Life Sciences 2025 Comparisons

Legislation and Regulation

The primary legislation governing pharmaceuticals and medical devices is Law No 17 of 2023 on Health (“Law 17/2023”). This legislation is implemented through regulations on pharmaceuticals issued by the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, or BPOM) as well as regulations on medical devices issued by the Minister of Health (MOH). On 26 July 2024, the government issued Government Regulation (GR) No 28 of 2024 on Implementing Regulation of Law Number 17 of 2023 on Health (“GR 28/2024”).

Pharmaceuticals

Key regulations for pharmaceuticals include:

• BPOM Regulation No 8 of 2024 on Procedures for the Approval of Clinical Trials Implementation (“BPOM 8/2024”);
• BPOM Regulation No 27 of 2022 on Supervision of Drug and Food Imports into Indonesia, as amended by BPOM Regulation No 28 of 2023 (“BPOM 27/2022 as amended”);
• BPOM Regulation No 2 of 2021 on Guidelines for Drug Advertising Supervision (“BPOM 2/2021”);
• BPOM Regulation No 14 of 2024 on the Supervision of Drugs and Food Distributed Online (“BPOM 14/2024”);
• BPOM Regulation No 7 of 2024 on Good Manufacturing Practice for Pharmaceuticals;
• BPOM Regulation No 10 of 2021 on Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Drug and Food Sector;
• Head of BPOM Regulation No 24 of 2017 on Criteria and Procedures for Drug Registration, as last amended by BPOM Regulation No 15 of 2023 (“H.BPOM 24/2017 as amended”); and
• MOH Regulation No 98 of 2015 on the Provision of Information on Maximum Retail Price of Medicines (“MOH 98/2015”);

Medical devices

Key regulations for medical devices include:

• MOH Regulation No 14 of 2021 on Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Health Sector, as lastly amended by MOH Regulation No 17 of 2024 (“MOH 14/2021”);
• MOH Regulation No 51 of 2014 on the Importation of Medical Devices through the Special Access Scheme as amended by MOH Regulation No 7 of 2020 (“MOH 51/2014 as amended”);
• MOH Regulation No 24 of 2022 on Medical Records (“MOH 24/2022”);
• MOH Regulation No 20 of 2019 on the Implementation of Telemedicine Services between Healthcare Facilities (“MOH 20/2019”);
• MOH Regulation No 62 of 2017 on Marketing Authorisation for Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies (“MOH 62/2017”);
• MOH Regulation No 63 of 2017 on Good Clinical Practice for Medical Devices (“MOH 63/2017”);
• MOH Regulation No 17 of 2017 on Action Plan for the Development of the Pharmaceutical and Medical Equipment Industry (“MOH 17/2017”);
• MOH Regulation No 76 of 2013 on Advertising of Medical Devices and Household Health Supplies (“MOH 76/2013”);
• MOH Regulation No 20 of 2017 on Good Manufacturing Practices for Medical Devices and Household Health Supplies (“MOH 20/2017”);
• MOH Regulation No 1189/MENKES/PER/VIII/2010 Year 2010 on Production of Medical Devices and Household Health Supplies as partially revoked by MOH Regulation No 26 2018 on Electronic Integrated Business Licensing Services in the Health Sector (“MOH 1189/2010”); and
• MOH Regulation No 4 of 2014 on Good Distribution Practice for Medical Devices (“MOH 4/2014”).

Regulatory Bodies

Pharmaceuticals

The BPOM is the primary regulatory body responsible for the supervision and regulation of pharmaceuticals in Indonesia. The BPOM operates under Presidential Regulation (PR) No 80 of 2017 on Indonesian Food and Drug Authority (“PR 80/2017”) and is a non-ministerial government institution tasked with overseeing drug control. Under PR 80/2017, the BPOM operates under and is accountable to the President through the MOH.

Medical devices

The MOH is the primary regulatory body responsible for the supervision and regulation of medical devices in Indonesia. As part of the central government, it operates under PR No 161 of 2024 on Ministry of Health (“PR 161/2024”). Under PR 161/2024, the MOH formulates and enforces health policies, including those related to medical devices.

Under Law No 5 of 1986 on the State Administrative Court, as lastly amended by Law No 51 of 2009 (“Law 5/1986 as amended”), there exists a legal avenue for challenging administrative decisions. This legislation allows any party who believes that their rights have been infringed upon by a state administrative decision to file a lawsuit in the State Administrative Court (Pengadilan Tata Usaha Negara, or PTUN).

