BPOM Regulation No.34 of 2025 Concerning Amendments to Regulation No. 8 of 2024 Concerning Procedures for Approval of Clinical Trial Implementation

On December 31, 2025, Indonesia released and implemented an amendment to BPOM Regulation No. 8 of 2024 on the Procedures for Approving Clinical Trials. The amendment clarifies that cosmetic clinical trials conducted in Indonesia must obtain an ethical approval from an ethics committee or an internal ethics committee before commencement. In addition, cosmetic companies may choose to apply to BPOM for clinical trial implementation approval.

The amendment also introduces Appendix IIIa, which sets out specific guidelines for conducting cosmetic clinical trials.