SwissCham Indonesia’s Participation in the Indonesia-Europe Business Forum

Key Takeaways:

Indonesia’s medtech market is sizeable and growing. ASPAKI highlighted a market of about USD 1.9 billion, with 843 manufacturers and domestic utilization rising from around 12% in 2021 to 48%. This supports opportunities in high-tech devices, diagnostics, digital health, AI, SaMD, components, and joint manufacturing.
Halal requirements need to be built into medtech market-entry planning. Risk Level A medical devices face the earliest certification deadline on 17 October 2026, followed by Risk Levels B in 2029, C in 2034, and D in 2039. Foreign certificates may be recognized where a mutual-recognition arrangement with BPJPH exists.
Swiss pharmaceutical companies have a specific regulatory advantage. Switzerland is among BPOM’s 7 reference jurisdictions, and eligible products may use the 90-working-day reliance pathway. BPOM also presented 50-, 100-, and 300-working-day pathways for other categories.
Patient access remains broader than registration. The Ministry highlighted that access depends on HTA, Fornas, pricing, e-Catalogue, procurement, financing, JKN coverage, diagnostics, and clinical readiness. A National Strategy for Innovative Medicines is being developed around 4 key areas: regulation, investment/financing, HTA, and pricing/procurement.
Indonesia is actively strengthening its clinical-trial ecosystem. Trial initiation was presented as improving from about 9–12 months to 3–8 months. A 2025 mapping covered 98 clinical research sites, including 23 advanced, 51 intermediate, and 24 basic sites.
Genomics and precision medicine are emerging as major collaboration areas. The revised deck reported 31,076 participants recruited, 21,166 whole genomes sequenced, more than 2 PB of genomic data, and sequencing capacity of around 12,500 genomes per year. The planned Indonesia GeneBank targets 11 million tubes, around 1.1 million participants, and 10 PB of data, with full operation targeted for 2028
Pharmaceutical raw materials remain a major investment gap. The session noted that around 90% of APIs are imported. The Ministry of Health referred to 42 locally produced APIs, while the Ministry of Industry referred to 45 locally produced pharmaceutical raw materials/APIs; this difference should be confirmed before external use.
Investment conditions are attractive, but regulatory predictability remains critical. The discussions highlighted incentives such as up to 300% R&D super tax deduction, up to 200% vocational-training deduction, tax allowances, SEZ benefits, and import-duty relief. At the same time, TKDN, procurement design, and regulatory complexity remain important factors in how Indonesia competes with other ASEAN markets for investment.

Halal Certification, Joint Assembly and Joint Investment in Medical Devices

Session I connected three closely related themes for companies active in the healthcare and medical-device sector: halal-certification requirements, the growth of Indonesia’s medical-device industry, and practical models for local assembly, manufacturing, technology transfer and investment.

The overall message was that companies entering or expanding in Indonesia need to look at regulatory compliance and market strategy together. Halal requirements can affect market readiness and product planning, while localization and partnership models can create longer-term opportunities for manufacturing, innovation and access to the wider ASEAN market.

Halal certification is part of Indonesia’s product-regulatory framework

BPJPH presented the legal framework for Halal Product Assurance, including Law No. 33/2014 and Government Regulation No. 42/2024.

Not every product follows the same treatment: products can fall under halal-mandatory, exempt, or non-halal-notification categories depending on the product and materials.

The timeline matters directly for medical devices

Medical equipment Risk Level A is included in the certification stage ending 17 October 2026.

Medical equipment Risk Level B is scheduled up to 17 October 2029, Risk Level C up to 17 October 2034, and Risk Level D up to 17 October 2039.

This phased schedule means companies should identify the risk class of their products early and build halal requirements into market-entry and localization planning.

Regular certification process for larger and foreign businesses

The regular scheme involves BPJPH, a Halal Inspection Agency (LPH), and a halal determination process by MUI or the Halal Product Fatwa Committee.

BPJPH presented an indicative end-to-end process of around 28-42 working days, depending on the case, and applications are handled through the SIHALAL electronic system.

Companies applying for halal certification need supporting documents, product and ingredient information, process information, and a Halal Supervisor. For medium, large and foreign enterprises, the presentation states that the Halal Supervisor must hold training and competency certificates.

Foreign halal certificates can be recognized

Where a foreign halal institution has mutual recognition with BPJPH, the foreign halal certificate does not need a new Indonesian halal-certification application, but it must be registered before the product is distributed in Indonesia.

The presentation states that the foreign halal certificate registration process takes around 13 working days and is handled through SIHALAL.

This mutual-recognition route is particularly relevant for Swiss exporters because it may reduce duplication where an eligible recognized foreign halal certification body is available.

Indonesia already has a large medical-device ecosystem

Around 740 local manufacturers, 7,123 local distributors, 85 clinical research centers, and 27 testing laboratories were highlighted in the presentation.

Domestic medical-device registrations have grown strongly, supported in part by government policies that prioritize locally manufactured products.

GAKESLAB has more than 1,500 members across Indonesia, including manufacturers, distributors, healthcare consultants, IT companies, calibration providers, and maintenance companies.

Regulation and localization matter

Companies entering Indonesia need to consider TKDN/local-content requirements, product registration, distribution permits, Good Distribution Practice, Good Manufacturing Practice, and halal requirements where applicable.

GAKESLAB highlighted close coordination with the Ministries of Health, Industry, Investment and other public institutions.

Several entry models are possible

Foreign direct investment, joint ventures, contract manufacturing, subcontracting/OEM arrangements, and technology transfer were presented as practical options.

International companies can contribute technology, design, expertise and brands, while Indonesian partners contribute manufacturing capacity, local market knowledge and access to the domestic ecosystem.

Main barriers and GAKESLAB’s role

Key barriers include high R&D and clinical-validation costs, differing regulatory requirements, certification and licensing requirements, lack of trusted partners, and shortages of specialized skills.

GAKESLAB can support business matching, regulatory information and training, government connections, and understanding of the local medical-device business environment.

From market access to co-creation

ASPAKI’s central message was that European companies should consider Indonesia not only as a place to sell products, but as a place to build, innovate and grow together. The presentation highlighted a medical-device market of about USD 1.9 billion, 843 manufacturers, and a rise in domestic utilization from around 12% in 2021 to 48%.

Localization is a journey

IMPORT -> ASSEMBLY -> MANUFACTURING -> TECHNOLOGY TRANSFER -> INNOVATION -> GLOBAL

Four capability gaps create partnership opportunities

Technology gap: limited domestic capability for high-tech devices.

R&D gap: limited large-scale clinical and industrial research.

Supply-chain gap: dependence on specialized imported components and fragmented local suppliers.

Commercial-scale gap: need for clearer long-term demand signals and stronger integration with global OEM networks.

Four priority collaboration areas

High-tech medical devices: patient monitoring, advanced imaging, ventilators and anesthesia, surgical/electromedical equipment, and in-vitro diagnostics.

Digital health: AI-assisted diagnostics, remote patient monitoring, connected devices, Software as a Medical Device (SaMD), and telemedicine.

Components: medical-grade sensors, electronic modules, precision components, biomaterials, and sub-assemblies.

R&D and clinical cooperation: joint product development, regional clinical trials, university-industry laboratories, and standards harmonization.

Possible business models

Contract manufacturing, joint assembly, technology transfer and licensing, joint ventures, joint R&D, and an ASEAN export-hub model.

ASPAKI stressed that companies do not need to build a factory from day one. Joint assembly can be a practical first step, with deeper industrialization as the relationship and market develop.

Important Points:

Medical-device priorities are increasingly linked to real procurement demand and gaps between domestic supply and market needs.

Areas discussed included imaging, ventilators, diagnostics, and devices supporting preventive and primary healthcare.

Disease areas mentioned as important include cancer, cardiovascular disease, stroke, and urology/nephrology.

Existing foreign collaboration is diverse, with examples from Asian, European and US companies.

The long-term ambition is broader than TKDN compliance: Indonesia wants co-creation, innovation, regional exports, and stronger integration into global supply chains.

What Is Most Important for SwissCham Indonesia Members

Halal readiness should be part of market-entry planning

Swiss healthcare and medtech companies should check early whether their products fall within a halal-mandatory category and which certification timeline applies. For Risk Level A medical devices, the 17 October 2026 deadline is particularly relevant.

Foreign certificate recognition may simplify compliance

For Swiss exporters, it is important to determine whether the relevant foreign halal certification body is recognized by BPJPH. Where mutual recognition exists, registration of the foreign certificate may replace a new Indonesian certification process.

Strong opportunity for Swiss medtech and technology companies

Swiss strengths in diagnostics, laboratory technology, precision engineering, sensors, components, digital health, AI, medical software, patient monitoring and clinical research fit well with the capability gaps identified in the session.

