Indonesia BPOM Drafts Broader Pharmacovigilance Rules for Cosmetics

On June 30, 2026, Indonesia's Food and Drug Supervisory Agency (BPOM) released a draft BPOM Regulation on the Implementation of Pharmacovigilance for Natural Medicines, Quasi-Drugs, Health Supplements and Cosmetics.¹ Public comments are accepted through bit.ly/Masukan-PV2026 until July 20, 2026.

The draft shifts from a cosmetics-specific "adverse reaction monitoring" framework to a broader pharmacovigilance system. For cosmetic companies, the most important changes are new system-building obligations, the introduction of safety signal reporting, as well as clearer documentation and inspection rules.

1. From Adverse Reaction Monitoring to a Pharmacovigilance System

Under the 2019 regulation, cosmetic notifiers were required to monitor, record, collect data, report, evaluate, and follow up on unwanted effects arising from cosmetic use. The draft keeps this core safety monitoring obligation but reframes it as part of a broader pharmacovigilance system. The new draft defines pharmacovigilance broadly as all activities for the detection, assessment, understanding, communication, control, and prevention of side effects or other issues related to the use of cosmetics.

Under the draft, every cosmetic notifier must implement pharmacovigilance to ensure the safety of products in circulation. For cosmetics, pharmacovigilance applies to the use of cosmetics and covers safety aspects and quality aspects that may affect cosmetic safety.

A key structural change is that companies may either implement pharmacovigilance themselves or appoint a designated pharmacovigilance implementer. If a pharmacovigilance implementer is appointed, it must:

• Be located in Indonesia;

• Have personnel, a reachable address, and a contact number; and

• Be available for BPOM pharmacovigilance inspection.

Where a third-party implementer or other parties are involved, companies must also prepare a cooperation agreement covering at least the agreement period, products covered, and the roles and responsibilities of each party in pharmacovigilance activities.

2. New Internal Organization and Personnel Expectations

The draft places stronger emphasis on internal organization. Cosmetic notifiers are expected to have a system that reflects their responsibilities and capacity. Under the system, the notifiers should have written procedures that cover the collection and receipt process, reporting of safety aspects, and the necessary follow-up actions to ensure the safety of distributed products. This follow-up can be voluntary or regulatory action determined by the BPOM.

For Cosmetic Manufacturers

Cosmetic manufacturers must have a unit responsible for cosmetic pharmacovigilance. This may be:

• A newly established unit; or

• An existing unit with added pharmacovigilance duties, such as a quality assurance unit.

The company must also appoint a pharmacovigilance responsible person with sufficient authority to ensure the quality system and implementation of cosmetic pharmacovigilance activities. The person's duties must be described in a job description.

For Importers and Contract Manufacturing Businesses

For importers and businesses conducting contract manufacturing, the technical responsible person may establish the cosmetic pharmacovigilance system. The draft also states that this person should receive training on pharmacovigilance implementation.

3. Reporting Scope Expanded: KTD, Side Effects and Safety Signals

The 2019 regulation focused on "side effects" after normal cosmetic use, divided into serious and non-serious effects. The draft expands the reporting framework by introducing KTD, meaning an undesirable medical event occurring during product use, but not necessarily caused by the product.

For cosmetics, the draft provides two categories of pharmacovigilance reporting: