Indonesia BPOM Strengthens Cosmetic Clinical Trial Requirements Under Regulation No. 34 of 2025

On December 31, 2025, Indonesia’s National Agency of Drug and Food Control (BPOM) issued “BPOM Regulation No. 34 of 2025,” amending “BPOM Regulation No. 8 of 2024 on the Procedures for Clinical Trial Approval.” The amendment strengthens Indonesia’s clinical trial approval framework and introduces more detailed regulatory provisions for cosmetic clinical trials, an area that previously lacked comprehensive guidance.

For international cosmetic manufacturers and product sponsors conducting clinical trials in Indonesia, the regulation introduces more explicit expectations for study design, ethical approval, and documentation supporting cosmetic safety and benefit claims.

BPOM Introduces Structured Requirements for Cosmetic Clinical Trials

A central objective of the amendment is to create a clearer regulatory framework for clinical testing of cosmetic products in Indonesia. BPOM cited several factors driving the update, including:

• Increasing innovation in cosmetic formulations
• Growing complexity of product benefit claims
• Absence of detailed regulatory guidance for cosmetic clinical trials under the previous framework

By introducing clearer requirements, the agency aims to ensure that cosmetic claims marketed in Indonesia are supported by reliable scientific evidence while strengthening consumer protection.

Mandatory Reference to Cosmetic Clinical Trial Guidelines

The regulation introduces a requirement that cosmetic clinical trials must follow the Cosmetic Clinical Trial Guidelines set out in Annex IIIa of the regulation. These guidelines form an integral part of the regulatory framework, defining methodological standards and documentation expectations for cosmetic clinical studies conducted in Indonesia and serving as the primary reference for clinical trials that support cosmetic safety and performance claims.

Ethical Approval Requirements for Cosmetic Clinical Trials

The regulation also establishes clearer ethical oversight requirements for cosmetic clinical studies. Before initiating a cosmetic clinical study, sponsors must obtain ethical approval from one of the following bodies:

• An independent Ethics Committee, or
• An Internal Ethics Committee that meets BPOM regulatory standards

Ethical approval must be granted before the clinical trial begins and must comply with the standards defined in Annex IIIa.

These requirements reinforce BPOM’s focus on protecting research participants and ensuring that cosmetic clinical testing is conducted according to recognized ethical standards

Scientific Principles Governing Cosmetic Clinical Studies

The Cosmetic Clinical Trial Guidelines also establish core scientific principles that must guide cosmetic clinical trial design.

BPOM emphasizes that studies supporting cosmetic safety and efficacy claims must rely on scientifically valid methodologies and generate reliable, reproducible data.

Key principles outlined in the guidelines include:

• Use of validated and published research methodologies
• Prioritization of participant safety throughout the study
• Trial designs that minimize bias and variability
• Generation of reliable data to substantiate safety and benefit claims

In addition, cosmetic clinical trials are categorized based on product risk level. Studies involving higher-risk ingredients or more complex performance claims may be subject to stricter ethical and regulatory oversight.

Clarification of Clinical Trial Approval (PPUK) Requirements

The amendment also clarifies the requirements surrounding Clinical Trial Approval, known locally as PPUK. BPOM confirms that clinical trials conducted in Indonesia for the following categories require prior approval from the agency:

• Drugs
• Traditional medicines
• Quasi-drugs
• Health supplements

Clinical Trial Approval must be obtained before a study begins and can only be issued after the relevant ethical review has been completed.

The regulation also clarifies a limited exemption. Certain post-marketing clinical trials conducted for educational purposes may be exempt from the PPUK requirement, depending on the design and objectives of the study.

Compliance Considerations for Cosmetic Manufacturers

For international cosmetic companies operating in Indonesia, the regulation provides a clearer pathway for substantiating product claims through clinical evidence. Manufacturers planning to introduce innovative claims, incorporate new or higher-risk ingredients, or rely on clinical trial data to support product benefits must ensure that study protocols comply with the requirements outlined in “BPOM Regulation No. 34 of 2025” and its annexes.

In practice, however, foreign sponsors may face delays due to misaligned clinical trial design, incomplete documentation, or ethics committee requirements that are not fully understood during early planning.

Early regulatory assessment can help align study design, ethical approvals, and submission documentation with BPOM expectations. Cisema supports international manufacturers by translating Indonesia’s evolving cosmetic and clinical trial regulations into clear, actionable compliance strategies. For support with Indonesia cosmetic regulatory requirements and clinical trial planning, contact Cisema today.

References

Further details can be reviewed in the official document, “BPOM Regulation No. 34 of 2025 on Amendments to the Procedures for Clinical Trial Approval,” available from the Indonesian National Agency of Drug and Food Control.