BPOM Set to Tighten Oversight of Clinical Trials and Pharmacovigilance

The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan– “ BPOM ”) is currently completing work on a new Draft Regulation (“ Draft Regulation ”) on Guidelines for Follow-ups to Supervision Results for Natural Medicines, Quasi-Drugs, Health Supplements and Cosmetics (collectively referred to as “ Products ”). If this new framework ultimately comes into force, then it will repeal and replace Regulation of BPOM No. 19 of 2021 , which bears a similar title to the Draft Regulation (“ Regulation 19/2021 ”), as well as various provisions on procedures for the imposition of administrative sanctions, as featured under six BPOM regulatory frameworks that specifically address the aforementioned Products. [1]