Indonesia Concludes Public Consultation on New CPKB Certification Rule: Risk-Based Oversight, Faster Timelines, Clearer Renewal Paths

Jakarta, September 2025. Badan Pengawas Obat dan Makanan (BPOM) has closed its public consultation on the Draft Regulation on Certification of Good Manufacturing Practices for Cosmetics (CPKB). Stakeholders were invited to submit written comments until 26 September 2025. The draft aims to replace BPOM Regulation No. 33/2021, strengthen risk-based supervision, streamline procedures, and codify service-level timelines for verification, inspections, and decisions.

What the Draft Changes

Two certification tracks.

• CPKB Certificate — required for manufacturers (including contract manufacturers), issued per dosage form, valid five years.
• Certificate of Compliance with CPKB Aspects — for non-contract manufacturers, offered as Gradual Type A (10 quality-system aspects) or Type B (focused baseline); may cover multiple dosage forms, valid five years.

Digital workflow and service clocks.
Applications are filed online; BPOM conducts document verification within seven working days. After payment, BPOM coordinates inspections within 20 days and issues decisions within 35 days for cases not requiring inspection. Processing follows “clock on/off” rules with up to three data-request cycles of 20 days each.

Renewals and changes (risk-based).
Administrative changes (e.g., name/address without relocation) can be decided without inspection. Certain technical changes and renewals may trigger inspection depending on risk and recent oversight history. Late renewals must re-apply as new.

Joint-use of facilities (Obat Kuasi/PKRT).
Cosmetic facilities may share production lines with quasi-drugs (Obat Kuasi) and/or household health supplies (PKRT) with prior approval, backed by cleaning validation and capacity documentation. Approvals follow the validity of the CPKB certificate.

Sanctions and enforcement.
Graduated measures include written warnings, temporary suspension (up to one year), freezing or revocation of certificates, and temporary closure of online access for notifications and certifications (up to one year).

Transitional rules.
Existing CPKB/Aspect certificates and joint-use approvals remain valid until expiry. Floor-plan pre-approvals submitted before the new rule takes effect are processed under Regulation 33/2021, signalling removal of this step going forward. Upon entry into force, Regulation 33/2021 will be repealed.

Why It Matters for Industry

• Predictable timelines via codified seven-, twenty-, and thirty-five-day milestones reduce processing uncertainty and idle time.
• Scalable pathways for SMEs through Aspect-Compliance options (Type A/B) provide staged on-ramps toward full CPKB.
• Risk-based renewals/changes target inspections where they add value, limiting disruption for compliant sites.
• Integrated operations enabled by formalized joint-use approvals across cosmetics, Obat Kuasi, and PKRT.

What Companies Should Do Next

1. Map your certification path (full CPKB vs Aspect Compliance A/B) and confirm dosage forms requiring certification.
2. Align dossiers and QMS with the draft’s annexed checklists; prepare for electronic submissions and clock on/off interactions.
3. Plan for renewals and changes using risk triggers to avoid unnecessary inspections and downtime.
4. Evaluate joint-use feasibility (Obat Kuasi/PKRT) and assemble validation evidence if pursuing shared lines.

Context and Next Steps

Grounded in Government Regulation No. 28/2024 under the 2023 Health Law, the draft modernizes CPKB governance by emphasizing risk management, digital administration, and enforceable service levels. With consultation closed, stakeholders should monitor BPOM for the consolidated final text and effective date.