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.

This Regulation requires foreign products to undergo mandatory halal product verification process before import customs declarations, with results documented in a Halal Product Verification Report. Importers must meet specified documentation requirements, while verification covers product, labelling, halal certifications, and technical documents. Inspection agencies must meet accreditation and operational requirements, with non-compliance subject to administrative sanctions.

This Draft Regulation would expand Good Drug Manufacturing Practices (Cara Pembuatan Obat yang Baik ? ?CPOB?) to other production facilities and introduce requirements for plasma-derived drug products (Produk Obat Derivat Plasma - ?PODP?), contract fractionation, traceability, look-back procedures, inventory holding times, and viral inactivation segregation. This Draft Regulation would also require Plasma Master File (PMF) documentation and one-year retention of plasma pool samples and records after finished PODP expiry.

This Amendment expands the mandatory Indonesian National Standard (Standar Nasional Indonesia ? ?SNI?) framework by extending the eligible Standard Classification of Indonesian Business Fields (Klasifikasi Baku Lapangan Usaha Indonesia ? ?KBLI?) scope for re-packers to include KBLI Codes 82920 and/or 82922. This Amendment also removes the mandatory sifting facility and longer allows new companies to utilize Quality Management System (?QMS?) statement letter in place of an International Organization for Standardization (ISO) 9001:2015 QMS certificate.

This Regulation establishes requirements for affixing non-halal remarks to products using specified non-halal materials or production processes. Remarks must be proportionate, clearly visible, readable and durable. This Regulation also sets visual standards for food and beverage and non-food and beverage products, with products already in circulation granted a 12-month grace period until 23 July 2027 to comply.

This Regulation establishes various eligibility and competency requirements that will now apply to clinical educators, including valid STR and SIP and at least two years of active professional practice. The new Regulation also provides a number of entitlements and an academic career pathway up to the professor level for clinical educators, while requiring healthcare service facilities to maintain data-based records that are integrated into SIKN and the Ministry of Higher Education, Science and Technology?s information system.

BPOM has put together a standardized electronic procedure for the issuance of drug export documents, including Certificates of Pharmaceutical Products and Good Manufacturing Practice Compliance Certificates. The Draft Regulation is set to introduce mandatory single-account registrations, electronic verifications, strict evaluation timelines that are governed by clock-on/clock-off mechanisms and formal third-party export contracting rules. Any non-compliance or submission of false data risks immediate electronic system suspensions that may last for up to one year.