CPOB Standards Set to Tighten for Plasma-Derived Drug Products with New Traceability, Safety and Documentation Requirements: Input Open until 28 August 2026

The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan – “BPOM”) is currently completing a work on a new Draft Regulation on the Second Amendment (“Draft Regulation”) to Regulation of the BPOM No. 7 of 2024 on Standards for Good Drug Manufacturing Practices (Cara Pembuatan Obat yang Baik – “CPOB”), as amended previously by Regulation of the BPOM No. 7 of 2025 (collectively referred to as “Regulation 7/2024”). The Draft Regulation is currently undergoing a process of internal deliberation at the BPOM and may thus be subject to further changes.[1]