BPOM Regulation Number 13 of 2026 Establishes Good Manufacturing Practice Standards for Excipients for Indonesia’s Pharmaceutical Industry

Introduction

On 30 June 2026, the Food and Drug Supervisory Agency (BPOM) issued Food and Drug Supervisory Agency Regulation Number 13 of 2026 concerning Good Manufacturing Practice Standards for Excipients Used in Drug Manufacturing (“BPOM Regulation 13/2026”), which took effect on 9 July 2026. BPOM Regulation 13/2026 was issued as the legal basis and guideline for excipient manufacturing facilities and pharmaceutical industries to ensure that the excipients used in drug manufacturing comply with the required quality standards.

The issuance of BPOM Regulation 13/2026 is based on the importance of excipients in ensuring the quality, efficacy, stability, and safety of medicinal products, as well as minimizing the risk of the circulation of medicines containing hazardous excipient contaminants. In addition, BPOM Regulation 13/2026 implements the mandate of Article 419 paragraph (2) of Government Regulation Number 28 of 2024 concerning Health, with the objective of providing legal certainty for businesses throughout the pharmaceutical industry supply chain.

Key Provisions

Obligation to Implement and Obtain Certification for Good Manufacturing Practice (GMP) for Excipients

Article 2 and Article 4 affirm that the Good Manufacturing Practice for Excipients (GMP for Excipients) standards must serve as the reference for domestic excipient manufacturing facilities as well as pharmaceutical industries in conducting supplier qualification. Compliance with these standards must be demonstrated through the possession of a GMP for Excipients Certificate. Where excipients originate from outside Indonesia, compliance with the standards may be demonstrated by equivalent documentation in the form of inspection results issued by the competent authority of the country of origin that is internationally recognized.

Furthermore, pursuant to Article 5, the obligation to possess a certificate or equivalent documentation applies only to high-risk excipients, the categories of which will be determined by the Head of BPOM.

Repackaging and the Prohibition on Sterile Excipients

Pursuant to Article 3, Pharmaceutical Wholesalers (Pedagang Besar Farmasi/PBF) for Pharmaceutical Raw Materials, including their branch offices, that carry out the repackaging and/or relabeling of excipients are required to implement the Good Manufacturing Practice for Pharmaceutical Excipients (GMP for Excipients) standards.

However, BPOM Regulation 13/2026 prohibits Pharmaceutical Wholesalers from repackaging and/or relabeling excipients that are produced and claimed as sterile excipients. Sterile excipients must be manufactured through processes that comply with the Good Manufacturing Practice for Medicinal Products (CPOB) standards for sterile preparations as stipulated under Food and Drug Supervisory Agency Regulation Number 7 of 2024 concerning Good Manufacturing Practice Standards for Medicinal Products, as amended by Food and Drug Supervisory Agency Regulation Number 7 of 2025 concerning Amendments to Food and Drug Supervisory Agency Regulation Number 7 of 2024 concerning Good Manufacturing Practice Standards for Medicinal Products.

In this context, a Pharmaceutical Wholesaler for Pharmaceutical Raw Materials is a pharmaceutical wholesaler that carries out the procurement, storage, distribution, and management of pharmaceutical raw materials, namely materials, whether active or inactive, used in the drug manufacturing process and meeting the prescribed quality standards as pharmaceutical materials.

Obligation of Pharmaceutical Industries to Conduct Quality Risk Assessments

Pursuant to Article 6, pharmaceutical industries using excipients are required to conduct quality risk assessments concerning compliance with quality aspects during the supplier qualification and validation process. Where the results of the quality risk assessment indicate that the excipient used falls within the high-risk category, the pharmaceutical industry must ensure that the supplier possesses a GMP for Excipients Certificate or equivalent documentation as evidence of compliance with the required quality standards before the excipient is used in the production process.

Administrative Sanctions

Pursuant to Article 9, BPOM Regulation 13/2026 stipulates administrative sanctions for excipient manufacturing facilities as well as pharmaceutical industries that use excipients in the manufacture of medicinal products if they fail to implement the Good Manufacturing Practice for Pharmaceutical Excipients (GMP for Excipients) standards.

