Human Cell-Based Medicines: Assessment Requirements and Procedures Finally Introduced

In order to ensure the quality, efficacy and safety of human cell-based medicines (“ Cell-Based Medicines ”) which are being aimed at distribution within Indonesian jurisdiction, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan– “ BPOM ”) recently issued Regulation No. 18 of 2020 (“ Regulation 18/2020 ”), which sets out extensive guidelines for the following purposes: [1]