For a decision to be the object of a PTUN lawsuit, it must meet the criteria of being concrete, individual and final. The BPOM is a governmental agency responsible for regulating and controlling drugs and food products, whereas the MOH is responsible for regulating and controlling medical devices. As such, the BPOM’s and the MOH’s decisions are considered state administrative decisions. These decisions can be challenged in the State Administrative Court, provided they meet the aforementioned criteria.

To challenge a BPOM and MOH decision, the claimant must demonstrate that the decision directly affects their legal rights or interests and is flawed either procedurally or substantively. The lawsuit must be filed within 90 days from when the decision was issued or became known to the claimant. The State Administrative Court will then review the case to determine the legality and justification of the decision. If the court deems the decision unlawful, it can annul the decision and order corrective actions.

Pharmaceuticals

Under Law 17/2023 and GR 28/2024, drugs are categorised into prescription-only drugs and non-prescription drugs.

Prescription-only drugs consist of potent drugs, narcotics, and psychotropics, which must be dispensed exclusively by licensed pharmacists operating within a pharmaceutical service facilities. Non-prescription drugs, which are further divided into OTC drugs and limited OTC drugs, may be obtained from pharmaceutical service facilities or other facilities in accordance with laws and regulations.

Law 17/2023 provides that certain potent drugs may be dispensed by a pharmacist without a prescription. Under GR 28/2024, these drugs are specified in a list issued by the MOH and reviewed based on developments in healthcare needs, science, and technology.

In addition to these categories, Law 17/2023 also delineates the classification of natural medicines into traditional herbal remedies (jamu), standardised herbal medicines, phytopharmaceuticals, and other natural medicines.

Medical Devices

Based on the risk posed to patients by the use of medical devices, MOH 62/2017 categorises medical devices into Class A (low risk), Class B (low-to-moderate risk), Class C (moderate-to-high risk) and Class D (high risk).

For in vitro diagnostic medical devices, MOH 62/2017 provides classification based on the risk posed by misinterpretation of diagnostic results to individuals and the public – ie, Class A (low risk both to individuals and the public), Class B (moderate risk to individuals but low risk to the public), Class C (high risk to individuals but moderate risk to the public), and Class D (high risk both to individuals and the public).

Pharmaceuticals

Under BPOM 8/2024, clinical trials of pharmaceuticals are differentiated into pre-marketing clinical trials and post-marketing clinical trials. Conducting both types of clinical trials requires prior approval from the head of the BPOM (except for post-marketing clinical trials that are specifically undertaken in Indonesia for educational purposes). Such approval is valid for two years from the date of issuance.

Medical Devices

Similarly, MOH 63/2017 differentiates clinical trials of medical devices into pre-marketing clinical trials and post-marketing clinical trials. Conducting pre-marketing clinical trials requires prior approval from the MOH. Such approval is valid for two years from the date of issuance. In contrast, a notification to the Director General of Pharmaceuticals and Medical Devices (DGPMD) under the MOH will suffice for conducting post-marketing clinical trials.

Pharmaceuticals

To secure authorisation to undertake a clinical trial of a pharmaceutical, the applicant must first submit an electronic application to obtain approval from the head of  the BPOM through the official BPOM website by filing the prerequisite documents and paying the service fees. The BPOM will then evaluate the documents and may request for a correction to be made and/or additional data to be provided. If the BPOM deems no correction and/or additional data is necessary, the BPOM will issue either an approval or a refusal of the application within 20 working days from the date of service fees payment. Approval from the head of the BPOM to undertake a clinical trial will only be given after an approval from the Health Research Ethics Committee is obtained.

Medical Devices

Pre-marketing clinical trials

To secure authorisation to undertake a pre-marketing clinical trial of a medical device, the applicant must first submit a written application to attain approval from the MOH by filing the prerequisite documents to the DGPMD under the MOH and paying the service fees. If the documents are deemed to be complete, the DGPMD will then form an evaluation team that will conduct an evaluation of the documents and deliver the result of the evaluation to the DGPMD. The DGPMD will issue an approval, refusal or deferment for the application within 20 working days from the date of the receipt of the documents filed. An approval from the Health Research Ethics Committee must be obtained prior to submitting a pre-marketing clinical trials application.