Entry can be gradual

For Swiss SMEs in particular, market entry does not require a large investment at the beginning. Companies can start with distribution, business matching or assembly and deepen cooperation as demand and confidence grow.

Local partner selection is critical

ASPAKI and GAKESLAB can serve as bridges to local manufacturers, distributors, regulators and business partners. SwissCham can add value by connecting Swiss technology providers with credible Indonesian partners.

TKDN and halal should be assessed together

For companies considering local assembly or government procurement, the TKDN pathway and halal-certification requirements should be mapped early because both can influence product configuration, materials, partner selection and timing.

Indonesia can be considered as an ASEAN base

The opportunity is not limited to Indonesia. The session positioned Indonesia as a possible regional manufacturing and export base, creating a model of Swiss technology combined with Indonesian manufacturing and scale.

R&D and university partnerships are relevant

Joint research, clinical trials, university-industry cooperation and product development are relevant for Swiss medtech companies as well as Swiss universities, research organizations and innovation partners.

It showed that successful medical-device market entry in Indonesia increasingly requires an integrated approach: regulatory readiness (including halal where applicable), a clear localization strategy, and the right local partners. For Swiss companies, the opportunity is not only to sell into Indonesia but also to assemble, manufacture, transfer technology, conduct R&D and scale solutions with Indonesian partners for Indonesia and ASEAN.

Availability and Accessibility of Innovative Medicines in Indonesia

It focused on how Indonesia can make innovative medicines more available, accessible, and affordable for patients. The discussion covered two connected parts: BPOM’s role in accelerating regulatory approval and supporting clinical development, and the Ministry of Health’s role in strengthening the post-registration pathway through HTA, the National Formulary, pricing, procurement, JKN coverage, and a broader National Strategy for Innovative Medicines.

For SwissCham members, the session was particularly relevant because Switzerland is already recognized by BPOM as one of the reference jurisdictions under the reliance mechanism, while Swiss pharmaceutical and healthcare companies are active in innovative medicines, diagnostics, clinical research, and health-system partnerships.

BPOM is positioning regulation as an enabler of innovation:

BPOM described its approach as science-based and risk-based regulation across the full product life cycle, from R&D and clinical trials through registration, post-market surveillance, and enforcement.
Since December 2025, BPOM has held WHO-Listed Authority status for vaccines, which it linked to stronger international trust, higher quality standards, exports, investment, and international cooperation.

Several registration pathways can accelerate innovative medicines

50 working days: new drug development by pharmaceutical industries investing in Indonesia.

90 working days: reliance route for products supported by reference-country assessments; Switzerland is among the seven reference jurisdictions identified by BPOM, alongside the EU/European reference pathway, USA, Australia, Canada, UK and Japan.

100 working days: selected life-saving drugs, orphan drugs, medicines for national health programmes, certain products with at least one clinical trial in Indonesia, and first registrations by pharmaceutical companies investing in Indonesia.
300 working days: the regular route for new drugs and biological products that do not qualify for the accelerated pathways.

Reliance can be a concrete opportunity for foreign companies

BPOM reported 203 accelerated approvals through reliance since 2019.

Key reliance requirements include a complete unredacted assessment report, approval in the reference country within the previous five years, and product sameness with the reference-country product.

BPOM retains the final sovereign decision and may require a full local assessment where disease patterns, resistance, or national-program considerations make reliance inappropriate.

BPOM is also supporting innovation before and after registration

Regulatory assistance can be provided during new-drug development, clinical trials, and registration.

Emergency Use Authorization can be processed in 20 working days, supported by rolling submissions and adaptive clinical-trial approaches where relevant.

BPOM also highlighted faster GMP certification, site approval, and technology-transfer review for new production facilities.

Indonesia wants to become a stronger clinical-trial destination

The BPOM presentation cited around 1,609 clinical trials since 2019 and 159 clinical-trial sites in Indonesia.

BPOM linked stronger clinical-trial capacity to faster patient access, a stronger research ecosystem, and increased investment.

The ecosystem described includes industry, academia, clinicians, patients, investors, government, and regulatory authorities, with needs ranging from early-stage facilities and skilled personnel to critical equipment, data capability, and R&D financing.

Special Economic Zones can offer an additional access route

BPOM highlighted the Special Access Scheme (SAS) for health-sector Special Economic Zones, including Sanur, for certain medicines meeting safety, efficacy, and quality criteria.

The presentation indicated an evaluation time of 4 working days for SAS use in health services in the SEZ and 10 working days when used for clinical trials.

