The new framework has now expanded the types of halal certification ("Certification") services that are available through the SIHALAL platform by adding two new options (i.e. self-declared certification with independent funding and self-declared certification for product development or expansion). In addition, this Decree also introduces various criteria and requirements that must be met by micro- and small-scale enterprises ("MSE") in order for them to qualify for Certification.

The Draft Regulation provides a clearer definition of the Newly Developed Drugs (Obat Pengembangan Baru "OPB") concept and outlines five main stages: 1) Drug discovery and development, which involves the identification and development of potential therapeutic compounds; 2) Non-clinical trials, including pharmacology, toxicology studies and good laboratory practices; 3) Four-phase clinical trials to evaluate safety and efficacy; 4) Drug registration processes; and 5) Post-market monitoring, which encompasses vigilance, market surveillance, regulatory inspections and licensing establishment.

Natural medicine industries ("Industries") that meet certain criteria will be subject to the mandatory application of the Risk-Management Program (Program Manajemen Resiko "PMR") at their facilities. In this regard, said Industries must prepare and submit a total of eight sets of quality data documents to the BPOM. Said documents should include data on the following areas: 1) Implementation of quality control culture; 2) Self-inspections and/or internal audits; 3) Batch and recurring deviation rates; 4) Effectiveness of change controls; and so forth.

As several revisions to the applicable requirements for notifications used as distribution licenses from the Head of the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan "BPOM") prior to the commencement of promotional activities ("Notification") have been introduced, any business that has already received a cosmetics Notification number must update it to meet the new requirements by a deadline of 15 November 2025.

The Second Amendment updates a total of nine standards that specifically relate to business activities and products within the healthcare sector, as originally outlined under Regulation 14/2021, including: 1) Pharmacies; 2) Cosmetics wholesalers (Pedagang Besar Kosmetik/PBK); 3) Clinics; 4) Hygiene and sanitation; and 5) Dialysis services. Businesses with existing business permits have been granted a transitional period that runs until 14 November 2025 in order to bring their operations into line with the new provisions outlined under the Second Amendment.

The Foster Parent Program ("Program") defines specific eligibility requirements for companies acting as foster parents ("Foster Parents") and micro-, small- and medium-scale enterprises (Usaha Mikro Kecil Menengah "UMKM") acting as foster children ("Foster Children") in order to ensure that both parties are well-prepared to participate effectively. Foster Parents must have Corporate Social Responsibility programs in place that are aligned with the goals of the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan "BPOM"), while Foster Children must commit to good manufacturing practices for natural medicines and cosmetics products, and must also adhere to sustainable production systems. Both parties are expected to sign commitment letters and fulfill roles such as training, resource sharing and compliance with regulatory standards, forming mutual partnerships to enhance product safety and quality.

Hospitals are now being guided to focus more on the provision of priority clinical services in line with specific, measurable indicators that are tailored to both general and specialized hospitals. Moreover, the Decree also simplifies and consolidates patient and facility safety standards, requiring hospitals to ensure secure environments, conduct regular risk assessments and maintain safe facilities. For example, the number of safety management aspects has now been reduced, thereby streamlining implementation.

While the gradual implementation of halal certification, as applicable to food and beverage products and ingredients that are manufactured by medium- and large-scale enterprises, has now reached the end of the line and said mandatory certification is therefore now in full force, the same gradual implementation for micro- and small-scale enterprises has now been extended until 17 October 2026. On of the key features that have been introduced under Regulation 42/2024 include lifetime permanent validity for halal certificates issued by the Halal Product Guarantee Agency (Badan Penyelenggara Jaminan Produk Halal "BPJPH"), provided that no changes are made to the relevant composition of ingredients and/or halal product processing (Proses Produk Halal "PPH").

Halal certificates will have indefinite validity, eliminating the need for regular renewals, provided that no modifications are made to the relevant materials or production processes. Should any changes arise, then an application for an updated certificate must be submitted electronically along with the required documentation. For foreign products, certification can be applied for via an importer or authorized representative based in Indonesia, especially in cases where a halal certification body is not available in the country of origin. Additionally, the renewal timeline for foreign halal certificates is also set to be adjusted, requiring submissions to be completed at least 60 days prior to the relevant expiration dates.

The Draft Regulation specifies that nutritional value information (Informasi Nilai Gizi "ING") labels must be affixed to the fronts of the packaging of relevant processed food products ("Products"). Labels should feature the following information and markings: 1) Nutri-Level (i.e. label that indicates the total sugar, salt and fat [Garam, Gula dan Lemak "GGL"] content of a Product); and 2) Healthier Choice Logo (i.e. logo that may be affixed to any Products that meet the nutrition profile criteria stipulated for each Product type). The above-mentioned Nutri-Levels comprise four levels that relate to the total GGL content of Products (ranging from level A to level D).