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