A new appendix for cosmetic clinical trials
BPOM Regulation No. 34 of 2025 adds Appendix IIIa to the existing clinical trial approval regulation. The appendix sets out guidelines for cosmetic clinical trials carried out in Indonesia.
According to the regulation, cosmetic clinical trials must receive ethics approval before the study starts from an ethics committee.
The appendix covers study design, implementation, participant protection, and technical procedures used during cosmetic clinical trials.
More structured guidance
BPOM explained that cosmetic innovation and scientific development have increased research activity in the cosmetics sector. Before this regulation, cosmetic clinical trials did not yet have comprehensive technical guidance. That situation could create different interpretations among companies, researchers, and supervisory authorities.
The new regulation sets out principles, study design requirements, implementation procedures, and ethical aspects for cosmetic clinical trials in a more structured way. BPOM stated that the regulation aligns with Law No. 17 of 2023 on Health and Government Regulation No. 28 of 2024.
Risk categories and ethics approval
Appendix IIIa divides cosmetic products into risk categories.
High risk products require approval from an Independent Ethical Committee. These include products used on sensitive areas, products containing nanomaterials or new ingredients without documented safety history, products involving invasive procedures, or studies involving vulnerable groups.
Low risk products that do not meet those criteria may receive approval from an Internal Ethical Committee. Examples listed include cleansers, moisturizers, fragrances, and decorative cosmetics.
The appendix also sets requirements for internal ethics committees, including member composition, participation of lay members not affiliated with the company, and independence from the research team.
Restrictions on study participants
Appendix IIIa Letter B Number 2 states that cosmetic industry employees or sponsor employees cannot be used as clinical trial subjects for products from their own company.
General sponsor obligations
The regulation includes general obligations for sponsors across all commodities covered by BPOM Regulation No. 34 of 2025.
Sponsors must validate electronic systems used during clinical trials. Serious adverse events must be reported within the required timeframe, including reports submitted within 24 hours after the event becomes known.
Sponsors are responsible for the quality and reliability of clinical trial data, including work carried out by third parties such as Contract Research Organizations, or CROs.
Cosmetic claims and scientific evidence
BPOM stated that the regulation was introduced partly because of increasing demand for scientific proof supporting cosmetic product claims.
The agency said the regulation is intended to support cosmetic clinical trials in Indonesia so they are more credible, ethical, and able to support claims for products that are safe and of good quality for the public.
