New Drug Development Assessment Procedure Further Clarified: BPOM Approvals Now Valid for Five Years

In 2015, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) introduced Regulation of the Head of BPOM No. 16 of 2015 (“Regulation 16/2015”) on Procedures for and Assessments of New Drug Development (Obat Pengembangan Baru – “OPB”), which outlined a mechanism for OPB assessments (“Assessments”) along with various stages of drug development. However, in an effort to ensure that the applicable Assessment mechanism is in line with current legal requirements and to also encourage further scientific and technological advances within the pharmaceutical sector, BPOM has now decided to issue Regulation No. 24 of 2025, (“Regulation 24/2025”), which bears the same title as Regulation 16/2015. This new framework officially came into force on 20 August 2025.[1]