The Government has pushed back the halal certification deadline for micro and small enterprises? food, beverages and slaughtered products, and for several non-food product groups such as herbal medicines, health supplements, cosmetics and class A medical devices, from 17 October 2026 to 17 October 2028. The obligation for foreign-origin food and beverage products and for related services will start on 18 October 2028.

Pharmaceutical wholesalers, electronic system operators/electronic trading system operators and pharmaceutical management facilities must now hold a Good Drug Distribution Practice (Cara Distribusi Obat yang Baik ? ?CDOB?) Certificate before operating, while renewal applications must be filed twelve to six months before expiry for CDOB and six to four months for Good Drug Manufacturing Practice (Cara Pembuatan Obat yang Baik ? ?CPOB?).

The Draft Decree sets out criteria for classifying drug recalls into three classes based on health risk. Class I covers drugs that may cause death or serious health effects, as well as drugs distributed without a valid marketing authorization. Class II covers drugs that may cause temporary and reversible health effects. Class III covers drugs that pose no significant health hazard. The criteria will serve as a reference for license holders and BPOM supervisors in carrying out drug recalls.

Decree 328/2026 establishes procedures for Halal Product Assurance for foreign products before shipment to Indonesia, covering Importer registration and documentation, payment and inspection timelines, and verification of halal labels, non-halal statements, and Foreign Halal Certificate (Sertifikat Halal Luar Negeri/SHLN). For certain animal-origin products, inspections also cover contamination risks and slaughtering documents before the Halal Product Assurance Report (Laporan Pemastian Produk Halal/LPPH) is issued by the Inspection Institution.

The Constitutional Court (Mahkamah Konstitusi ? ?MK?) has pronounced four decisions business actors should watch. Business actors must now display color labels and symbols on packaged food and beverages containing sugar, salt, and fat. The Government may only terminate access after issuing a digital notification or written notice with reasons. The MK also clarified the forum for contested bankruptcy claims and interpreted ?Level II Region? for consumer dispute agencies as "regency/municipality".

The Draft Regulation expands the Food Additives (Bahan Tambahan Pangan ? ?BTP?) framework to 28 groups with maximum limits based on BTP type and food category, while tightening requirements for carry-over BTP, adjuvant use, mixtures, and specified BTP uses requiring The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan/BPOM) approval. BTP use must be supported by a quantitative certificate of analysis, while BTP production, import, and distribution are subject to licensing and administrative sanction requirements, with a 24-month adjustment period.

The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan ? ?BPOM?) is preparing a Draft Regulation under which preclinical trials on natural medicines, quasi-medicines and health supplements conducted within Indonesia must obtain a Preclinical Trial Implementation Approval (Persetujuan Pelaksanaan Uji Praklinik ? ?PPUPK?), while a PPUPK may be applied for in respect of cosmetics. BPOM will evaluate applications within 20 business days under a time-to-respond mechanism, and a PPUPK will be valid for two years.

This Decree establishes nine criteria and seven categories of products and materials that may be exempted from halal certification obligations, including products and materials that are unprocessed or subject only to minimal processing. Business actors may still be required to provide supporting documents for halal inspection and/or testing, while genetically modified plant-based materials remain subject to applicable food safety requirements.

Decree of the Minister of Health No. HK.01.07/MENKES/951/2026 establishes a comprehensive compliance framework for software-based medical devices, requiring manufacturers and distributors to meet licensing, quality management, and lifecycle risk management standards. Imported medium- to high-risk artificial intelligence-based software is subject to local clinical validation.

The Draft Decree introduces a standardized alternative method for calculating the Nutritional Value Information (Informasi Nilai Gizi/ING) based on product formulations, ingredient weights, processing methods, and oil absorption factors where laboratory testing is unavailable. Producers must also calculate and round nutritional values per serving and Percentage of Nutritional Adequacy (Persentase Angka Kecukupan Gizi/%AKG) based on Nutritional Label Reference Value (Acuan Label Gizi/ALG), with a 24-month grace period for compliance.