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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 Upon entry into force, Regulation 33/2021 will be repealed.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.

Indonesia’s Ministry of Trade has issued Regulation No. 20 of 2025 on the import of chemicals, hazardous substances, and certain minerals, replacing Regulation No. 36 of 2023 (as amended). The rule was promulgated on 30 June 2025 and took effect on 29 August 2025.

Scope and Coverage

The regulation establishes import controls for the following categories:

• Non-pharmaceutical precursors, nitrocellulose (NC), industrial explosives, ozone-depleting substances (ODS/BPO), hazardous substances (B2), hydrofluorocarbons (HFCs), and certain designated chemicals (BKT) listed in the annexes. Examples in the annex materials and official briefings include commodity-grade inputs such as sodium tripolyphosphate (STPP), formic acid, and lysine and its salts, as well as numerous HFC refrigerant blends referencing components like HFC-134a and HFC-32.

Legal Basis and Key Dates

• Issued: 30 June 2025 (promulgated in the State Gazette).
• Effective: 29 August 2025 (60 days after promulgation).
• Replacing: Minister of Trade Reg. 36/2023 (as last amended by 8/2024) for the covered chemical streams.

Import Licensing and Verification

Importers must hold appropriate business permits and import approvals before goods enter Indonesia’s customs territory, using the regime defined in the regulation:

• IT (Importir Terdaftar / Registered Importer),
• IP (Importir Produsen / Producer Importer), and
• PI (Persetujuan Impor / Import Approval).

The regulation also formalizes verification/technical tracing by authorized surveyors and the issuance of Laporan Surveyor (LS) where required. Definitions for IT, IP, PI and LS are standardized in Article 1.

Electronic Realisation Reporting

Holders of PI or LS must submit electronic import realisation reports, covering both realised and unrealised volumes, in accordance with the trade licensing framework administered by the Ministry of Trade. Non-compliance triggers administrative sanctions.

Treatment in Special Regimes (FTZ/SEZ/Bonded)

The regulation distinguishes the treatment of goods entering Free Trade Zones (KPBPB), Special Economic Zones (KEK), and Bonded Warehouses (TPB):

• For BKT and certain bulk commodities (e.g., lube base stocks, cement/clinker, oil and gas), imports into TPB are not subject to import licensing/verification at entry; however, full import requirements apply when released into the domestic market.
• By contrast, ODS (BPO), HFCs, non-pharma precursors, nitrocellulose, industrial explosives, and hazardous substances (B2) are regulated upon entry into TPB, requiring import licensing and, where applicable, verification. Similar controls apply to KPBPB/KEK movements as specified in the rule.

Transitional Provisions

Existing IT/IP/PI documents remain valid until expiry and may be amended or extended under the new framework. However, previously issued PI for Certain Chemicals (BKT) under API-P/API-U are expressly revoked via the INATRADE system. Surveyor (LS) documents issued under prior rules remain valid through completion of the relevant importation.

Compliance Actions for Industry

• Map your HS codes against the annexes to determine whether your products fall under B2, ODS, HFCs, precursors, NC, explosives or BKT controls.
• Confirm permit status (IT/IP/PI) and whether LS verification applies to your line items.
• Set up reporting processes to file electronic import realisation reports for PI/LS-covered shipments.

Assess zone strategy: imports routed via TPB/KPBPB/KEK may obtain warehousing efficiencies, but domestic release will trigger full import controls; certain categories are regulated at all stages including entry.