BPOM Drafts New Regulation for Implementation of Pharmacovigilance

The National Agency of Drug and Food Control (“ BPOM ”) is currently drafting the Draft Regulation of BPOM on Implementation of Pharmacovigilance (“ RPerBPOM on Implementation of Pharmacovigilance ”). This regulation will require the pharmaceutical industry to maintain a pharmacovigilance system, monitor drug safety, and regularly report drug side effects (Efek Samping Obat- “ ESO ”) to BPOM.

“The progress is currently in the public consultation stage, seeking input from the industry,” said Taruna Ikrar, Head of BPOM, to Hukumonline.

The draft regulation of BPOM will replace Regulation of BPOM No. 15 of 2022 on Application of Pharmacovigilance (“ PerBPOM 15/2022 ”), which previously adopted global standards from the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Based on the draft obtained by Hukumonline, there are several additional provisions. One of these includes the role of distributors, importers, and exporters in exchanging safety information with distribution license holders as part of Pharmacovigilance.