This new Regulation represents a comprehensive reform of Indonesia?s health supplies framework through the consolidation and replacement of a number of previous Regulations under a single unified regime. This new framework will now affect pharmaceutical wholesalers, manufacturers, importers, healthcare service facilities, pharmacies and retailers. The new unified regime expands pharmaceutical distribution and dispensing mechanisms through broader retail access for certain products and enhanced real-time monitoring obligations through the National Health Information System (SIKN). In addition, the new framework also strengthens domestic sourcing priorities, revises pharmaceutical pricing controls and imposes stricter administrative sanctions.

This Regulation expands the regulatory scope of the oversight of drug advertising to now include broader promotional activities and also introduces various promotional requirements, including product eligibility, audience restrictions and mandatory risk management systems. This oversight applies not only to pharmaceutical industries but also to pharmaceutical wholesalers, pharmaceutical service facilities and organizers of electronic pharmaceutical systems.

The Indonesian Food and Drug Authority is currently preparing a Draft Regulation that will set out procedures for the issuance of Export Certificates (Surat Keterangan Ekspor - ?SKE?) for natural medicines, quasi drugs, health supplements and cosmetic products. In addition to outlining various types of SKE, the new Draft Regulation also addresses account registrations, the submission of supporting documents, application limits, validity periods and technical evaluation timelines for SKE applications.

This new Regulation standardizes the implementation of the Free Nutritious Meals Program by requiring all meal packages to be formulated based on nutritional adequacy benchmarks, balanced nutritional principles, the availability of local food products and food-safety requirements. The Nutrition Fulfillment Service Unit (Satuan Pelayanan Pemenuhan Gizi/SPPG) must prepare target-group-specific menus, provide alternatives for pupils with certain dietary restrictions, and comply with various internal and external supervision mechanisms, with non-compliance potentially leading to the imposition of administrative sanctions.

This Regulation simplifies the Good Cosmetics Manufacturing Practices (Cara Pembuatan Kosmetika yang Baik ? ?CPKB?) framework by integrating the certification process into the Online Single Submission (OSS) system and removing the securing of building floor-plan approvals as a separate requirement. In addition to revised timelines and extended renewal deadlines, this Regulation also places stricter limitations on CPKB aspect fulfillment certificates, including a prohibition on contract manufacturing and reduced renewal opportunities.

This Draft Regulation is set to expand the oversight regime that applies to natural medicines, quasi-drugs, health supplements and cosmetics across the full product lifecycle, including clinical trials and pharmacovigilance. Furthermore, additional oversights will also be introduced in relation to importation, advertising and compliance with safety, efficacy and quality standards. The sanctions regime will also soon be expanded through the introduction of various measures, including import restrictions, suspensions of clinical trials and the shutting down of electronic systems, thereby significantly increasing enforcement exposure for non-compliant businesses.

This Decree officially mandates the affixation of nutritional labels and health warnings in line with the new Nutri-Level classifications to ready-to-eat processed food products, particularly beverages (?Beverage Products?). This new mandate will be implemented gradually and will initially target large-scale businesses that are involved in the manufacture and/or distribution of Beverage Products. In this regard, the new Decree affirms that the affixation of Nutri-Level information remains voluntary in nature but will become mandatory within two years of the government introducing official sugar, salt and fat (Gula, Garam dan Lemak/GGL) thresholds for processed food products.

This new framework streamlines Indonesia?s disease control regime by consolidating a number of previous Regulations under a single, more comprehensive framework that is in line with existing health laws. The new Regulation introduces the ?One Health? system, which represents a more structured approach to immunization, as well as stricter controls over the consumption of Sugar, Salt and Fat (Gula, Garam dan Lemak/GGL) and the integration of various climate-change-related considerations into the government?s overall health framework. As a result, healthcare stakeholders will now face broader regulatory responsibilities and should take timely steps in order to ensure their compliance.

If ultimately enforced, then this Draft Regulation will offer clear guidance regarding the labeling of products containing non-halal materials or that are produced through non-halal processes. The Draft Regulation applies various criteria based on materials and production processes and also regulates the placement of and visual standards for non-halal information. In addition, the new framework provides exceptions or alternative formats for specific products or products that are sold in small packaging.

The Amendment now makes a clear distinction in terms of the oversight and regulatory authorities of both the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan/BPOM) for processed foods (pangan olahan) and the National Food Agency (Badan Pangan Nasional/Bapanas) for fresh produce (pangan segar). In addition to affirming that various businesses (e.g. manufacturers of ready-to-eat processed food and growers of fresh produce) are required to secure business permits, the Amendment has now expanded the scope of the prohibition on the distribution of contaminated food to also apply to parties that manufacture said contaminated food.