Introduction
BPOM Regulation No. 34 of 2025 is an amendment to BPOM Regulation No. 8 of 2024 on the Procedures for Approval of Clinical Trial Implementation. This regulation was promulgated on 31 December 2025 and came into force on the same date.
The amendment was introduced to address the absence of a specific regulatory framework for cosmetic clinical trials in Indonesia, particularly in light of the rapid development of cosmetic innovation and increasingly complex product claims that require scientific substantiation prior to market placement.
As highlighted by Mr. Mohamad Kashuri, S.Si., Apt., M.Farm, Deputy for Supervision of Traditional Medicines, Health Supplements, and Cosmetics, during the BPOM socialization session on 26 January 2026, clinical trials for cosmetics are not mandatory requirements. However, for businesses conducting innovation and intending to include specific claims on product labels, such claims must be supported by scientific evidence, one of which may include clinical trials.
To ensure transparency, validity, and reliability of clinical trial results, it is necessary to establish clear regulatory principles and standards governing cosmetic clinical trials. BPOM Regulation No. 34 of 2025 responds to this need by introducing a dedicated framework aligned with science-based and evidence-based evaluation approaches, consistent with international practices.
Key Regulatory Changes
BPOM Regulation No. 34 of 2025 introduces limited but significant amendments to BPOM Regulation No. 8 of 2024, focusing on specific product categories, including cosmetics:
Article 5
A new paragraph (3a) is introduced, stipulating that cosmetic clinical trials must comply with the Cosmetic Clinical Trial Guidelines set out in Appendix IIIa, in addition to the general Good Clinical Practice (GCP/CUKB) guidelines in Appendix I.
Article 6
Editorial clarification confirms that Approval for Clinical Trial Implementation (PPUK) approval from BPOM is mandatory for clinical trials conducted in Indonesia for: Medicinal products, Traditional medicines, Quasi-drugs, and Health supplements. Clinical trials conducted for post-marketing educational research purposes are exempt from PPUK requirements. PPUK approval must be obtained after ethics committee approval and prior to trial initiation.
Article 7
Approval for Clinical Trial Implementation (PPUK) applications may also be submitted for cosmetic and/or processed food clinical trials conducted in Indonesia, provided that prior approval from an Ethics Committee has been obtained.
These changes are primarily editorial and additive in nature and do not alter the fundamental ethical principles of clinical trials, including respect for persons, beneficence, and justice.
Introduction of Appendix IIIa: Cosmetic Clinical Trial Guidelines
Appendix IIIa is introduced as a dedicated guideline for cosmetic clinical trials, which was previously not specifically regulated under BPOM Regulation No. 8 of 2024.
In principle, the scientific substantiation of cosmetic safety and benefits must be conducted in a stepwise manner, beginning with the evaluation of ingredient safety based on scientific references. Where available reference data are insufficient, clinical trials become necessary. For new cosmetic ingredients, adequate non-clinical data must be available prior to conducting trials in humans.
The guideline further emphasizes that cosmetic clinical trials must be scientifically sound and designed to minimize bias, using valid and published methodologies. Acceptable study designs may include randomized controlled studies, intra-individual comparisons, double-blind, single-blind, or open-label studies, depending on study objectives and data requirements, while always prioritizing subject safety.
Appendix IIIa introduces a risk-based classification of cosmetic clinical trials, distinguishing between high-risk and low-risk products. High-risk cosmetic clinical trials—such as products applied to sensitive areas, products containing certain ingredients (e.g. nanomaterials or specific skin-lightening agents), SPF testing, anti-aging products, and studies involving long-term exposure—must obtain approval from an Ethics Committee. For low-risk cosmetic products, ethical approval may be obtained through an Internal Ethics Committee, provided regulatory requirements are met.
BPOM Regulation No. 34 of 2025's Implications for the Cosmetic Businesses
Companies must define product claims at an early stage and design appropriate clinical trials to support those claims, such as “dermatologically tested”, “clinically tested”, or time-based performance claims (e.g. 72-hour moisturization).
Businesses must ensure readiness of clinical trial documentation, ethics approval, and selection of an appropriate ethics committee based on product risk.
Inappropriate study design or unsupported claims may pose regulatory compliance risks and negatively impact product marketing and credibility.
Clinical trial guidance under PerBPOM No. 34/2025 applies specifically to cosmetic clinical trials conducted in Indonesia. For cosmetic products that have already undergone clinical trials in their country of origin, the clinical data are not automatically subject to re-approval under this guidance, but may be evaluated during post-market surveillance, particularly when used to support product claims in Indonesia. At the same time, this guidance can serve as a practical reference for products under development that are intended to enter the Indonesian market, allowing companies to align their clinical study design, ethical considerations, and supporting documentation with local regulatory expectations to ensure compliance and reduce regulatory risk.
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