The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – BPOM) has released a Draft Regulation on the Certification of Good Cosmetics Manufacturing Practices (Cara Pembuatan Kosmetika yang Baik – CPKB) in 2025. While the Draft Regulation has not yet been formally enacted, it represents one of the most significant developments in Indonesia’s cosmetics regulatory landscape since the issuance of BPOM Regulation No. 33 of 2021.

This new Draft framework reflects BPOM’s commitment to align Indonesia’s cosmetics manufacturing standards with the country’s updated national health framework, following the enactment of Law No. 17 of 2023 on Health and Government Regulation No. 28 of 2024. These overarching laws mark a shift toward a more integrated, risk-based, and technology-driven health regulatory system, and the upcoming CPKB Regulation forms part of that modernization effort.

Once officially enacted, the 2025 Draft Regulation will repeal and replace BPOM Regulation No. 33 of 2021, introducing simplified certification procedures, expanded administrative sanctions, and an extended certification scope that now includes quasi-drugs (produk kuasi-obat) in addition to conventional cosmetic products. This expansion acknowledges the growing intersection between cosmetics, pharmaceuticals, and household health products (Perbekalan Kesehatan Rumah Tangga – PKRT), which increasingly share similar facilities, formulations, and quality control systems.

From a regulatory perspective, the Draft aims to reduce bureaucratic complexity in the certification process by eliminating redundant approval steps such as building plan verification and shared facility authorization. Simultaneously, BPOM is strengthening enforcement mechanisms by introducing new administrative sanctions, including the suspension of certification and temporary closure of online access to submission systems, to enhance accountability among manufacturers.

From an industry standpoint, the Draft Regulation signals a transition toward greater regulatory harmonization and operational efficiency. It is expected to facilitate faster certification processing, encourage compliance readiness, and support industry players in meeting international standards for manufacturing practices. This article provides this policy overview to raise awareness among cosmetics manufacturers, importers, and regulatory professionals about the forthcoming changes proposed under the Draft Regulation, and to help businesses prepare for potential compliance implications once the regulation comes into force.

Simplification of Certification Procedures

The forthcoming Draft Regulation on Good Cosmetics Manufacturing Practices (CPKB) introduces significant procedural reforms aimed at enhancing administrative efficiency, legal certainty, and operational practicality in the certification process for cosmetics manufacturers. These changes are part of BPOM’s broader initiative to streamline regulatory requirements in line with Indonesia’s evolving risk-based licensing system and to promote a more transparent and predictable certification environment.

Under the existing framework of BPOM Regulation No. 33 of 2021, cosmetics manufacturers seeking certification are required to complete multiple pre-assessment steps before their applications can be verified. These include submitting building plan approvals (persetujuan denah bangunan) and obtaining authorization for the use of shared facilities, particularly when the same premises are used for manufacturing pharmaceuticals or traditional medicines. While these measures were initially designed to safeguard manufacturing integrity, they often led to procedural bottlenecks, extended processing timelines, and inconsistent interpretations during field verification.

The 2025 Draft Regulation removes these redundant procedural requirements, shifting the focus from administrative pre-approvals to substantive compliance verification based on actual manufacturing practices and quality management systems. This means that cosmetics manufacturers will no longer need to secure prior approvals for their facility layout or shared operations before submitting a certification application, except in specific cases involving Category B Aspect Fulfilment Certificates, where an industrial building plan remains necessary as part of the technical dossier. However, even in such cases, BPOM approval is no longer required at the submission stage.

This reform represents a deliberate move from document-heavy approval processes toward compliance-based certification, emphasizing manufacturers’ accountability for ensuring that their operations and facilities already meet the principles of Good Cosmetics Manufacturing Practices (CPKB) prior to inspection. By doing so, BPOM aims to minimize administrative delays and encourage applicants to maintain proactive internal compliance systems, rather than relying solely on regulatory pre-clearance.

Another notable procedural adjustment is the extension of the verification period for submitted applications. Under the current Regulation 33/2021, BPOM must complete the initial verification within three business days of submission. The Draft Regulation extends this timeframe to seven business days, allowing the authority to conduct more thorough document reviews and coordinate inter-departmental evaluations without compromising transparency or service predictability. This adjustment also aligns with the broader shift toward risk-based supervision, giving BPOM more flexibility in determining whether a facility requires additional inspection or documentation.

