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]