Post-marketing clinical trials

To secure authorisation to undertake a post-marketing clinical trial of a medical device, the applicant must first submit a written notification to the DGPMD under the MOH by filing the prerequisite documents. The DGPMD will then give a response to the notification within 20 working days from the date of the receipt of the documents filed. If the DGPMD does not provide a response within the stipulated time, the applicant may draw up a statement confirming readiness to undertake the post-marketing clinical. Approval from the Health Research Ethics Committee must be obtained prior to submitting a post-marketing clinical trials notification.

The conduct and results of a clinical trial both for medicines and medical devices will not be listed in any publicly accessible database. The data generated by clinical trial institutions (eg, hospitals, research centres, and universities) is safeguarded and retained exclusively within these entities, ensuring that no external party is authorised to access such information.

In practice, the release of clinical trial data requires the explicit consent of all parties involved. For instance, in the event of a serious adverse incident, the data may be disclosed solely by mutual agreement for evidentiary purposes. The dissemination of such data is strictly confined to the directly involved parties, maintaining the integrity and confidentiality of the clinical trial process.

There are no restrictions for using online tools to support clinical trials (eg, for recruiting or monitoring purposes).

If the data generated from clinical trials can be used to identify an individual, it is deemed as personal data under Law No 27 of 2022 on Personal Data Protection (“Law 27/2022”). Under Law 27/2022, any transfer of personal data to an external entity is strictly prohibited unless consent has been obtained from the data subject.

Additionally, Article 1(9) of BPOM 8/2024 and Article 1(6) of MOH 63/2017 affirm that the confidentiality of information relating to individuals participating in clinical trials of pharmaceuticals and medical devices is part of the Good Clinical Practice standard (Cara Uji Klinis Yang Baik), which must be complied with in conducting clinical trials.

Under Law 27/2022, the creation of a database containing personal information requires the explicit consent of the data subject.

Further, GR 28/2024 provides that health information system providers must store health data and health information in a database that is located in a safe place and is not damaged or easily lost by using electronic and/or non-electronic storage media. These databases may utilise servers, cloud computing systems, or other storage media in accordance with technological development. Such database must be hosted in a data centre located within the territory of Indonesia. Although storage services and facilities owned by a third party may be used, such arrangements must adhere to the following conditions:

• the storage must be implemented within Indonesia’s jurisdiction;
• a formal co-operation agreement must be in place, which contains at least provisions on confidentiality, service level, and service level target;
• the health data and information are owned and fully controlled by the health information system provider; and
• the data processor must fulfill all data processor obligations under Indonesian law.

Under Law 17/2023, medical devices are defined as instruments, apparatus, machines, equipment, implants, in vitro reagents and calibrators, software, and materials or similar that are used on humans for medical purposes and do not achieve their primary action through pharmacological, immunological, or metabolic processes.

In contrast, drugs are defined as substances or mixtures thereof (including biological products) that are intended for human consumption to influence or examine physiological systems or pathological conditions for the purposes of diagnosis, prevention, treatment, recovery, health improvement, and contraception.

Biological products (eg, vaccines) fall within the definition of drugs and thus fall under the same regulations.

Pharmaceuticals

Marketing authorisation for pharmaceuticals is issued with a maximum validity period of five years. Renewal of marketing authorisation for a pharmaceutical must be submitted no earlier than 12 months and no later than two months before the current authorisation expires. Marketing authorisations for pharmaceuticals can be suspended and/or revoked in the event of:

• violation of the obligation to make and send a production report or import report of imported drugs to the BPOM in accordance with laws and regulations;
• revocation of the industrial licence of the marketing authorisation owner; or
• the marketing authorisation owner committing a violation in the field of production, distribution, promotion, and/or drug labelling.

Medical Devices

Marketing authorisation for medical devices is issued with a maximum validity period of five years. Renewal of marketing authorisation for a medical device must be submitted no earlier than nine months before the current authorisation expires. Marketing authorisation for medical devices can be revoked in the event of:

• the medical devices causing consequences that may endanger health;
• the medical devices not meeting the criteria in accordance with the data submitted at the time of the application for the marketing authorisation registration;
• the product certificate is revoked;
• the medical device distribution licence is revoked; or
• termination of appointment as sole agent/sole distributor/exclusive distributor and/or authorisation.