Furthermore, while the general structure of the certification system remains intact, consisting of the CPKB Certificate and the CPKB Aspect Fulfilment Certificate, the Draft Regulation introduces an important clarification regarding scope and coverage. A single Aspect Fulfilment Certificate may now apply to multiple dosage forms (bentuk sediaan), provided that the manufacturing processes and facilities are consistent across those forms. This enhancement reduces duplication, streamlines renewals, and promotes efficiency for manufacturers producing a range of cosmetics within a single certified facility.

From a business standpoint, these procedural simplifications are expected to reduce administrative costs, accelerate market entry, and enhance regulatory predictability for both domestic and foreign cosmetics manufacturers. The move also aligns Indonesia’s certification regime more closely with international good manufacturing practice (GMP) standards, fostering a competitive environment for companies that prioritize compliance and quality assurance.

In practice, these reforms position BPOM as not only a regulatory authority but also a facilitator of responsible industry growth, balancing the need for public health protection with the realities of business operations. Manufacturers and importers are encouraged to begin internal readiness assessments and ensure that their documentation, facility layouts, and quality systems are aligned with the new compliance-based approach ahead of the regulation’s official enactment.

Expansion of Joint Production Facilities

The 2025 Draft Regulation on Good Cosmetics Manufacturing Practices (CPKB) also introduces a significant regulatory evolution in the area of joint production facilities (fasilitas produksi bersama), marking a more progressive and integrated approach to manufacturing oversight within Indonesia’s cosmetics and health product sectors.

Under the existing BPOM Regulation No. 33 of 2021, cosmetics manufacturers were already permitted to share production facilities with producers of household health supplies (Produk Kesehatan Rumah Tangga – PKRT) and traditional medicine (obat tradisional) products, provided that the facility met all relevant hygiene, segregation, and operational safety requirements. However, this earlier framework was limited in scope and did not reflect the rapid advancement of multi-functional products, particularly those situated at the regulatory intersection of cosmetics, healthcare, and quasi-therapeutic formulations.

The Draft Regulation of 2025 broadens this definition substantially by including “Quasi-Drugs” (produk kuasi-obat) within the permissible scope of joint production. These are defined as preparations that contain active ingredients with local or non-systemic pharmacological effects, intended to relieve minor ailments or provide mild therapeutic benefits, such as topical antiseptics, anti-itch creams, or soothing balms. Quasi-drugs occupy a unique category between cosmetics and pharmaceuticals, reflecting global regulatory trends that acknowledge the rise of borderline products or hybrid formulations in the personal care industry.

This inclusion represents BPOM’s adaptive regulatory stance in recognizing product innovation and market convergence. The updated joint-production policy aims to streamline manufacturing oversight for facilities producing multiple product categories that share similar raw materials, production environments, and quality management systems. By doing so, BPOM seeks to minimize redundancy in inspection while maintaining strict adherence to safety and quality assurance principles.

Manufacturers that intend to utilize joint production facilities for cosmetics and quasi-drug products must obtain prior approval from the Head of BPOM, ensuring that facility sharing does not compromise product quality or compliance integrity. The approval procedure mirrors the standard CPKB certification process, encompassing application submission, documentation review, and facility inspection. However, in a forward-looking shift, the Draft Regulation allows BPOM to waive on-site inspections where sufficient evidence of compliance already exists, such as records of recent routine inspections, certification history, or validated product traceability systems. This waiver reflects BPOM’s commitment to a risk-based supervision model, optimizing regulatory resources while maintaining robust oversight.

The validity period of joint-production approvals will be tied directly to the validity of the corresponding CPKB Certificate held by the cosmetics manufacturer. In cases where multiple dosage forms (bentuk sediaan) are produced within the same facility, such as creams, gels, and powders, the validity of the joint-production approval will follow the earliest-expiring CPKB Certificate. This ensures regulatory alignment and prevents potential gaps in compliance supervision.

