Indonesia has just overhauled the rulebook for its healthcare sector.
Minister of Health Regulation No. 5 of 2026 on Health Supplies (Permenkes 5/2026) consolidates and partly or wholly revokes 36 earlier regulations, making it one of the biggest regulatory shake-ups the industry has seen in years. It was issued to carry out Law No. 17 of 2023 on Health and its implementing regulation, Government Regulation No. 28 of 2024. Permenkes 5/2026 took effect on 4 May 2026. It's already binding, but several provisions give businesses up to a year to bring their operations in line with the new requirements. Rather than simply tweaking licensing procedures, the regulation rebuilds the entire healthcare supply chain from national demand planning and manufacturing standards to procurement, strategic reserves, and emergency preparedness.
This article covers four areas:
One of the significant changes introduced by Permenkes 5/2026 is the expansion of national medicines and medical devices planning requirements. Previously, planning mechanisms were primarily associated with medicines procured under government health programs such as the National Health Insurance (JKN/BPJS). Under the new regulation, planning now applies much more broadly to all health supplies, which are regulated under the integrated National Health Information System.
Planning information from central government, regional government, pharmaceutical management facilities, and healthcare facilities must be submitted through the integrated National Health Information System, enabling the Ministry of Health to generate a unified national supply plan. For pharmaceutical companies, distributors, and healthcare providers, this means greater transparency and increased reporting obligations to support the system.
The Government, regional governments, and healthcare institutions are required to prepare products demand by considering multiple factors, including:
Older regulations focused mainly on annual procurement planning. Permenkes 5/2026 goes further, requiring five-year plans, annual implementation plans, and periodic reviews that account for scientific and technological developments an approach designed to build long-term supply resilience without sacrificing flexibility.
Permenkes 5/2026 also introduces mandatory reserve stock requirements to strengthen supply resilience. Manufacturers, distributors, pharmaceutical warehouses, and healthcare institutions must now hold reserve inventory equal to 10–30% of projected demand arguably the regulation's most immediate operational change.
Reserve stock rules used to live in separate, sector-specific policies. Now, maintaining a minimum reserve is a core part of national healthcare supply planning, built in as an early-warning mechanism to help prevent sudden shortages. If a business expects a supply disruption or shortage, it must report this to the Government up to six months in advance, giving authorities time to step in before the situation escalates. The goal: fewer surprise medicine shortages and faster government intervention when problems do arise.
Based on the experience through the COVID 19 pandemic, one of the most important aspects is the coordinated healthcare logistics.
Permenkes 5/2026 therefore contains dedicated provisions governing healthcare supply planning during:
In these situations, the Government can run rapid health assessments, identify domestic and international supply sources, and coordinate procurement across ministries and agencies.
The regulation also allows emergency procurement measures, including importing generic medicines when domestic production can't meet urgent demand. New healthcare products already available globally may also get faster, more responsive regulatory pathways, helping patients access treatment sooner during emergencies, without abandoning oversight.
Permenkes 5/2026 also modernizes Indonesia's healthcare products manufacturing framework by unifying manufacturing standards into a single concept known as Good Manufacturing Practices (Cara Pembuatan yang Baik/CPB). Previously, different categories of healthcare products including pharmaceuticals, medical devices, cosmetics, traditional medicines, and household health products were regulated by separate manufacturing standards issued under different regulations. The new regulation harmonizes these standards under a unified framework whilst maintaining technical requirements issued by the relevant authorities for specific product categories.
Under the new regulation, all healthcare manufacturing facilities must:
The aim is greater regulatory consistency without compromising product safety, efficacy, or quality. One important point for manufacturers: existing production certifications aren't automatically wiped out by Permenkes 5/2026. If your certificate was validly issued under the old rules, you don't need to restart the certification process it stays valid until it expires, letting businesses transition smoothly and avoid unnecessary disruption or added compliance costs.
Contract manufacturing is common in Indonesia's pharmaceutical industry, many businesses outsource production to third-party facilities while keeping the distribution permit for the finished product. Permenkes 5/2026 changes who's on the hook when something goes wrong.
The regulation still allows production under license or contract, as long as the manufacturing facility meets CPB standards and holds the required certification. But now, everyone involved in the manufacturing contract shares responsibility for the safety, efficacy, and quality of the finished product. That's a real departure from the old approach, where the company commissioning the manufacturing generally carried primary responsibility on its own.
Because responsibility is now shared, both the product owner and the manufacturer need to revisit their agreements particularly the sections covering:
Any business that relies heavily on third-party manufacturers should check that its contracts actually reflect this new shared-responsibility model.
