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]