Pharmaceuticals

To obtain a marketing authorisation for pharmaceuticals, the registration process must be conducted with the BPOM through the Risk-Based Approach Online Single Submission (RBA OSS) system. Only pharma manufacturing companies established in Indonesia can apply for registration.

The registration process for new products is classified into three categories:

• category 1 covers new drugs and biological products, including biosimilars;
• category 2 covers generic drugs and branded generic drugs; and
• category 3 covers other drug-containing products with special technology (eg, transdermal patches, implants and beads).

For new product registration of category 1, risk management planning is mandatory. The procedures and requirements for registration are outlined in H.BPOM 24/2017 as amended.

The registration process for variation is classified into three categories:

• category 4 covers major variations – ie, variations that have a significant effect on the efficacy, safety and/or quality of the drug;
• category 5 covers minor variations – ie, variations that do not fall under the category of either major variation or notification variation registration; and
• category 6 covers notification variations – ie, variations that have minimal or no effect on the efficacy, safety and/or quality of the drug.

The registration process for the foregoing generally consists of two stages – namely, the pre-registration phase and the registration phase. The pre-registration phase filters the registration process by determining the registration category, evaluation track, evaluation fee, and required documents.

Medical Devices

Applications to obtain marketing authorisations for medical devices and in vitro diagnostic medical devices are submitted online through the RBA OSS system and the MOH electronic system. The application includes submission of administrative and technical requirements, including a certificate of production/medical device distribution licence, certificate of free sale, quality management system document, and product information.

The MOH then evaluates and verifies the administrative and technical requirements of the application. If the medical devices involve new technology, active substances, or uncommon claims, a review by a designated expert team may be required.

If the administrative and technical requirements are fulfilled and the documents are complete, the marketing authorisation is issued electronically within a specified timeframe. Otherwise, the MOH will issue a refusal letter. If additional information is required, the MOH will notify the applicant to provide the necessary details or documents.

Variation in the marketing authorisation must be conducted in the event there is a variation in:

• the size, packaging or marking of the product;
• accessories/attachments to the marketing authorisation; or
• the name or address of the representative authorised by the manufacturer.

If there are variations other than the foregoing, the marketing authorisation holder must apply for a new marketing authorisation.

Applications for a variation in the marketing authorisation for medical devices are submitted online through the MOH electronic system and fulfil administrative and technical requirements.

In principle, medical devices and in vitro diagnostic medical devices that are produced, imported, assembled, and/or repackaged must have a marketing authorisation to be distributed within Indonesia. However, MOH 62/2017 provides specific exemptions to this requirement:

• medical devices that enter Indonesia through a special access scheme (SAS) in accordance with laws and regulations;
• certain medical devices and in vitro diagnostic medical devices produced by household companies; and/or
• medical devices and in vitro diagnostic medical devices for certain reasons determined by the MOH.

Pharmaceuticals that enter Indonesia through the SAS in accordance with laws and regulations are exempted from the requirement for a marketing authorisation. In the event of a public health emergency, the marketing authorisation may be in the form of an emergency use authorisation (EUA), which is only effective for use of drugs during the public health emergency and for patient medications in accordance with laws and regulations.

Pharmaceuticals

A holder of a marketing authorisation for pharmaceuticals is required to submit production reports or import reports to the BPOM. They are also obliged to monitor the efficacy, safety and quality of the drug and report the result to the BPOM. Such data can trigger the BPOM to conduct a drug reassessment, which can result in:

• change of label;
• revision of composition/formula;
• provision of limitation of use;
• change in classification of the drug;
• withdrawal of the drug from circulation;
• suspension or revocation of the marketing authorisation.

Medical Devices

Manufacturers and distributors of medical devices or in vitro diagnostic medical devices that will be distributed must include markings and information on the medical devices in accordance with laws and regulations. The information that must be provided includes safety, usefulness, instructions for use, and/or other necessary information, such as trade name, marketing authorisation number, product specification, expiration date and – if applicable – a “For Professional Use Only” warning label.

Additionally, if applicable, information on net content, composition and levels of active ingredients, contraindications, cautions and warning signs or serious adverse events/side effects must be included in the marking and information. The marking and information are prohibited from including certain contents – for example, using superlative words such as “very”, “top” and “super” and mentioning the name of the test lab.