Registration is only one gate; patient access depends on the post-registration ecosystem

The Ministry’s presentation emphasized that even after a medicine is registered, several steps still determine whether patients can actually access it. These include distribution, clinical-guideline updates, diagnostic readiness, HTA, National Formulary selection, pricing, e-Catalogue listing, procurement, insurance coverage, and availability of financing.
Public-sector access generally moves from HTA to National Formulary selection, followed by price negotiation, procurement, and JKN/programme coverage.
Private-sector access may begin earlier through private insurance or out-of-pocket purchase, and data generated there can later support HTA and policy decisions.
Clinical guidelines, diagnostic modalities, physician capability, post-marketing data, utilisation data, and claims data are also important enablers.

A National Strategy for Innovative Medicines is being developed

The Ministry is developing a National Strategy to improve the availability, accessibility, and affordability of innovative medicines.
Four priority areas were identified: regulatory framework; investment and health financing; Health Technology Assessment (HTA); and pricing and procurement control.
The Ministry proposed collaboration among government, the pharmaceutical industry, and other stakeholders through a working group to develop and implement the strategy.

The Ministry supports accelerated registration for priority medicines

The Ministry can provide recommendations supporting expedited registration for life-saving drugs, medicines addressing unmet medical needs, orphan drugs, and medicines for national health programmes.
These recommendations are intended to support faster access through BPOM’s regulatory process.

HTA is intended to connect evidence with JKN access

The Ministry presented HTA as one gate and one standard for assessing innovative medicines for adoption into JKN.
Assessment covers clinical effectiveness, safety, cost-effectiveness, budget impact, and wider acceptance considerations, followed by HTA Committee appraisal and a Ministry decision.
The process includes Stakeholder-Led Submission, allowing industry, medical-device manufacturers, and patient associations to submit HTA dossiers for appraisal.
The intended downstream pathway is HTA recommendation → Ministry decision → National Formulary → e-Catalogue access → monitoring and evaluation.
Value-based pricing was highlighted as part of the new approach.

A pricing confidentiality mechanism is already emerging for innovative medicines

The Ministry presented an “Innovative Medicines Collection” in e-Catalogue where the best/reference price is not displayed publicly before login.
Pharmaceutical companies may apply through the Directorate of Pharmaceutical Production and Distribution, accompanied by a statement that the e-Purchasing price will not exceed the applicable claimed value.
This is particularly relevant for multinational companies that need to manage global price-reference risks while still participating in Indonesian public procurement.

Access requires broad stakeholder collaboration

Government: align and accelerate policy, integrate HTA recommendations into Fornas/JKN, and explore innovative financing.
Industry: maintain supply continuity, support local manufacturing and technology transfer, and contribute evidence.
Academia: generate research, epidemiological data, real-world evidence, and budget-impact analysis.
Professional organizations: provide clinical input to HTA, support monitoring, and educate patients on innovative therapies.

What Is Most Important for SwissCham Indonesia Members

Switzerland is already a BPOM reference jurisdiction. This creates a practical regulatory advantage for Swiss pharmaceutical companies. Companies should assess early whether a product can qualify for the 90-working-day reliance pathway and whether the necessary unredacted assessment documentation from the reference authority can be made available.
Regulatory approval is not the end of the access strategy. Members need to plan registration, HTA, Fornas, pricing, e-Catalogue, diagnostics, clinical guidelines, procurement, and financing as one connected market-access pathway.
The new National Strategy creates an advocacy and partnership window. SwissCham can engage the Ministry while the framework is still being developed, especially on regulatory predictability, HTA implementation, financing, pricing confidentiality, procurement, and data requirements.
The e-Catalogue confidentiality mechanism is highly relevant. This directly addresses a concern often raised by multinational pharmaceutical companies: public disclosure of Indonesia-specific negotiated prices can affect global reference pricing. SwissCham should clarify the eligibility criteria and practical application process for the Innovative Medicines Collection.
Clinical trials are an investment opportunity. Indonesia is actively trying to build clinical-trial capacity. Swiss companies involved in innovative medicines, diagnostics, CRO services, laboratory technology, data systems, and research infrastructure may find partnership opportunities with hospitals, universities, and local research institutions.
Local investment can create regulatory advantages. BPOM’s accelerated pathways explicitly recognize certain medicines developed or first registered by pharmaceutical companies investing in Indonesia. This means investment strategy and regulatory strategy can be linked.
HTA and real-world evidence will become increasingly important. SwissCham members should consider how they can contribute local clinical evidence, epidemiological data, utilisation data, disease registries, and budget-impact evidence to support access decisions.

