Regulation No. 33 of 2025 on the Assessment of Compliance with Good Manufacturing Practices (“GMP”) for Imported Drug Manufacturing Facilities (“Regulation No. 33/2025”) has entered into force and replaces the previous framework under National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan or “BPOM”) Regulation No. 7 of 2019. The regulation refines Indonesia’s approach to GMP assessments for overseas manufacturers supplying pharmaceutical products into the domestic market. While not a fundamental departure from the prior regime, it introduces notable procedural recalibrations affecting foreign manufacturers and Indonesian marketing authorization holders.

Regulation No. 33/2025 structures GMP assessment into three principal elements: (i) document assessment, (ii) desktop inspection, and (iii) on-site facility inspection. Under the previous regime, CAPA evaluation was expressly identified as a distinct component of the assessment. The new framework integrates CAPA within the broader assessment structure, reflecting procedural streamlining rather than reduced scrutiny.

A significant revision concerns the Site Master File (SMF), which must now have an effective date within the preceding one-year period (or have been reviewed within that timeframe). Previously, under the Dokumen Induk Industri Farmasi (DIIF) regime, validity extended to two years. This change elevates documentation currency standards and reinforces continuous quality governance.

For facilities in jurisdictions subject to a Mutual Recognition Arrangement (MRA) with Indonesia, applicants are required to submit a valid GMP certificate and a complete inspection report issued within the previous two years. The regulation also introduces a three-working-day document verification mechanism under a “time-to-respond” system, with the review timeline suspended pending additional submissions where required.

Ultimately, Regulation No. 33/2025 enhances procedural clarity while elevating documentary and compliance expectations. With the regulation now in effect, imported drug manufacturers and Indonesian marketing authorization holders should align documentation cycles, CAPA management practices, and regulatory coordination to ensure sustained compliance under the updated GMP assessment framework.