Mandatory Reporting Mechanism for Pharmaceutical Industries and PBF Updated: Scope of Drug Materials Redefined

In 2022, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) introduced Regulation No. 2 of 2022 on the Reporting of Pharmaceutical Industry and Pharmaceutical Wholesaler Activities (“Regulation 2/2022”), which, as its title suggests, serves as a framework that addresses relevant prerequisites and procedures for pharmaceutical industries and pharmaceutical wholesalers (Pedagang Besar Farmasi – “PBF”) (collectively referred to as “Pharmaceutical Businesses”) regarding the submission of mandatory reports. Overall, Regulation 2/2022 broadly addressed the following aspects: 1) Mandatory reports on the activities of Pharmaceutical Businesses; 2) The applicable mechanisms for the reports described in point (1); and 3) Applicable sanctions.[1]