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.

This new Draft Regulation revises the mandatory licensing framework for producers of processed food products by strengthening the food safety compliance requirements that apply to both domestic and overseas production facilities. The compliance of overseas facilities must be evidenced through recognized certification, while domestic facilities are required to secure both Good Manufacturing Practices for Processed Foods (Cara Produksi Pangan Olahan yang Baik/CPPOB) Implementation Licenses, as well as Risk Management Program (Program Manajemen Risiko ? ?PMR?) Implementation Licenses, with the PMR obligation now being expanded to cover large-scale producers of non-high-risk foods and users of food additives. At the same time, the Draft Regulation will also introduce simplified documentation and accelerated licensing timelines for Micro- and Small-Scale Enterprises (Usaha Mikro dan Kecil/UMK), which involve post-licensing audits. Finally, the range of available administrative sanctions for non-compliance has also been broadened.

If this Draft Regulation ultimately comes into force, then it will repeal and replace Regulation of the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan/BPOM) No. 24 of 2017 on Criteria and Procedures for Drug Registrations. This will fundamentally transform Indonesia?s drug registration system through the introduction of conditional approvals, as well as the streamlining and expediting of Emergency Use Authorization (EUA) processes, and the shifting of approval notifications to a fully digital platform.

Food safety training (?Training?) is now open to both State Civil Apparatus (Aparatur Sipil Negara/ASN) employees, as well as other human resources that work within the food safety sector (?Participants?). Training may be delivered through classical, blended or job-integrated learning methods. Meanwhile, Participants must comply with established standards of conduct, with administrative sanctions being imposed in response to violations. Participants will also be subject to clearer requirements relating to the successful completion of Training, including minimum assignment scores, a prohibition on plagiarism and certain attendance thresholds.

This Regulation has been issued as a follow-up to Article 48 of Government Regulation No. 42 of 2024 on the Organization of the Halal Product Assurance Sector (Regulation 42/2024), which replaced Government Regulation No. 39 of 2021 on the Organization of the Halal Product Assurance Sector (Regulation 39/2021), in order to address technical procedures for registrations, revocations of registrations and terminations of halal auditors. Under this new framework, all services must be organized through the integrated Halal Information System (Sistem Informasi Halal - SIHALAL), with detailed timeframes being set for each stage. This new Regulation also reinforces halal auditor commitments through mandatory documentation and stipulates the various consequences that may result from violations. The procedure for the revocation of registrations can be implemented either at the request of Halal Inspection Agencies (Lembaga Pemeriksa Halal LPH) or based on supervision results of the Halal Product Assurance Organizing Agency (Badan Penyelenggara Jaminan Halal BPJPH), with differing consequences applying in either case. Meanwhile, halal auditors may be terminated by LPH under certain conditions, with BPJPH supervision results becoming the basis for any such decision. This Regulation has also strengthened the governance of halal auditors and should ensure that registration services are organized effectively, efficiently and transparently with full accountability.

This Decree establishes clearer rules on how additional health insurance may be used to cover extra costs (differential cost payments) whenever participants seek treatment above the classes that they are covered under. In this regard, said higher levels of treatment should be decided through coordination between healthcare facilities, the Social Security Administrator for Health (Badan Penyelenggara Jaminan Sosial Kesehatan BPJS Kesehatan) and additional health insurers. Specifically, cost-sharing limits have been set at 250% of the National Health Insurance Program (Jaminan Kesehatan Nasional/JKN) tariff for healthcare facilities, with BPJS Kesehatan covering 75% and additional insurers meeting the remainder of the costs up to a limit of 175%, subject to the details of individual insurance policies and any special arrangements that may exist between healthcare providers and additional health insurers.

This Decree establishes a comprehensive framework for the handling of complaints related to patient satisfaction, incidents involving patient safety and other service-quality issues that occur at Advanced Healthcare Facilities (Fasilitas Pelayanan Kesehatan Tingkat Lanjut FPKTL), including hospitals, main clinics, blood service units and medical laboratories. Complaints are classified into two categories, i.e. complaints relating to patient satisfaction and complaints relating to patient safety incidents, each with its own defined scope and a resolution timeframe of up to 45 business days. All such attempts at resolutions will follow a structured procedure. Meanwhile, any FPKTL that are ultimately found in violation may face the imposition of progressive administrative sanctions ranging from verbal and written warnings to fines, accreditation adjustments and the revocation of their business permits.

This Decree sets out a comprehensive set of guidelines that address the distribution and dispensing of Over-The-Counter (OTC) and limited OTC drugs via retail outlets such as hypermarkets, supermarkets and minimarkets. Aimed at expanding public access while maintaining overall safety and quality standards, the Decree outlines various licensing, cooperation and supervision requirements for distribution channels, establishes rules on proper dispensing practices and also promotes human resource capacity building in order to ensure responsible implementation throughout the retail sector.

In addition to pharmaceutical service facilities (Pharmaceutical Facilities), which are currently allowed to manage drugs, drug ingredients, narcotics, psychotropics and pharmaceutical precursors (collectively referred to as Drug Products), this Draft Regulation now permits other non-Pharmaceutical Facilities (Other Facilities) to provide drugs and pharmaceutical precursors. It should be noted that these Other Facilities have been limited to dealing with over-the-counter drugs (obat bebas), limited over-the-counter drugs (obat bebas terbatas) and drugs containing pharmaceutical precursors classified as limited over-the-counter drugs. Meanwhile, the Draft Regulation also newly lists several prohibitions that apply to Pharmaceutical Facilities and Other Facilities during the overall management of Drug Products, including prohibitions on the procurement and distribution of Drug Products that fail to meet safety, efficacy and/or quality requirements.

This new circular reaffirms the obligation for business actors to affix Indonesian halal labels to all halal-certified products. Said halal labels must be affixed to packaging, certain parts of products or other designated areas, while the implementation of labeling will be directly supervised by the Halal Product Guarantee Agency (Badan Penyelenggaraan Jaminan Produk Halal - BPJPH). In addition, business actors are now required to publish information on all of their halal-certified products through their electronic or social-media accounts and must also report these published links to BPJPH.