BPOM Prepares Regulation on the Export of Natural Medicines and Cosmetics

The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) is preparing a Draft Regulation on procedures for the issuance of Export Certificates (Surat Keterangan Ekspor - “SKE”) for natural medicines, quasi-drugs, health supplements, and cosmetics (“RPerBPOM”).

“This export certificate is one of the pre-market evaluation documents that ensures that national medicines, health supplements, and cosmetic products manufactured by Indonesian industries are guaranteed in terms of safety, quality, and efficacy,” said Muhammad Kashuri, Deputy for Supervision of Natural Medicines, Health Supplements, and Cosmetics.

This new regulation follows the enforcementof Regulation of the Government No. 28 of 2025 on the Organization of Risk-Based Business Licensing (PP 28/2025). The regulation stipulates that SKE is no longer included within the risk-based business licensing framework, but is instead regulated sectorally by BPOM through the National Single Window system (INSW).

The draft regulation emphasizes flexibility in requirements, tailored to the needs of the destination export country. SKE-related documents such as Certificate of Pharmaceutical Product (“CPP”) and Certificate of Free Sale (“CFS”) are planned to have a maximum validity period of two years. Meanwhile, Good Manufacturing Practice (“GMP”) certificate will follow the remaining validity period of the domestic certification.