Global Cosmetic Compliance
Intelligence & Solutions
BPOM Regulation No.34 of 2025 Concerning Amendments to Regulation No. 8 of 2024 Concerning Procedures for Approval of Clinical Trial Implementation
Local Title:
NOMOR 34 TAHUN 2025 TENTANG PERUBAHAN ATAS PERATURAN BADAN PENGAWAS OBAT DAN MAKANAN NOMOR 8 TAHUN 2024 TENTANG TATA LAKSANA PERSETUJUAN PELAKSANAAN UJI KLINIK
Country/Region:
Indonesia
Competent Authority:
Badan Pengawas Obat dan Makanan
Type:
Regulation
Status:
In force
Release Date:
2025-12-31
Implementation Date:
2025-12-31
Document
Language Source Title Access
ID
Official BPOM Regulation No.34 of 2025 Concerning Amendments to Regulation No. 8 of 2024 Concerning Procedures for Approval of Clinical Trial Implementation
BPOM Regulation No.34 of 2025 Concerning Amendments to Regulation No. 8 of 2024 Concerning Procedures for Approval of Clinical Trial Implementation
request
Summary

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.

History
2025-12-31
BPOM Regulation No.34 of 2025 Concerning Amendments to Regulation No. 8 of 2024 Concerning Procedures for Approval of Clinical Trial Implementation
In force
Release Date: 2025-12-31
Implementation Date : 2025-12-31
2024-11-04
2024-05-21
Invalid
Release Date: 2024-05-21
Implementation Date : 2024-05-21
User Guide