If it is ultimately enforced, then this Draft Regulation (Draft Regulation) will ultimately serve as a whole new framework for the Certification of Good Cosmetics Manufacturing Practices (Cara Pembuatan Kosmetika yang Baik CPKB), replacing the previous framework of Regulation of the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan/BPOM) No. 33 of 2021. Moreover, in addition to the inclusion of quasi-drugs under a new joint-production facility scheme, this Draft Regulation simplifies the CPKB certification process while simultaneously tightening enforcement efforts through the introduction of broader administrative sanctions in the form of temporary closures of online access for submissions of notification applications and the suspension of issued certification.

As of 18 September 2025, the Regulation of the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan BPOM) No. 16 of 2024 on Contamination Limits for Cosmetics Products (Regulation 16/2024) has officially come into force. Issued in September 2024, Regulation 16/2024 provided a year for which require businesses across the cosmetics sector to ensure full alignment with the updated requirements

The framework of Regulation 24/2025 clarifies the scope of products that are defined as New Drug Development (Obat Pengembangan Baru OPB), as well as the various types of business actors that are eligible to submit applications to secure OPB approvals (Approvals). Said business actors now include hospitals and cell and/or stem-cell processing facilities/laboratories. Furthermore, in addition to redefining the applicable phases that relate to the development of new drugs and that ultimately lead to assessments of OPB (Assessments), Regulation 24/2025 also clarifies that Approvals have a five-year validity period from their dates of issuance.

Under this new regulatory framework, the halal certification process for Micro- and Small-Scale Business Actors (Usaha Mikro dan Kecil UMK) involves a self-declaration mechanism that has now been revised to include stricter eligibility and compliance requirements. In this regard, UMK must now have annual sales figures that do not exceed Rp. 15 billion and must also fulfill an expanded set of application obligations that encompass documentation, halal ingredients, product naming and labeling. UMK must also ensure that they engage in production processes that are capable of guaranteeing hygiene, strict separation from haram materials and ongoing conformity with halal standards.

Although the procedures for the mandatory registration of drugs (Registration) for medicinal products that contain biological substances (Biological Products) are already outlined under Regulation 24/2017, the Fifth Amendment has now clarified that there are 11 officially designated types of Biological Products (e.g. enzymes, monoclonal antibodies, vaccines and so forth) and also that these various products may be produced conventionally or via methods that involve biotechnology. Moreover, this Fifth Amendment also newly includes five-day and 20-day evaluations of Registration process (Evaluation Pathways) schemes, which include drugs that have been designated with Emergency Use Authorization (EUA) status.

Regulation the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan "BPOM") No. 19 of 2025 ("Amendment") on the Amendment to Regulation No. 9 of 2024 has now expanded the supervision of addictive substances by including electronic cigarettes and widening oversight across all business actors operating within the supply chain.

Regulation 18/2025 marks a major shift in the supervision of tobacco and electronic cigarette products by expanding oversight to include disclosures of ingredients, restrictions on additives and mandatory dual-lab testing. The new framework also introduces stricter labeling rules, including five rotating health warnings per variant that must cover 50% of key packaging areas. Labels must also clearly state age and pregnancy restrictions. For e-cigarettes specifically, producers must include nicotine warnings and avoid misleading terms, thereby ensuring transparency and compliance across all product types.

While maintaining the obligation for businesses operating within the cosmetics sector ("Businesses") to ensure that all manufactured and/or imported cosmetics that will be distributed within Indonesia are in compliance with relevant safety and efficacy requirements, specifically cosmetics contamination ("Contamination") limits, the new framework also now specifies that Businesses comprise the following types of entities: 1) Manufacturers of cosmetics products operating within Indonesia; 2) Individuals or business entities operating within Indonesia that operate under production contracts with manufacturers of cosmetics products; and 3) Importers operating within the cosmetics sector.

Regulation 3/2025 introduces a renewed disciplinary framework that now applies not only to doctors and dentists but also to other types of healthcare professionals. Complaints must now be submitted via the National Health Information System (Sistem Informasi Kesehatan Nasional/SIKN) within three years of any incident and should be supported by adequate evidence of a patient-provider relationship. Where online submission is not feasible, manual filing with the Professional Disciplinary Council (Majelis Disiplin Profesi/MDP) remains available. Respondents are given five working days which to offer a response, while examinations must be concluded within 60 calendar days

Stability testing is categorized into six types based on product characteristics. Batch selection requires at least two batches of the same formula to be selected in order to ensure dosage and packaging consistency. Specifications include physical, chemical and microbiological tests. Testing should follow real-time and accelerated schedules at designated intervals, while matrixing and bracketing reduction designs are used to estimate shelf life. Products must be tested under appropriate storage conditions, with due consideration being paid to temperature and humidity. Stability tests apply to both primary and secondary packaging, which are classified as impermeable or permeable based on their resistance to moisture. All findings must be documented as part of a standardized stability testing protocol.