Regulation Watch · Tourism and Health · Indonesia. The regulation applies nationally to pharmaceutical manufacturers and other facilities making drugs or drug ingredients, including clinical-trial drugs; pharmaceutical wholesalers and branches; drug-ingredient wholesalers and branches; qualifying pharmaceutical-management facilities; and PSE or PPMSE operators that provide, manage or operate electronic systems for drug distribution.
BPOM Unifies Drug Manufacturing and Distribution Certification
PerBPOM 16/2026 replaces the separate CPOB and CDOB certification rules, brings electronic drug-distribution platforms expressly into CDOB scope and sets new renewal, facility-change and transition deadlines.
- Published
- Established in Jakarta on 3 September 2026 and promulgated on 29 September 2026 in State Bulletin 2026 No. 678.
- Effective
- 29 September 2026, the date of promulgation specified by Article 99.
- Added to Watch
- 10 October 2026
Who is affected
PT PMA and PT PMDN pharmaceutical manufacturers, contract manufacturers and clinical-trial facilities; pharmaceutical wholesalers and their branches; drug-ingredient wholesalers; e-pharmacy, marketplace and other PSE or PPMSE operators supporting drug distribution; investors, foreign and Indonesian shareholders and directors; and quality-assurance, responsible-pharmacist, licensing, technology, warehouse, distribution and compliance teams.
Practical impact
The regulation consolidates CPOB manufacturing certification and CDOB distribution certification into one procedural framework linked to OSS and BPOM systems. CPOB certification is tied to each building unit, dosage form and manufacturing process. CDOB certification is required before wholesalers, covered facilities and electronic-system operators begin the relevant drug-distribution activity, and is issued by product category and activity. Certificates are valid for up to five years, but renewal applications must be filed early: four to six months before CPOB expiry and six to twelve months before CDOB expiry. Certain facility changes require prior approval or inspection, and electronic-distribution applicants must show PSE registration, a PPMSE business licence, qualified pharmacy and technology personnel, an application business-process diagram and customer-and-supplier qualification procedures.
PerBPOM 16/2026 was established on 3 September 2026, promulgated on 29 September in State Bulletin 2026 No. 678 and took effect on promulgation. It replaces the 2011 CPOB certification procedure, the 2017 CDOB certification procedure and the specified CDOB-certification provisions of PerBPOM 20/2025.
The new framework covers both physical facilities and digital distribution. Pharmaceutical manufacturers and other facilities making drugs or drug ingredients must evidence CPOB compliance. Pharmaceutical wholesalers, branches, drug-ingredient wholesalers, covered pharmaceutical-management facilities and PSE or PPMSE operators that provide, manage or operate an electronic system for drug distribution must evidence CDOB compliance. The certificate is required before the covered activity begins.
CPOB certification is issued for each building unit according to dosage form and manufacturing process, including all or part of a process. Applications run electronically through OSS integrated with BPOM's certification service. External warehouses require BPOM approval, and specified production, storage or administrative changes must be processed through the certificate-change route rather than being treated as an internal operational decision.
CDOB certification is organised by product category and activity. For electronic distribution, the applicant's administrative evidence includes PSE registration and a PPMSE business licence. The technical file must include appropriate expertise, including at least a pharmacist and a systems or information-technology expert, the application's business-process diagram and procedures for qualifying customers and suppliers.
Both CPOB and CDOB certificates can remain valid for up to five years while the operator continues to comply. The renewal windows differ: CPOB renewal is filed between six and four months before expiry, while CDOB renewal is filed between twelve and six months before expiry. Missing the applicable window may force a new application and, once the certificate expires, prevent the affected manufacturing, procurement, supply or electronic-system activity.
The transition preserves pending CPOB and CDOB applications under the former rules and keeps existing certificates valid to their expiry. Two asset-level deadlines need immediate attention. An external-warehouse approval without an expiry date is treated as revoked and must be replaced by a new application within six months, by 29 March 2027. An existing approval for secondary packaging outside the factory becomes invalid one year after promulgation, on 29 September 2027.
Administrative sanctions range from warnings and severe warnings to temporary suspension, a temporary block on access to business-licensing applications, certificate freezing and certificate revocation. Investors and operators should therefore reconcile OSS, BPOM, facility, licence, personnel and digital-system records now, then place renewal and transitional deadlines under board-level compliance oversight.
Required action
- Map every Indonesian manufacturing building, dosage form, process, external warehouse, wholesale location and electronic drug-distribution function to the required CPOB or CDOB certificate and confirm that the NIB, business licence and BPOM records identify the same entity and activity.
- Do not start a covered manufacturing, procurement, storage, supply or electronic drug-distribution activity until the applicable certificate or BPOM facility approval is in force.
- Calendar CPOB renewal between six and four months before expiry and CDOB renewal between twelve and six months before expiry; prepare self-inspection, quality-system and CAPA evidence before those windows open.
- File certificate or account changes within the prescribed route. Update CPOB account data within one month after a data change, and obtain prior approval where the regulation classifies a facility, warehouse, product-category or system change as requiring approval or inspection.
- For a PSE or PPMSE drug-distribution model, verify PSE registration and the PPMSE business licence, appoint at least a pharmacist and a systems or information-technology expert, and document the system business process and supplier-and-customer qualification controls.
- If an existing external-warehouse approval has no expiry date, treat it as revoked and submit a new application by 29 March 2027. Plan to stop relying on an approval for secondary packaging outside the factory no later than 29 September 2027.
- Preserve the filing receipt, payment order and proof, inspection record, CAPA submissions and BPOM decision; the regulation uses short verification, payment and corrective-action clocks and paid fees are generally non-refundable.