BPOM Introduces Guidelines for Efficacy and Safety Assessments of Anti-Bacterial Drugs

In a bid to protect the general public from the distribution of low-quality anti-bacterial drugs (“Drugs”), the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) has issued Regulation No. 8 of 2023 on Guidelines for Efficacy and Safety Assessments of Anti-Bacterial Drugs (“Regulation 8/2023”).[1] The new guidelines for assessing the efficacy and safety of Drugs (“Guidelines”), as outlined comprehensively under the Appendix to Regulation 8/2023, apply to registrations and/or re-assessments of Drugs that are distributed across Indonesian territory.[2]