Clinical Trials and Joint Research

It focused on how Indonesia can become a stronger destination for clinical trials and joint research, and how European companies, research institutions, universities and technology partners can work with the Indonesian health and research ecosystem.

Across the three presentations, a common message emerged: Indonesia has substantial population scale, disease diversity, hospitals, research assets, scientific capability and growing government support, but the country still needs faster procedures, stronger site capacity, clearer coordination, more global trial sponsors and deeper international research partnerships.

The opportunity is broader than sponsoring a clinical trial. Swiss companies can participate in clinical research, genomics, diagnostics, data and AI research, vaccine and biologics development, technology transfer, use of national research infrastructure, and long-term public-private research partnerships.

Indonesia has scale, but sponsored clinical trials remain underdeveloped

The Ministry highlighted Indonesia’s population of about 287 million, more than 3,300 hospitals, over 10,000 primary health centers and more than 24,000 clinics as a significant base for health research.
Indonesia has a high volume of locally initiated research, but comparatively few internationally sponsored trials. This was presented as an untapped opportunity rather than a lack of demand.
The Ministry wants Indonesia to move from being a secondary or fallback trial location toward being considered earlier in global clinical-development planning.

Main bottlenecks are known and are being addressed

Key issues identified include administrative complexity, inconsistent Material Transfer Agreement (MTA) timelines, multi-center ethics approvals, uneven clinical-trial infrastructure, limited investigator and human-resource capacity, and low public awareness of clinical-trial safety.
Institutional responses include the Indonesia Clinical Research Center (INA-CRC), upgraded MTA services, digitalized and more transparent procedures, the Indonesia Clinical Research Registry (INA-CRR), and work toward a national ethics mechanism for multi-center research.
The MTA reform launched in 2024 was presented as a significant improvement. The revised deck shows an 88.4% approval rate, weekly MTA Committee reviews, and indicative processing windows of 6-11 working days for exempted applications, 9-24 working days for expedited applications and 16-26 working days for full-board applications. Clinical trials accounted for 63% of approved full-board submissions.

INA-CRC is intended to function as a practical one-stop facilitator

INA-CRC can support pre-feasibility studies and connect sponsors with hospitals and Clinical Research Units (CRUs).
The Ministry mapped the end-to-end pathway covering ethics, research registration, BPOM or MoH submissions, site approvals, MTA, import permits and customs processes.
The presentation emphasized that INA-CRC can coordinate between CRUs and the relevant government stakeholders rather than leaving sponsors to navigate each institution separately.
The revised presentation gives a more concrete startup benchmark: reforms and digitalization are reported to have reduced clinical-trial initiation from roughly 9-12 months to 3-8 months. Clinical Trial Approval, ethics review, CTA negotiation and MTA can be advanced in parallel, followed by import-permit processing.

Clinical research capacity is expanding

A 2025 mapping exercise covered 98 clinical research sites: 23 were classified as advanced, 51 as intermediate and 24 as basic.
The Ministry highlighted a ready network of advanced sites in Java, with additional regional anchors outside Java that can provide geographic and sociodemographic diversity.
The number of clinical studies presented in the Ministry deck increased from 73 in 2019 to 729 in 2026, with INA-CRC established in late 2024 as part of the strengthened ecosystem.
The updated deck also shows that Indonesia is already handling externally sponsored studies at scale: 2026 contracted trials were reported at more than IDR 16.5 billion in disclosed value across 14 sponsors/funders, alongside AI-validation partnerships in radiology, digital pathology, ultrasound and pharmacogenomics.

Genomics is a major partnership area

The Biomedical and Genome Science Initiative (BGSI), launched in 2022, is building an Indonesian genomic reference so research and clinical decisions do not depend mainly on non-Indonesian population data. The revised deck reports 31,076 participants recruited, 21,166 whole genomes sequenced, more than 2 PB of genomic data generated and sequencing capacity of approximately 12,500 genomes per year.
Priority collaboration areas are framed around infectious diseases; oncology, cardiovascular and metabolic diseases; rare disease and precision medicine; the health-system and regulatory ecosystem; and AI in health. Examples include TB and dengue studies, pharmacogenomics-guided dosing, regional biomarker discovery, rare-disease diagnostic panels and registries, real-world evidence, decentralized-trial pilots and Indonesian-population validation of AI/SaMD models.
For genomics and data-intensive research, BB Binomika proposes controlled-access models in which partners can analyse de-identified data through a Trusted Research Environment (TRE) without taking ownership of, or exporting, raw genomic data.
Industry-partnership models presented for discussion include pharma-consortium co-funding with time-limited analytical access, sovereign public-private delivery, clinical-service integration, and commissioned research with controlled TRE access. The underlying principle is shared value while keeping raw data under Indonesian governance.
The Indonesia GeneBank is under construction as a national multi-omics infrastructure. The revised deck targets full operation in 2028, with an estimated capacity of 11 million tubes (about 1.1 million participants) and 10 PB of data.

