Cosmetic Compliance
Intelligence & Solutions
BPOM Regulation No. 8 of 2024 Concerning Procedure for Approval of Clinical Trials
Local Title:
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:
2024-05-21
Implementation Date:
2024-05-21
Document
Language Source Title Access
ID
Official BPOM Regulation No. 8 of 2024 Concerning Procedure for Approval of Clinical Trials
On-demand Translation Service
BPOM Regulation No. 8 of 2024 Concerning Procedure for Approval of Clinical Trials
request
Summary

On May 21, 2024, Indonesian Food and Drug Supervisory Agency (BPOM) issued and implemented Regulation No. 8 of 2024, replacing the previous BPOM Regulation No. 21 of 2015 on clinical trial approval procedures. The updated regulation clarifies the requirements for conducting clinical trials on a range of products, including cosmetics, processed foods, health supplements, natural medicines, and quasi-drugs. Sponsors or contract research organizations that conducted trials before May 21, 2024 must comply with the updated regulation within six months.

Clinical trials are mandatory for certain drugs (including cosmetics) and foods to ensure product safety and efficacy. Regulation No. 8 of 2024 sets forth requirements for test products used in clinical trials, serious adverse event reports, and clinical trial implementation reports, supervision requirements for the conduct of clinical trials, as well as administrative penalties for non-compliance. Additionally, the annex to the regulation includes guidance on good clinical trial practices applicable to cosmetics. This provides a standardized framework to help testing practitioners conduct cosmetics trials in accordance with good practices.

User Guide