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BPOM Regulation No. 26 of 2025 concerning Risk Assessment of Ingredients Used in Natural Medicines, Health Supplements, Quasi-drugs, and Certain Cosmetic Products

Local Title
NOMOR 26 TAHUN 2025 TENTANG KAJIAN RISIKO PENGGUNAAN BAHAN BAKU DALAM OBAT BAHAN ALAM, SUPLEMEN KESEHATAN, OBAT KUASI, DAN KOSMETIK SEDIAAN TERTENTU
Country/Region
Indonesia
Competent Authority
Badan Pengawas Obat dan Makanan
Type
Regulation
Status
In force
Release Date
2025-10-03
Implementation Date
2025-10-03

On November 11, 2024, the Indonesian Food and Drug Supervisory Agency (BPOM) released a draft Regulation No. 26 of 2025 concerning Risk Assessment of Ingredients Used in Natural Medicines, Health Supplements, Quasi-drugs, and Certain Cosmetic Products for public consultation. On October 3, 2025, BPOM officially issued and enforced the finalized version.

The regulation requires that ingredients used in certain dosage forms of natural medicines, health supplements, quasi-drugs, and cosmetics comply with the standards and quality requirements applicable to pharmaceutical ingredients. These “specific dosage forms” refer to products that, based on BPOM’s risk assessment, may pose potential health hazards if pharmaceutical-grade ingredients are not used.

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