BPOM Prepares New Simplified OPB Assessment Process and Clearer Document Standards for Easier Submissions

Back in 2015, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) set out various provisions that specifically addressed the mechanism for assessments of Newly Developed Drugs (Obat Pengembangan Baru – “OPB”), as well as related reporting obligations and fees for assessment applications through the issuance of BPOM Regulation No. 16 of 2015 (“Regulation 16/2015”). However, as Regulation 16/2015 is no longer relevant to current legal requirements and scientific and technological developments within the pharmaceutical sector, the BPOM is currently preparing a Draft Regulation on the Assessment Procedure for Newly Developed Drugs (“Draft Regulation”), which will repeal and replace Regulation 16/2015 if it is ultimately enforced.[1]