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”).