zero report” where no adverse event has occurred;
- Track the progress of the draft: it remains a draft at this stage; the final scope, timelines, and format requirements are subject to the official BPOM regulation.
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