BPOM Issues New Standards and/or Quality Requirements for Drugs and Drug Materials

In a bid to protect the general public from unsafe, substandard and counterfeit drugs, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) has issued Regulation No. 23 of 2022 on Standards and/or Quality Requirements for Drugs and Drug Materials.[1] As its title suggests, Regulation 23/2022 sets applicable new standards and/or quality requirements for drugs and drug materials (collectively referred to as “Standards”) that must be complied with by relevant distribution license (“License”) holders.

Against the above backdrop, this edition of Indonesian Legal Brief offers an elaboration of the provisions that feature under the new framework of Regulation 23/2022, specifically as they relate to the following matters:

1. Fulfillment of Standards;
2. Implementation of international standards; and
3. Transitional provisions.

Fulfillment of Standards

Pursuant to Regulation 23/2022, all drugs and drug materials (collectively referred to as “Drugs”) that are produced and/or distributed by License holders are required to fulfill the official Standards, which comprise the following:[2]......