Indonesia Regulatory News

The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, BPOM) has held a public consultation on the Draft Regulation on Certification of Good Manufacturing Practices for Cosmetics (CPKB), as part of ongoing efforts to modernize and strengthen regulatory oversight of the cosmetics sector. Stakeholders were invited to submit written comments until 26 September 2025.

The draft regulation seeks to replace BPOM Regulation No. 33/2021, introducing a risk-based supervision system, streamlining certification procedures, and codifying 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, and valid for five years.
• Certificate of Compliance with CPKB Aspects - Intended for non-contract manufacturers, offered as Gradual Type A (covering 10 quality-system aspects) or Type B (covering baseline aspects). This certificate may cover multiple dosage forms and is also valid for five years.

Applications must be submitted online. BPOM will verify documentation within seven working days. Following payment, inspections are coordinated within 20 days, and decisions are issued within 35 days for cases that do not require inspection. The process follows a “clock on/off” principle, allowing up to three data-request cycles of 20 days each.

Administrative changes, such as name or address change without relocation, can be approved without inspection. Certain technical changes and renewals may trigger inspection depending on risk level and recent oversight history. Late renewals must re-apply as new.

Existing CPKB or Aspect certificates and joint-use approvals remain valid until their expiry date. Floor-plan pre-approvals submitted before the new rule takes effect will be processed under Regulation 33/2021, signalling the elimination of this requirement in the new framework. Upon entry into force, Regulation 33/2021 will be repealed.

Why It Matters for Industry

• Predictable timelines via codified milestones of seven-, twenty-, and thirty-five-days reduce uncertainty and idle time during processing.
• 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.