Accredited Research Institutions Now Able to Engage in Outsourced Drug Manufacturing

Up until 2022, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) established various sets of guidelines that set standards for drugs and drug materials (collectively referred to as “Drugs”), as well as pharmaceutical precursors. These standards were outlined under the following frameworks:

1. Regulation of the Head of BPOM No. 40 of 2013 (“Regulation 40/2013”) on Guidelines for the Management for Pharmaceutical Precursors and Drugs Containing Pharmaceutical Precursors (collectively referred to as “Pharmaceutical Precursors”); and
2. Regulation of BPOM No. 34 of 2018 (“Regulation 34/2018”) on Guidelines for Good Manufacturing Practices for Drugs (Cara Pembuatan Obat yang Baik – “CPOB”).[1]