BPOM Updates Provisions on Drug Registrations: Groupings of Variation Registrations Introduced

In 2017, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan –“ BPOM ”) issued Regulation No. 24 of 2017 on Criteria for and the Governance of the Registration of Drugs (“ Regulation 24/2017 ”), which, as its title suggests, currently serves as the framework for the overall governance of drug registrations. BPOM subsequently amended Regulation 24/2017 several times, with the third such amendment to this framework being Regulation of BPOM No. 13 of 2021 (Regulation 24/2017 and all amendments up until the third amendment are hereby collectively referred to as “ Regulation 24/2017 ”).