BPOM Plans to Require 33 Types of Information to Be Included in Drug Product Information to Prevent Misuse of Drugs

Among the various mandates that feature under Regulation of the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) No. 24 of 2017 on Criteria for and the Governance of the Registration of Drugs, as amended several times, most recently through Regulation of BPOM No. 15 of 2023 (collectively referred to as “Regulation 24/2017”),[1] the evaluation of information and labeling of drug products (“Products”) should be carried out in reference to various matters, including drug information standards (“Information Standards”) that are stipulated by the Head of BPOM.[2]

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