The administrative sanctions that may be imposed are graduated according to the severity of the violation and its resulting impact, consisting of:

• warning;
• written warning;
• temporary suspension of activities;
• suspension of the certificate;
• revocation of the certificate;
• suspension of the business license;
• revocation of the business license;
• temporary prohibition on the distribution of excipients and/or an order to recall excipients from the market; and/or
• temporary suspension of access to the submission of business licensing applications.

Sanctions in the form of suspension and revocation of business licenses shall be imposed by the authority responsible for issuing business licenses based on the recommendation of the Head of BPOM.

The procedures for the imposition of such administrative sanctions shall be implemented in accordance with Food and Drug Supervisory Agency Regulation Number 9 of 2024 concerning Guidelines for the Follow-up of the Results of the Supervision of Medicinal Products, Pharmaceutical Raw Materials, Narcotics, Psychotropics, Precursors, and Addictive Substances, as amended by Food and Drug Supervisory Agency Regulation Number 19 of 2025 concerning Amendments to Food and Drug Supervisory Agency Regulation Number 9 of 2024 concerning Guidelines for the Follow-up of the Results of the Supervision of Medicinal Products, Pharmaceutical Raw Materials, Narcotics, Psychotropics, Precursors, and Addictive Substances.

Building and Facility Standards (Annex)

Pursuant to Chapter III of the Annex to BPOM Regulation 13/2026, the design of buildings, facilities, and production area layouts must be designed to minimize the risk of contamination, cross-contamination, and mix-ups during the excipient manufacturing process.

Furthermore, the manufacture of materials with a high potential to cause sensitization, such as allergens, as well as toxic materials, including herbicides and pesticides, must be carried out in dedicated facilities or by using equipment that is physically separated from facilities used for the manufacture of pharmaceutical excipients.

Quality Testing and Certificate of Analysis (Annex)

Pursuant to Chapter V of the Annex to BPOM Regulation 13/2026, every material used in the manufacture of excipients must undergo testing to ensure compliance with the prescribed specifications. Such testing must be conducted in accordance with the Indonesian Pharmacopoeia or other recognized international compendial standards.

In addition, all laboratory test results for each production batch must be documented and fully stated in a Certificate of Analysis (CoA) as a means of ensuring product traceability and quality assurance.

Transitional Provisions

Article 10 provides a transitional period for businesses to adjust their operational activities and comply with the certification requirements under BPOM Regulation 13/2026. Such adjustments must be completed no later than 3 (three) years from the date the Regulation was promulgated, namely by 9 July 2029.

Closing

BPOM Regulation 13/2026 governs the quality of excipients as one of the fundamental components in the manufacture of medicinal products. Through the regulation of the implementation of Good Manufacturing Practice for Excipients (GMP for Excipients) standards, certification obligations, the strengthening of supplier qualification processes based on risk assessments, and the implementation of production facility and quality testing standards.

On the other hand, BPOM Regulation 13/2026 also strengthens the enforcement mechanism through the regulation of graduated administrative sanctions, accompanied by the provision of a transitional period until 9 July 2029 to provide businesses with sufficient time to comply with all prescribed requirements. The transitional period should be utilized by excipient manufacturing facilities, Pharmaceutical Wholesalers for Pharmaceutical Raw Materials, and pharmaceutical industries to adjust their quality systems, obtain the required certifications, evaluate suppliers, and improve their operational procedures in accordance with the GMP for Excipients standards.

Nevertheless, the effectiveness of the implementation of BPOM Regulation 13/2026 remains dependent upon the issuance of further technical provisions, particularly concerning the determination of the categories of high-risk excipients that will be subject to the certification requirement. Therefore, businesses should closely monitor further developments relating to BPOM Regulation 13/2026 and prepare compliance measures at an early stage in order to minimize legal, operational, and business risks following the expiry of the transitional period.