Drug Registration Procedures Updated: BPOM Releases List of 11 Biological Products and Expands Evaluation Pathways

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, which was subsequently amended several times, most recently through the issuance of Regulation of the BPOM No. 15 of 2023 (collectively referred to as  “ Regulation 24/2017 ”). [1] In essence, Regulation 24/2017 has been serving as the framework for the overall management of drug registrations.