Amendments to BPOM Regulation No. 8 of 2024 Concerning Procedures for Approval of Clinical Trials (Draft)

Local Title

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

Invalid

Release Date

2024-11-04

Implementation Date

On November 4, 2024, the Indonesian Food and Drug Supervisory Agency (BPOM) issued draft Amendments to Regulation No. 8 of 2024 Concerning Procedures for Approval of Clinical Trials.

The amendments introduce a new Annex IIIa, which requires cosmetic clinical trials to adhere to the guidelines outlined in this annex.

The guidelines cover the following aspects:

Introduction
Safety and efficacy proof scheme
Implementation of cosmetic clinical trials
Researchers/investigators brochure
Instructions for creating information for prospective subjects
Closure