From an industry perspective, the expansion of joint-production permissions offers increased operational flexibility and cost efficiency for manufacturers managing integrated production lines. It allows companies to maximize facility utilization, streamline supply chain logistics, and reduce duplication of infrastructure investments, particularly for foreign principals operating through local subsidiaries or contract manufacturing organizations (CMOs).

However, the broadened allowance also places greater emphasis on internal quality management and product segregation protocols. Manufacturers must implement robust Good Manufacturing Practice (GMP)-equivalent systems across all shared production zones to prevent cross-contamination, mislabeling, or mixing of product categories.

In practical terms, the 2025 Draft Regulation reinforces BPOM’s dual objective to support innovation and industry competitiveness, while maintaining public health protection and consumer trust. It signals a clear regulatory acknowledgment that the future of Indonesia’s cosmetics sector lies in convergence-driven manufacturing ecosystems, where product diversification and regulatory compliance go hand-in-hand.

Expanded Scope of Administrative Sanctions

The 2025 Draft Regulation on Good Cosmetics Manufacturing Practices (CPKB) not only simplifies certification procedures but also reinforces BPOM’s enforcement capacity through a more comprehensive and proportionate sanctioning framework. This evolution reflects the authority’s continuing commitment to strengthening compliance discipline across Indonesia’s cosmetics manufacturing industry, while ensuring that regulatory enforcement remains consistent, transparent, and risk-based.

Under the previous BPOM Regulation No. 33 of 2021, administrative sanctions for non-compliance were limited primarily to written warnings, temporary suspensions, and revocation of certification. While these measures established a deterrent framework, they did not always provide sufficient flexibility for BPOM to apply sanctions progressively according to the severity, frequency, or intent of the violation.

The Draft Regulation of 2025 expands these enforcement tools by introducing intermediate measures and graduated sanctions, giving BPOM a wider range of corrective responses before resorting to revocation. This shift demonstrates BPOM’s transition toward a proportional enforcement model, aligning Indonesia’s cosmetics regulatory approach with global best practices in regulatory compliance management. Comparative Overview: Administrative Sanctions under Regulation 33/2021 vs. 2025 Draft Regulation:

Conclusion

The forthcoming Draft Regulation on the Certification of Good Cosmetics Manufacturing Practices (CPKB) 2025 represents a decisive step in Indonesia’s regulatory modernization under BPOM’s supervision. By simplifying certification procedures, expanding permissible joint-production facilities, and introducing a more flexible and proportional system of administrative sanctions, BPOM is reaffirming its dual mission to protect public health while supporting industrial growth and innovation within the cosmetics and quasi-drug sectors.

For cosmetics manufacturers and importers, the Draft Regulation signals a transformative shift in compliance expectations. The elimination of redundant pre-approvals, the inclusion of Quasi-Drugs within joint-production frameworks, and the establishment of new sanction mechanisms reflect BPOM’s increasing emphasis on risk-based supervision and corporate accountability.  As a result, businesses must adapt by strengthening their internal quality management systems, ensuring traceability of manufacturing processes, and maintaining alignment with CPKB principles across all operations.

While the Draft Regulation remains under public consultation until its formal enactment, early awareness and strategic preparation are essential. Manufacturers should begin reviewing their current certification status, facility sharing arrangements, and SOP documentation, as well as assessing whether their existing compliance framework will meet the forthcoming requirements once the new regulation comes into force.

At ET Consultant, we assist both local and multinational clients in navigating Indonesia’s evolving regulatory landscape. Our expertise covers the full lifecycle of BPOM compliance, from pre-assessment and document readiness reviews to CPKB certification, PKRT licensing, and regulatory representation.  We also provide regulatory monitoring services to track new BPOM policy developments, ensuring our clients remain informed and proactive amid ongoing legal reforms. With our multidisciplinary team of legal consultants, regulatory specialists, and quality compliance advisors, ET Consultant ensures that your company remains fully prepared, not only for certification but for sustainable, long-term compliance.

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ET Consultant is a Business Consultant and Legal Consultant Expert that provides support for local and multinational clients to start and manage their business operations in Indonesia. ET Consultant specializes in Business Incorporation, Licensing & Legal, Accounting & Taxes, Immigration, and Advisory Services.

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