Regulation Watch · Tourism and Health · Indonesia. The regulation applies to facilities manufacturing pharmaceutical excipients in Indonesia; pharmaceutical manufacturers that qualify suppliers of excipients used in drug production; and pharmaceutical wholesalers for drug ingredients, including branches, that repackage or relabel excipients. It also affects Indonesian pharmaceutical companies sourcing excipients from foreign manufacturers.
BPOM Makes Excipient GMP Compliance Mandatory
PerBPOM 13/2026 makes good-manufacturing standards mandatory for Indonesian pharmaceutical-excipient facilities, supplier qualification by drug manufacturers and specified repackaging or relabelling by pharmaceutical wholesalers, with a three-year adjustment period.
- Published
- Established in Jakarta on 30 June 2026 and promulgated on 9 July 2026 in State Bulletin 2026 No. 459. It was first recorded by Regulation Watch on 10 October 2026 as a late-discovered instrument.
- Effective
- 9 July 2026, the date of promulgation specified by Article 11.
- Added to Watch
- 10 October 2026
Who is affected
PT PMA and PT PMDN pharmaceutical-excipient manufacturers, pharmaceutical manufacturers, pharmaceutical wholesalers for drug ingredients and their branches, Indonesian importers and users of foreign-made excipients, foreign excipient suppliers, shareholders and directors, and quality, production, procurement, warehouse, distribution, regulatory and compliance teams.
Practical impact
The regulation turns BPOM's excipient good-manufacturing standard into a mandatory operating and supplier-control framework. Indonesian excipient manufacturers must apply the standard, and compliance for high-risk excipients must be evidenced by a certificate. Pharmaceutical manufacturers must perform a documented risk assessment when qualifying each excipient supplier and require a certificate or equivalent foreign-authority evidence when the result is high risk. Drug-ingredient wholesalers that repackage or relabel excipients must follow the relevant standard and may not repackage or relabel an excipient claimed to be sterile. BPOM may inspect both manufacturing facilities and pharmaceutical manufacturers' supplier-qualification controls.
PerBPOM 13/2026 was established on 30 June 2026, promulgated on 9 July in State Bulletin 2026 No. 459 and took effect on promulgation. The instrument gives covered businesses three years to adjust, making 9 July 2029 the final transition date, but it does not state that the regulation itself is suspended until then.
The mandatory standard has three operational audiences. Facilities manufacturing pharmaceutical excipients in Indonesia must apply it to their manufacturing activities. Pharmaceutical manufacturers must use it when qualifying suppliers of excipients used in drug production. Pharmaceutical wholesalers for drug ingredients, including branches, must apply the relevant repackaging and relabelling provisions when they perform those activities.
The standard covers the full quality system: personnel, buildings and facilities, equipment, production, storage and distribution, quality control, self-inspection, complaints, recalls, returned products, disposal, documentation, outsourced activities, qualification and validation. It is designed to control the risk that excipient contamination, variability or an uncontrolled supply chain carries into a finished medicine, often without further purification.
Certification is risk-based. Indonesian excipient manufacturers must evidence compliance by certificate for excipient types placed on BPOM's high-risk list. A pharmaceutical manufacturer must perform a risk assessment when qualifying a supplier and, where the result is high risk, require that certificate or equivalent evidence. For a foreign producer, equivalent evidence may come from the local or another competent authority and may include the latest inspection record or another document confirming an internationally recognised excipient GMP standard.
Special restrictions apply to sterile claims. An excipient claimed to be sterile must meet the excipient standard and the relevant CPOB requirements for sterile-product manufacture. A pharmaceutical wholesaler for drug ingredients or its branch is prohibited from repackaging or relabelling an excipient claimed to be sterile, so the sterile supply chain and label configuration must be resolved at the approved manufacturing level.
BPOM may inspect both the excipient-manufacturing facility and the pharmaceutical manufacturer that uses the excipient. For the pharmaceutical manufacturer, inspection specifically includes whether the excipient standard is being used for supplier qualification. Procurement approval alone is therefore insufficient: the quality-risk assessment, supporting certificate or equivalent evidence, approved-supplier decision and ongoing controls should form one traceable file.
Administrative sanctions escalate from warnings and severe warnings to temporary suspension, certificate freezing or revocation, business-licence freezing or revocation, a temporary distribution ban and/or recall order, and temporary closure of access to business-licensing applications. Investors and operators should use the transition period as an implementation runway, with priority given to high-risk excipients, foreign supplier evidence, sterile claims and any repackaging or relabelling activity.
Required action
- Inventory every excipient manufactured, imported, purchased, repackaged, relabelled or used in Indonesian drug production, and identify the legal manufacturer, manufacturing site, grade, intended use, sterile claim and supply-chain intermediaries.
- Gap-assess Indonesian excipient facilities against the mandatory standard covering the quality system, personnel, buildings and facilities, equipment, production, storage and distribution, quality control, self-inspection, complaints and recalls, returns and disposal, documentation, outsourced activities, qualification and validation.
- Build a documented supplier-qualification process for every pharmaceutical-manufacturing site and complete the required excipient-quality risk assessment under the applicable BPOM drug and drug-ingredient risk rules.
- For an excipient assessed as high risk, obtain and verify the applicable BPOM or internationally recognised certificate. For a foreign producer without that certificate, retain equivalent evidence issued by the local or another competent authority, such as the latest inspection record or another document confirming compliance with an internationally recognised excipient GMP standard.
- Monitor the BPOM Head's list of high-risk excipients and update risk classifications, contracts, approved-supplier records and incoming-release controls when that list or supplier status changes.
- Stop any drug-ingredient wholesaler or branch from repackaging or relabelling an excipient claimed to be sterile; confirm that sterile-excipient production also follows the applicable sterile-product CPOB requirements.
- Place the transition programme under management oversight and preserve inspection-ready evidence, including risk assessments, audit and qualification records, certificates, foreign-equivalent documents, specifications, certificates of analysis, change controls, complaints, recalls and distribution traceability.