Draft Decree on Drug Recall Classification: Three Recall Classes Set for Drugs with Safety, Quality, and Marketing Authorization Issues

The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan– “ BPOM ”) is currently preparing a new Draft Decree on Criteria for the Classification of Drug Recall Classes (“ Draft Decree ”). The Draft Decree is intended to implement Regulation of BPOM No. 12 of 2026 on the Recall and Destruction of Drugs and/or Medicinal Ingredients that Do Not Meet Safety, Efficacy, Quality, Label and/or Product Information Standards and/or Requirements. [1]