Holders of a marketing authorisation must submit reports including production reports or distribution reports to the MOH. They must also submit an adverse event report if an adverse event occurs.

Manufacturers and distributors of medical devices and in vitro diagnostic medical devices must supervise their products and ensure conformity to standards of quality, safety, and usefulness. The supervision can take the form of audit, re-examination of products to determine serious adverse events, and reporting serious adverse events to the government.

Information relating to pending applications for marketing authorisations both for pharmaceuticals and medical devices is not made available to, and thus cannot be accessed by, third parties. Specifically with regard to pharmaceuticals, Article 27(4) of H.BPOM 24/2017 as amended provides that any information submitted to the BPOM for the purpose of applying for marketing authorisation is strictly confidential and may only be used solely for evaluation purposes by authorised parties.

The BPOM provides a website where third parties can access information concerning the status of marketing authorisations (ie, whether the said authorisation is active, suspended, or has been revoked).

Article 1(9) of BPOM 8/2024 and Article 1(6) of MOH 63/2017 affirm that the confidentiality of information relating to individuals participating in clinical trials of pharmaceuticals and medical devices is an integral part of the Good Clinical Practice standard, which must be adhered to when conducting clinical trials. Additionally, the Appendix to BPOM 8/2024 and the Appendix to MOH 63/2017 further clarify that clinical trials must keep confidential all information relating to individuals participating in clinical trials. Researchers may also be instructed to maintain the confidentiality of any information relating to pharmaceuticals and medical devices.

Medical Devices

In Indonesia, there is no fast track registration route for medical devices. The registration process must adhere to the procedures set forth by MOH 62/2017. The regulation requires all devices to undergo evaluation based on their risk classification (Class A, B, C, or D), with corresponding timelines and requirements.

For domestically produced devices, the evaluation timelines are as follows:

• Class A (low risk) – maximum ten days;
• Class B (low-to-moderate risk) – maximum 20 days;
• Class C (moderate-to-high risk) – maximum 20 days; and
• Class D (high risk) – maximum 30 days.

For imported devices, the evaluation timelines are as follows:

• Class A (low risk) – maximum 15 days;
• Class B (low-to-moderate risk) – maximum 30 days;
• Class C (moderate-to-high risk) – maximum 30 days; and
• Class D (high risk) – maximum 45 days.

After all administrative and technical requirements are deemed complete and compliant, the MOH will issue the marketing authorisation within ten days. In practice, the above timelines can be longer.

Notably, during the COVID-19 pandemic, a temporary fast track registration process (EUA) was introduced under the COVID-19 EUA Guidelines issued by the MOH in 2021. Under the COVID-19 EUA Guidelines, the evaluation timeline for Class A, Class B and Class C would only be ten days. However, this process only applied to certain types of medical device products determined under the COVID-19 EUA Guidelines, such as N95 masks, surgeons’ gloves, oxygen masks, and portable oxygen generators. However, as the pandemic emergency has resolved, the registration process has reverted to the standard procedures outlined in MOH 62/2017.

Pharmaceuticals

For pharmaceuticals, although no fast track mechanism exists, the BPOM embraces the notion of regulatory reliance (see 4.2 Regulatory Reliance), which streamlines the authorisation process for pharmaceuticals.

Pharmaceuticals

Indonesia has embraced the notion of regulatory reliance to streamline its drug authorisation process. Under BPOM 24/2017, the evaluation for registration of a medicine can take 300 business days. However, if the medicine has been approved in at least one country with a well-established evaluation system, the evaluation for registration of such medicine can be expedited to only 120 business days. This expedited timeline applies specifically to registrations of new medicines and registration of major variations with new indications or posology for biological products and new chemical drugs.

Medical Devices

Indonesia does not embrace the notion of regulatory reliance for the medical device authorisation process. Consequently, despite having obtained authorisations in a country with a well-established evaluation system, all products and establishments must still undergo local authorisation processes in adherence to MOH 62/2017.

