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Indonesia's medicines regulator. It licenses every medicine sold in the country, and since 2025 can approve a medicine in 90 working days by relying on the assessment of a reference regulator such as the European or United States agency.
BPOM grants the marketing authorisation (nomor izin edar) a medicine needs before it can be sold in Indonesia, under Peraturan Kepala BPOM 24 of 2017 on drug registration, amended for the fifth time by Peraturan BPOM 23 of 2025. In a press release of 31 December 2025 BPOM said the amendment introduced a reliance mechanism that shortens the evaluation of a medicine from 120 to 90 working days by drawing on the assessment of an established reference regulator. In April 2026 it listed the reference regulators as those of Europe, the United States, Australia, Canada, the United Kingdom, Japan and Switzerland, gave 50 working days for new medicines developed by companies investing in Indonesia and 100 working days for life-saving and orphan medicines, and said the share of accelerated authorisations had risen from 70.6 per cent in 2024 to 87.5 per cent in 2026.
BPOM reported 12,111 medicine authorisations from 2023 to the end of 2025, 86.26 per cent of them for domestically made products. The national cancer plan notes that many essential and innovative cancer medicines are not registered in Indonesia and are obtained through a special access scheme.
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