BRIN is positioning itself as an open infrastructure partner

Health Sovereignty is one of Indonesia’s national research agendas under the 2026-2045 research roadmap.
BRIN’s infrastructure partnership directorate acts as an intermediary between partner needs and state-owned research assets, including laboratories, science and technology parks and specialist facilities.
For health, BRIN highlighted the National Genomic Lab, Cryo-EM facilities, high-containment infectious-disease laboratories and other life-science infrastructure.

Research priorities closely match Swiss capabilities

BRIN identified clinical trial collaboration, genomics and biologics research, diagnostic technology transfer, pharmaceutical raw materials, vaccines and biosimilars as areas for partnership.
The broader portfolio is aligned with APIs and strategic pharma raw materials, medium- to high-tech medical devices, health biotechnology, life sciences, digital health and diagnostics.

There are structured pathways for cooperation

BRIN described three main mechanisms: industry-facilitation partnerships, asset utilization, and managing-partner arrangements for eligible domestic partners.
For European partners, the practical route is to join BRIN business-matching activities, submit a letter of interest and proposal, undergo evaluation, agree the scope and financing/benefit-sharing terms, sign a cooperation agreement, and then jointly implement and monitor the project.
Foreign research cooperation may also require research permits, ethical clearance and MTA/clearinghouse processes depending on the project.

Intellectual property and benefit sharing need early attention

Joannes stressed that outcomes generated through BRIN infrastructure and Indonesian resources cannot automatically be treated as exclusively owned by a foreign partner.
For Swiss companies and universities, IP ownership, access rights, commercialization rights and benefit sharing therefore need to be negotiated early in the project design rather than after research has started.

Bio Farma presented practical lessons from accelerating vaccine trials

Bio Farma is a state-owned life-science group with more than 130 years of history, international vaccine distribution and experience across R&D, clinical trials, manufacturing and technology transfer.
The company highlighted its partnerships with global organizations and its use of a pentahelix model bringing together academia, business, government, community and media.

Acceleration depends on coordination, not only regulation

Bio Farma’s experience showed that clinical-development timelines can be shortened when regulators, sponsors, investigators, hospitals and CROs engage from the early planning stage.
Practical acceleration measures included parallel or seamless study designs, multicenter participation, dedicated investigators, weekly coordination and rapid responses to regulator or ethics-committee requests.
Digitalization, particularly electronic Case Report Forms (e-CRF), was highlighted as important for faster data entry, analysis, multicenter integration and remote monitoring.

BPOM support was an important enabler

Bio Farma highlighted clear regulatory guidance, early scientific discussion, rolling submissions and accelerated Clinical Trial Application review as important contributors to faster study start-up.
During accelerated vaccine development, fast-track CTA timelines were presented as being shortened from 20 working days to as little as 4 working days in the relevant mechanism.

Site selection and public trust remain critical

Bio Farma has worked with clinical-trial centers across several Indonesian cities and stressed the need for feasibility assessments covering capability, commitment, recruitment potential and local networks.
Persistent challenges include bureaucracy, uneven site and human-resource capability, data collection, subject recruitment, vaccine hesitancy and misinformation.
Community engagement and communication are especially important where public concerns include safety and halal aspects.

Important Points:

It emphasized that GCP training, sponsor feasibility assessment, careful PI selection, regular sponsor monitoring, BPOM inspections, and continuing updates to the national clinical-research registry can help ensure that principal investigators comply with study protocols.
The discussion reinforced that Indonesia is trying to improve trial visibility and accountability through the clinical-research registry, including encouraging researchers to keep study information current and close completed trials properly.
Speakers repeatedly invited companies to approach the relevant focal points early. The practical message was to discuss study plans before formal submission rather than waiting until a regulatory or operational problem appears.

What Is Most Important for SwissCham Indonesia Members

Indonesia is actively looking for more international clinical-trial sponsors

Swiss pharmaceutical, biotech, diagnostics and medtech companies can explore Indonesia earlier in global study planning, particularly where large patient populations and disease burden can support recruitment.