Pharmaceuticals

The manufacturing of pharmaceuticals is subject to authorisation from the Ministry of Industry (MOI) and the BPOM. Companies must obtain a standard certificate from the MOI and a Good Manufacturing Practice for Pharmaceuticals (Cara Pembuatan Obat yang Baik, or CPOB) certificate from the BPOM. The process to obtain both authorisations is conducted online through the RBA OSS system. For the standard certificate application, the RBA OSS system will then redirect to the MOI electronic system. For the CPOB certificate application, the RBA OSS system will redirect to the BPOM electronic system. The standard certificate and the CPOB certificate authorise the company to conduct manufacturing of pharmaceuticals pursuant to their Indonesian Business Classification Code (Klasifikasi Baku Lapangan Usaha Indonesia, or KBLI).

The period of validity of both the standard certificate and the CPOB certificate is five years and can be extended.

Medical Devices

The manufacturing of medical devices is subject to an authorisation. Companies must obtain a Good Manufacturing Practice for Medical Devices (Cara Pembuatan Alat Kesehatan yang Baik, or CPAKB) certificate and a manufacturing licence. The process to obtain a CPAKB certificate and a manufacturing licence is conducted online. The CPAKB certificate and the manufacturing licence authorise the company to conduct the manufacturing of medical devices pursuant to their KBLI. The period of validity of both the CPAKB certificate and manufacturing licence is five years and can be extended.

Pharmaceuticals

The wholesale of pharmaceuticals is subject to authorisation from the BPOM and the MOH. Companies must obtain a Good Distribution Practice for Pharmaceuticals (Cara Distribusi Obat yang Baik, or CDOB) certificate from the BPOM and a wholesaler licence from the MOH. The process to obtain a CDOB certificate is conducted online through the RBA OSS system and the BPOM electronic system, whereas the process to obtain a wholesaler licence is conducted through the RBA OSS system and the MOH electronic system. The CDOB certificate authorises the company to conduct the wholesale of pharmaceuticals pursuant to their Indonesian KBLI. The period of validity of both the CDOB certificate and the wholesaler licence is five years and can be extended.

Medical Devices

The wholesale of medical devices is subject to authorisation from the MOH. Companies must obtain a Good Distribution Practice for Medical Devices (Cara Distribusi Alat Kesehatan yang Baik, or CDAKB) certificate and a distribution licence from the MOH. The process to obtain a CDAKB certificate and a distribution licence from the MOH is conducted online through the RBA OSS system and the MOH’s electronic system. The CDAKB certificate and the distribution licence authorises the company to conduct the wholesale of medical devices pursuant to their KBLI. The period of validity of both the CDAKB certificate and the distribution licence is five years and can be extended.

See 1.3 Different Categories of Pharmaceuticals and Medical Devices.

The import and export of pharmaceuticals and medical devices in Indonesia are primarily overseen by the Minister of Trade (MOT), the MOH, and the BPOM.

The primary regulation for imports is the MOT Regulation No 36 of 2023 on Import Policy and Provisions, as lastly amended by MOT Regulation No 8 of 2024 (“MOT 36/2023 as amended”), which outlines the requirements and procedures for importing goods into Indonesia. For exports, the primary regulation is MOT Regulation No 23 of 2023 on Export Policy and Provisions, as lastly amended by MOT Regulation No 21 of 2024.

In the health sector, the MOH and the BPOM play crucial roles in applying and enforcing the import regulations of pharmaceuticals and medical devices. For instance, the BPOM is responsible for issuing marketing authorisations for pharmaceuticals and oversees the adherence to these authorisations at the point of entry and beyond.

At the point of entry, the Indonesian customs collaborates with the MOT, the MOH, and the BPOM to inspect and verify the compliance of imported pharmaceuticals and medical devices with all relevant regulations. After entry, the BPOM and the MOH continue to monitor and enforce compliance through routine inspections and market surveillance.

Any legal entity with a valid import business licence can act as the importer of record for pharmaceuticals and medical devices. However, the import of certain products requires specific documents issued by the relevant authorities (see 7.3 Prior Authorisations for the Importation of Pharmaceuticals and Medical Devices).

The import of pharmaceuticals and medical devices requires marketing authorisation of the products (see 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations). The import of pharmaceuticals also requires an import certificate (surat keterangan impor, or SKI) from the BPOM. Additionally, certain products require an import approval and/or surveyor report under the MOT 36/2023 as amended.

BPOM 27/2022 as amended provides that pharmaceuticals without marketing authorisation may be imported into Indonesia for certain purposes, such as:

• personal use;
• research;
• product and/or scientific development;
• donation;
• sample for marketing authorisation applications;
• clinical trials for registration requirements, product development, and/or scientific purposes;
• government programmes;
• urgent national interests;
• special use for healthcare services that cannot be produced domestically; and
• exhibitions.

