BPOM Draft Regulation on Drug Registrations Introduces Electronic-Based Drug Approvals and Stronger Post-Market Obligations

In 2017, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan –“ BPOM ”) introduced Regulation No. 24 of 2017 on Criteria and Procedures for Drug Registrations, as amended several times, most recently through the issuance of Regulation of BPOM No. 23 of 2025 (collectively referred to as “ Regulation 24/2017 ”). As its title suggests, Regulation 24/2017 has been serving as the framework for the overall management of drug registrations.