INA-CRC can reduce the navigation burden

For members unfamiliar with Indonesia’s clinical-trial process, INA-CRC can be a useful entry point to identify sites, understand submissions and coordinate with hospitals and authorities.

Genomics creates a major new collaboration opportunity

The BGSI program creates possibilities for precision medicine, biomarker discovery, pharmacogenomics, rare-disease research, AI validation and real-world evidence. This is especially relevant to Swiss pharma, biotech, diagnostics, universities and data/AI companies.

BRIN provides research infrastructure that companies do not need to build themselves

Swiss companies can potentially use Indonesian laboratories, research infrastructure and scientific capabilities through structured partnership and asset-utilization models, reducing the need for full greenfield research infrastructure at the beginning.

IP and data governance must be planned from day one

Swiss partners should clarify IP ownership, benefit sharing, MTA terms, genomic-data access, data protection and commercialization rights before entering joint research projects.

Clinical-trial partnerships can support a wider Indonesia strategy

Clinical trials and joint research can create local evidence, investigator relationships and disease-specific data that support a broader pathway from pilot evidence and cost-effectiveness work to HTA, clinical recommendations, hospital/national pathways and ultimately reimbursement or nationwide implementation.

Data-access partnerships can be structured without raw-data transfer

For Swiss pharma, biotech and research institutions concerned about data sovereignty, the TRE model offers a practical route to fund defined research questions and analyse Indonesian genomic data under controlled access while raw data remain in Indonesia.

There is room for Swiss expertise in capacity building

Training in GCP, clinical operations, biostatistics, data management, digital trials, genomics, AI validation and quality systems could be practical areas for Swiss institutions and companies to contribute.

Pharmaceutical and Raw Materials Industry: Joint Investment and Joint Assembly

Session IV focused on how Indonesia wants to strengthen its pharmaceutical and medical-device industries through local production, stronger upstream supply chains, technology transfer, joint investment, joint ventures, research and development, and closer cooperation with European partners.

The two speakers presented complementary perspectives. The Ministry of Health focused on health-sector resilience, local-product utilization, partnership opportunities, Special Economic Zones, and investment facilitation. The Ministry of Industry focused more deeply on the industrial base, dependence on imported pharmaceutical raw materials, TKDN/local-content rules, investment incentives, business licensing, natural-based medicines, and areas where European technology and investment could support Indonesia.

Indonesia is pushing health-industry resilience from upstream supply to downstream use

The Ministry linked local production with national health resilience and a more predictable domestic market for companies that invest and manufacture in Indonesia.
The presentation referenced locally produced APIs, WHO-prequalified Indonesian vaccine and pharmaceutical products, and a growing medical-device sector as evidence that domestic capabilities are improving.

European companies are invited to cooperate across R&D, manufacturing and market access

Cooperation areas mentioned included clinical trials, technology transfer, co-development, local production, investment, and joint ventures.
The Ministry also highlighted business matching as a practical way to connect international technology providers with Indonesian healthcare and manufacturing partners.

Special Economic Zones can be an investment entry point

For health-related Special Economic Zones, the presentation highlighted tax holidays/tax allowances, lower upfront and operational costs, R&D super tax deductions of up to 300%, and regulatory/facility support within the zones.
Health-related investment locations referenced in the discussion included Bali/Sanur, Batam, Banten and Sentul.
During the Q&A, participants were advised to contact the relevant Special Economic Zone office directly for detailed incentive and investment procedures, while the Ministry of Health can provide sector priorities and medical-device landscape information.

The Government sees Europe as a long-term partner, not only a supplier

Existing partnerships with companies from Denmark, Germany and Italy were mentioned as examples that cooperation is already taking place.
The Ministry emphasized sustained collaboration among government, industry and academia, and encouraged future business matching and joint-venture exploration.

Indonesia has a large pharmaceutical market, but production remains geographically concentrated

The presentation referenced 224 pharmaceutical-industry facilities, with most activity concentrated in western Indonesia. This affects availability, distribution and pricing in central and eastern regions, where supporting infrastructure is still developing.
Industry capacity utilization in 2025 was presented at around 72%, higher than the roughly 50-60% range mentioned for earlier years.
Domestic pharmaceutical producers were described as holding about 90% of the market by volume, but around 70% by value. Imports account for only about 10% of volume but around 30% of value, reflecting the importance of high-value innovative and biological products.

