Regulation of the Food and Drug Supervisory Agency Number 33 of 2025 Tightens the Assessment of Imported Drug Manufacturing Facilities

Introduction

On 29 December 2025, the Food and Drug Supervisory Agency (“BPOM”) issued Regulation of the Food and Drug Supervisory Agency Number 33 of 2025 on the Assessment of Compliance with Good Manufacturing Practice Requirements for Imported Drug Manufacturing Facilities (“BPOM Regulation 33/2025”), which took effect on 31 December 2025. This Regulation governs the mechanism for assessing compliance with Good Manufacturing Practice (“GMP”) standards for overseas facilities that manufacture drugs to be registered and distributed in Indonesia.

BPOM Regulation 33/2025 is established to ensure that imported drugs circulating in the community consistently meet standards of safety, efficacy, and quality through a stringent evaluation of their manufacturing facilities. Through this regulation, the Government aims to provide more optimal public protection by strengthening the assessment of foreign production facilities, starting from the registration stage through to post-market supervision.

 

Comparison

BPOM Regulation 33/2025 revokes and replaces Regulation of the Food and Drug Supervisory Agency Number 7 of 2019 on the Assessment of Compliance with Good Manufacturing Practice Requirements for Imported Drug Manufacturing Facilities (“BPOM Regulation 7/2019”). The following is a comparison between BPOM Regulation 33/2025 and BPOM Regulation 7/2019:

 

Key Provisions

Tiered Assessment Mechanism

The assessment of GMP compliance for imported facilities is conducted through tiered stages, starting from document assessment, Desktop Inspection (remote document-based inspection), and continuing to on-site inspections of the manufacturing facility. Pursuant to Article 6, applications may only be submitted by Applicants who have completed the Drug Registration process. Article 12 provides that BPOM shall evaluate the initial documents to determine whether the facility is directly deemed compliant or requires further examination in the form of a Desktop Inspection or an on-site inspection.

Documentation Requirements

In submitting an assessment application, the Applicant is required to complete comprehensive registration documents. Article 6 (4) specifies that such documents include:

1. A pharmaceutical manufacturing license and a valid GMP certificate issued by the relevant local authority and/or other countries;
2. The most recent inspection report (maximum 2 years);
3. Evidence of implementation of corrective and preventive actions (CAPA) in response to findings from previous inspections;
4. A Site Master File (SMF) document with a maximum validity of 1 year; and
5. A history of sanctions, recalls, and product quality defects within the last 3 years.

Time Limits for Inspection Applications

Under Article 13, if the evaluation results require a Desktop Inspection, the Applicant must submit an application no later than 80 days after the issuance of the evaluation results. A similar requirement applies to on-site inspections; Article 22 (1) stipulates that where an on-site inspection is required, the application must be submitted within 80 days (if the decision is made directly from the initial evaluation) or 10 days (if the decision results from a Desktop Inspection). Failure to comply with these time limits results in the cancellation of the application.

Post-Market Supervision of Facilities (“During Distribution”)

BPOM Regulation 33/2025 strengthens BPOM’s authority to reassess drug manufacturing facilities whose products are already distributed in Indonesia. Article 32 (2) provides that such reassessment is based on risk-based surveillance or the existence of suspected cases relating to safety, efficacy, and quality. In this process, the marketing authorization holder is required to submit updated documents, including annual product quality reviews for the last 2 years, process validation, and environmental monitoring trend data, as regulated in Article 32 (5).

Sanctions

Article 40 (2) details the administrative sanctions that may be imposed on Applicants or marketing authorization holders who violate the provisions, which include:

1. Warning;
2. Written warning;
3. Temporary suspension of activities;
4. Suspension or revocation of the drug marketing authorization;
5. Temporary prohibition on distribution and/or an order to recall drugs from circulation; and/or
6. Temporary closure of access to the submission of business licensing applications.

 

Transitional Provisions

Based on Article 41 (1), decisions on compliance with GMP requirements for imported facilities issued prior to 31 December 2025 remain valid until the expiry of their validity period. However, for assessment applications that are in process (already submitted but not yet decided) as of 31 December 2025, the process shall continue to be conducted in accordance with BPOM Regulation 7/2019.

 

Closing

BPOM Regulation 33/2025 introduces significant consequences for importers and the pharmaceutical industry, particularly with respect to more detailed documentation compliance obligations and the risk of more severe sanctions. Businesses are now required to ensure the validity of GMP decisions, which are limited to a maximum of 2 years, and to be prepared for audits at any time even after products have entered the market. Businesses also face the risk of revocation of marketing authorizations and temporary closure of access to business licensing if they fail to comply with the requirements or deadlines stipulated under this new regulation.