BPOM Set to Update Procedures for Securing of Clinical-Testing Implementation Approvals

In response to recent legal and scientific developments within the food and drugs supervision sector, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) is currently in the process of preparing a Draft Regulation on Procedures for Clinical-Testing Implementation Approvals (“Draft Regulation”).[1] When it’s promulgated and finally comes into force, the Draft Regulation will set out updated procedures for the securing of clinical-testing implementation approvals (persetujuan pelaksanan uji klink – “PPUK”) and will repeal and replace the following legal frameworks:[2]