Raw materials are one of the clearest investment gaps

Despite strong domestic finished-product production, Indonesia remains heavily dependent on imported APIs and excipients. The speaker described that around 90% of APIs are imported.
This was presented as a strategic opportunity for European investment in API and excipient production, especially where technology, scale, quality systems and market certainty can be developed together.
The Ministry of Health speaker referred to 42 locally produced APIs, while the Ministry of Industry speaker referred to 45 locally produced pharmaceutical raw materials/APIs. These figures were presented differently during the session and should be confirmed before external use.

TKDN/local-content rules are highly relevant to investment structure

Two Ministry of Industry regulations were referenced for pharmaceutical local-content calculations: Regulation No. 35 of 2025 and Regulation No. 16 of 2020.
The discussion indicated that pharmaceutical companies may choose the calculation approach that better fits the characteristics of the product, while the practical result can differ significantly between in-house manufacturing and contract/co-manufacturing structures.
Direct materials carry substantial weight in the local-content calculation. This means local API and excipient availability can materially improve a product’s TKDN result.
The presentation also noted that the newer calculation approach may require more detailed disclosure of product formulation and raw-material values, which can be commercially sensitive for companies.

Natural-based medicines offer research opportunities, but foreign manufacturing investment is restricted

Indonesia has a large natural-resource and traditional-medicine base, with nearly 2,000 jamu products, 79 standardized herbal medicines and 22 phytopharmaceuticals referenced in the session.
The speaker emphasized opportunities for European cooperation in research, new active ingredients, innovative formulations, standardization, pre-clinical and clinical research, technology, quality and global market access.
During the discussion, restrictions on foreign investment in certain natural-based medicine manufacturing activities were mentioned. However, the presentation also identified natural-based medicines as an area for strategic collaboration and investment. The precise investment scope should therefore be clarified with the Ministry of Industry/BKPM before being communicated externally

A package of fiscal and non-fiscal investment incentives was highlighted

Tax allowance: a 30% reduction in net taxable income based on eligible tangible fixed-asset investment was referenced.
R&D super tax deduction: up to 300% gross-income reduction for qualifying R&D activities conducted in Indonesia.
Vocational-training super tax deduction: up to 200% gross-income reduction for qualifying training, apprenticeships and competency-based programs.
Import-duty exemptions may apply to machinery, goods and materials needed for industrial construction or development when equivalent domestic supply is unavailable or insufficient.

The licensing path involves several authorities

The process described starts with company registration and business classification through OSS, followed by basic permits such as location, environmental and building requirements.
The pharmaceutical industry was described as a high-risk business category requiring Ministry of Industry verification for the business license.
After NIB/business licensing, companies may need supporting-business licenses and approvals such as GMP/CPOB, product-related approvals and TKDN certification, depending on the activity.

What Is Most Important for SwissCham Indonesia Members

Raw materials and advanced manufacturing are strong investment opportunities
Swiss companies with capabilities in APIs, excipients, biologics, process technology, quality systems, precision manufacturing and pharmaceutical engineering may fit directly into Indonesia’s upstream-capability gap.
Investment incentives are attractive, but the route is fragmented
Tax incentives, R&D deductions, SEZ benefits and import-duty relief can strengthen the business case. However, the investment process involves multiple authorities. SwissCham can add value by helping members identify the correct entry point and coordinate meetings with the relevant agencies.
TKDN should be assessed before choosing the business model
For pharmaceutical and medical-device companies, the local-content outcome can depend heavily on whether production is in-house, contract-manufactured or jointly manufactured, and on whether raw materials are locally sourced. TKDN should therefore be part of the investment model from the beginning.
Regulatory predictability is as important as incentives
The Q&A showed that established European investors are concerned not only about incentives but also about the cumulative effect of local-content rules, procurement design and changing requirements. This is directly relevant to SwissCham’s policy-dialogue role.
Indonesia wants deeper partnerships, not only imports
The Government is actively encouraging technology transfer, joint ventures, local production, clinical research, co-development and business matching. SwissCham can position Swiss companies as long-term technology and investment partners.
Natural products may offer a different type of Swiss-Indonesian partnership
Because foreign manufacturing investment in natural-based medicines was described as restricted, the more realistic opportunities for Swiss partners are R&D, analytical technology, standardization, clinical evidence, IP development and international market access.
Indonesia must compete with other ASEAN investment destinations
For Swiss companies considering regional manufacturing or expansion, Indonesia’s large domestic market and policy support are advantages, but ease of doing business, regulatory certainty, quality-based procurement and export competitiveness will influence final investment decisions.