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.

BPOM has introduced a more robust framework for the withdrawal and destruction of non-compliant drugs and drug materials by expanding recall obligations to cover products with non-compliant product information and imposing additional certification requirements upon biological products. The new Regulation also strengthens recall triggers, broadens the entities subject to recalls, including retail outlets, and provides transitional arrangements for recalls that were initiated under the previous regime.

If it is ultimately enforced, then this Draft Regulation will introduce two classifications of pharmaceutical precursors and will see reference standards encompassing new Analysis of Supervision Results (Analisa Hasil Pengawasan ? ?AHP?) requirements. The Draft Regulation is also set to streamline various administrative requirements, including exemptions from certain specific documentation requirements for qualifying Category 2 pharmaceutical precursors and certain exports. The new framework also introduces a power of attorney requirement for certain exporters. Meanwhile, the deadline for the submission of additional data has been extended to seven business days per permitted attempt.

This framework introduces a number of new requirements for halal slaughterhouses (Rumah Potong Hewan ? ?RPH?), mandating specific timeframes for stunning, slaughtering and hot-water dipping. The Decree goes on to set out a number of tiered certification requirements for compliance personnel based on their business sizes and also allows for automated machine slaughtering, compelling RPH operators to significantly overhaul their processing lines and logistics in order to maintain market access.