Permenkes 5/2026 formally recognizes micro and small businesses (UMK) as players in Indonesia's healthcare manufacturing industry. Going forward, qualifying micro and small businesses can produce certain categories of medical devices and household health products, provided they meet the required standards, but only for products that carry relatively low regulatory risk.
Eligible products generally:
This policy aims to encourage greater local businesses participation in the healthcare manufacturing sector while ensuring that higher risk products remain subject to more stricter regulatory controls.
Also read: Preparing for Indonesia Company Incorporation: What You Need to Know
Beyond manufacturing, Permenkes 5/2026 also reshapes how medicines and medical devices are procured and supplied across Indonesia. The biggest change here is the expanded role of Indonesia's Electronic Catalogue (E-Catalogue). Government institutions, regional governments, and healthcare facilities participating in public healthcare programs must generally procure supplies through the official E-Catalogue, a move meant to boost transparency, efficiency, and accountability while cutting down on manual purchasing.
Alternative procurement methods are only available when using the E-Catalogue isn't feasible under existing procurement rules. For suppliers, that makes E-Catalogue participation increasingly essential for winning government contracts.
Permenkes 5/2026 reinforces Indonesia's long-standing push to strengthen domestic healthcare manufacturing. Government purchasers must prioritize products made with domestic materials and locally manufactured components, favoring those with the highest local content (TKDN) or locally issued marketing authorizations. Notably, the regulation explicitly allows domestic products to be purchased even when they cost more than imported alternatives.
This also sets up a clearer path toward import substitution: where domestic production capacity is sufficient, imported products listed in the E-Catalogue may gradually be phased out in favor of local alternatives. Before making that call, the Ministry of Health will weigh domestic manufacturers' production capacity and their ability to meet national demand.
Importers should keep a close eye on government procurement policy, since further shifts toward domestically manufactured products may follow.
Public health emergencies and medical innovation don't always wait for standard approval timelines. Recognizing this, Permenkes 5/2026 introduces the Special Access Scheme (SAS), a faster route for medicines and medical devices that haven't yet obtained a distribution permit in Indonesia.
Under certain conditions, the Government can allow the use or procurement of products that aren't yet commercially registered in the country, including for:
SAS reflects Indonesia's attempt to balance regulatory oversight with quick access to essential healthcare products when standard approval timelines simply aren't practical. For pharmaceutical companies, this opens the door to bringing breakthrough products into Indonesia faster, especially those already approved or in use elsewhere.
There's also a significant compliance change on the import side. Starting 3 August 2026, importers of certain regulated pharmaceutical ingredients, including narcotics, psychotropic substances, and pharmaceutical precursors, must obtain import approvals from the Ministry under this new framework.
Businesses that import these ingredients should review their current licenses now and secure any new approvals before the deadline. Early preparation will be key to keeping supply chains running without interruption.
Permenkes 5/2026 creates new obligations for manufacturers, distributors, importers, healthcare facilities, and other players across Indonesia's healthcare supply chain. During the transition period, consider:
Businesses that get ahead of these requirements during the transition period will be far better placed to adapt — and to avoid unnecessary operational risk.
Permenkes 5/2026 is one of the broadest reforms to Indonesia's healthcare supply framework since the Health Law was enacted. Beyond folding dozens of older ministerial regulations into one, it introduces a more integrated approach to supply planning, strengthens domestic manufacturing, sharpens emergency preparedness, pushes digital reporting, and encourages wider use of locally made medicines and medical devices.
Pharmaceutical manufacturers, medical device companies, distributors, importers, and healthcare providers should use the transition period wisely reviewing internal compliance procedures, contracts, procurement strategies, and import licensing to make sure they're ready under the new framework. This article focused on planning, production, and supply. In our next piece, we'll dig into the remaining changes under Permenkes 5/2026 pharmaceutical pricing, halal requirements, product labelling, and the administrative sanctions for non-compliance.
Need Help Navigating Permenkes 5/2026?
Adjusting to this new regulatory framework can be complex, especially when it comes to reviewing compliance procedures, contracts, procurement strategies, and licensing requirements. CPT Corporate is ready to help your business stay compliant and competitive under the new rules.
We provide legal consulting, regulatory compliance support, licensing assistance, corporate secretary services, and other legal solutions tailored to Indonesia's healthcare and pharmaceutical sector. Contact CPT Corporate today to make sure your business is fully prepared for these changes.
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