MOH 14/2021 provides that the MOH may issue statement letters addressed to the Indonesian customs to explain that the imported products are raw materials, spare parts, or samples that will be used for the purpose of applying for marketing authorisation. Further, please note that – in importing such products – a statement letter from the MOT may also be required.

Non-tariff regulations and restrictions in Indonesia are imposed based on the harmonised system (HS) codes of the goods. The types of products subject to non-tariff regulations and restrictions are listed in the Ministry of Finance (MOF) regulation – specifically, MOF Regulation No 26/PMK.010/2022 of 2022, as amended by MOF Regulation No 10 of 2024.

Indonesia is a member of the Association of Southeast Asian Nations (ASEAN) and the following free trade agreements that contain provisions on trade/regulatory facilitation. Three notable examples include:

• the ASEAN Trade in Goods Agreement (ATIGA);
• the ASEAN–Australia–New Zealand Free Trade Agreement (AANZFTA);
• the Regional Comprehensive Economic Partnership (RCEP).

Pharmaceuticals

The prices for pharmaceuticals in Indonesia are regulated to ensure affordability and accessibility, primarily governed by MOH 98/2015. Under this regulation, pharma industries are required to provide information on the highest retail price on the drug’s label – either as a nominal value in Indonesian rupiah or as a formula, depending on the type of drug. This regulation covers generic drugs listed in the e-catalogue for government procurement, generic drugs not listed in the e-catalogue, and drugs other than generic drugs.

For generic drugs not listed in the e-catalogue and drugs other than generic drugs, the highest retail price must be in the form of a nominal value. The highest retail price is 128% of the HNA (harga netto apotek, or pharmacy net price), which is the price given by the pharmaceutical wholesaler to the pharmacies plus VAT. For generic drugs listed in the e-catalogue, the highest retail price will be in the form of a formula of the highest retail price.

Pharmacies, drug stores, and hospital or clinic pharmaceutical installations are required to sell drugs at prices equal to or lower than the highest retail price indicated on the label. If the price provided on the label is no longer valid, they must adjust accordingly to comply with current regulations.

Medical Devices

There is no specific regulation on pricing for medical devices.

The price levels of pharmaceuticals and medical devices in Indonesia do not generally depend on the prices for the same products in other countries but rather are mainly determined by the production cost and the variables introduced by the importation process. The government has previously expressed concerns about the high price of certain imported pharmaceutical materials, which is caused by the fluctuating exchange rates, in the Appendix to MOH 17/2017.

In 2023, the MOH conducted a focus group discussion regarding access to and production of innovative drugs, comparing drug prices in Indonesia with those in other countries.

While there is no specific regulation directly addressing the reimbursement of pharmaceuticals and medical devices, the public healthcare system is effectively managed by BPJS Health (Badan Penyelenggara Jaminan Sosial Kesehatan), an independent authority established to administer the national health insurance programme.

BPJS Health mandates that every Indonesian citizen participates in the health security programme, regardless of any existing health insurance policies they may hold. It collects periodic contribution fees from all enrolled participants. These contributions are structured based on income levels.

BPJS Health’s coverage encompasses a wide range of health services, including the costs associated with pharmaceuticals and medical devices.

The extent and circumstances under which these costs are reimbursed from public funds are determined by the policies and operational guidelines set forth by BPJS Health.

There is no specific regulation that governs the application of cost-benefit analysis in determining what price should be paid for pharmaceuticals or medical devices or in determining whether pharmaceuticals or medical devices should be reimbursed.

The regulations concerning prescriptions by physicians and dispensing by pharmacies are not aimed at curbing spending on pharmaceuticals but, rather, at ensuring the safety of patients and protecting the community from the circulation of unsafe drugs.

Pursuant to Article 320 of Law 17/2023, there are three types of drugs where a prescription is mandatory – namely, potent drugs (obat keras), narcotics, and psychotropics. The dispensing of prescription drugs that circumvent the prescription requirement risks imprisonment of up to 12 years and fine of up to IDR5 billion. Additionally, the illegal distribution of narcotics and psychotropics carries a severe penalty, whereby the death penalty may be imposed in certain circumstances.