BPOM Pharmaceutical Regulations in Indonesia

BPOM (Badan Pengawas Obat dan Makanan), also known as the National Agency of Drug and Food Control (NADFC), is the regulatory authority responsible for pharmaceuticals in Indonesia. It oversees drug registration and other regulatory activities related to pharmaceutical products placed on the Indonesian market.

Pharmaceutical companies must comply with applicable BPOM requirements for product registration and marketing in Indonesia. This article covers the key pharmaceutical regulations, drug registration process, documentation requirements, labeling, fees, timelines, and requirements for imported drugs.

NADFC / BPOM Pharmaceutical Regulations in Indonesia

BPOM regulates pharmaceutical products in Indonesia through a number of regulations covering drug registration, clinical trials, GMP, recalls, and other regulatory activities.

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Local Representative Requirement for Pharmaceutical Registration in Indonesia

In Indonesia, foreign pharmaceutical companies seeking to register their products must work with a local representative. The local representative will be the point of contact between NADFC/BPOM and the foreign company for all regulatory processes. The local representative must be

• An Indonesian-registered legal entity.
• They can be a Pharmaceutical company or Pharmaceutical wholesaler or a Local subsidiary or affiliate.
• Must possess the Drug Distribution License (SIK or Izin PBF) or Production License to manufacture pharmaceutical products in Indonesia

BPOM Classification of Pharmaceuticals in Indonesia

There is a classification system for drugs in Indonesia which was initially based on Permenkes no: 917 in 1993, it was then later revised through Permenkes no: 949/2000. The classification is as follows:

• Free drugs (green circle label)
• Limited Free drug (blue circle label)
• Hard Drugs (red circle label)
• Psychotropic drugs and narcotics

The green and blue circle labelled drugs can be obtained in pharmacies without the need for a prescription.

Pharmaceutical Registration Process in Indonesia

Clinical Trials in Indonesia

Before a new drug is marketed in Indonesia, clinical trial approval may be required depending on the product and development stage. Applications are submitted to BPOM by the sponsor or an authorized clinical research organization along with the required documents.

BPOM Pre-registration Process for Pharmaceuticals

Pre-registration is completed before the main drug registration process. It helps determine the registration category, evaluation pathway, documents required, and applicable fee.

Registration involves the submission and evaluation of the drug application before a marketing authorization can be issued.

Applications for pre-registration and registration can be submitted electronically.

Process flow of pre-registration of drugs

• The applicant must register an account with NADFC/BPOM following which the BPOM verifies and activates the account. Once this is done you can login and request for product ID.
• After the payment of fees and uploading the proof of payment and its verification (by BPOM), a notice of payment will be received via email.
• Fill the pre-registration form and submit the documents. The evaluation process begins, and the applicant can track the status of application.
• If it meets all the requirements, HPR (pre-registration result) approval.

Process flow for registration of drugs

• Applicant must fill out the registration form after choosing the drug to be registered from the HPR data.
• After the verification of the registration form, an SPB (order to pay) registration is issued. Upon making the payment, the proof of payment must be uploaded and once it is verified, the product ID is obtained.
• Now upload all the necessary registration documents. They are then evaluated. The application status can be tracked online. BPOM can either request for additional data or reject the application if the documents are not meeting the requirements.
• An approvable letter and NIE (marketing permit number) is granted if requirements are met.

BPOM Pharmaceutical Registration Categories in Indonesia

BPOM pharmaceutical registration in Indonesia is divided into three main types: new registration, variation registration, and renewal registration. These are further classified into seven categories based on the type of application.

New Registration

• Category 1 is for the registration of New drugs & biological products including biosimilar products.
• Category 2 is for the registration of generic drugs and branded generic drugs.
• Category 3 is for the registration of other preparations that contain special technology (transdermal patch, implants and beads).

Variation Registration: Changes to a drug that has already obtained marketing authorization in Indonesia must be submitted to BPOM through the applicable variation registration pathway. These changes may relate to safety, efficacy, quality, administration, product information, or labeling.

• Category 4 is for the major variation registration
• Category 5 is for minor variation registration
• Category 6 is for notification variation registration

Renewal of Registration

• Category 7 is the registration renewal

BPOM Documentation and Dossier Requirements for Pharmaceutical Registration

BPOM allows pharmaceutical registration dossiers to be submitted using either the ASEAN Common Technical Dossier (ACTD) format or the ICH CTD format. When the ACTD format is used, the dossier is divided into four parts:

• Part I: Administrative documents, product information and labeling
• Part II: Quality Documents
• Part III: Non-clinical documents
• Part IV: Clinical documents

BPOM Dossier Requirements for Different Drug Types

BPOM dossier requirements vary depending on the type of pharmaceutical product being registered. New drugs generally require a full dossier, while generic, biological, and traditional medicines may have different documentation requirements.

New Drugs (Innovative Drugs): Full ACTD dossier including detailed clinical trial data

• Stability Data: Long-term, accelerated, and in-use stability studies are needed.
• Clinical Data: Includes local clinical trials if necessary, or foreign clinical trial data with relevance to the Indonesian population.

Generic Drugs: Generic drug applications generally follow the applicable abbreviated ACTD requirements.

• Bioequivalence Study: Demonstrating therapeutic equivalence to the reference innovator drug (required under Module 5).
• Module 4: Non-clinical studies may not be required for generics.
• Stability Data: Stability testing for the generic formulation.

Biological Products: Products such as vaccines, monoclonal antibodies, blood products require more extensive data due to the complexity of their production.

• Module 3 : (Quality) is significantly expanded for biologics to cover the detailed production process of biological materials.
• Immunogenicity Studies: Specific immunogenicity testing is required to evaluate safety.

Traditional Medicines and Herbal Products: Traditional and herbal products follow a simplified registration process.

• Module 3 is the most critical, focusing on quality and safety of the ingredients, manufacturing processes, and GMP compliance.
• Clinical and non-clinical data may not be required, especially for products with a well-documented history of safe use.

Additional BPOM Dossier Requirements for Imported Drugs

For imported drugs, additional documents must be submitted along with the CTD dossier:

• Certificate of Pharmaceutical Product (CPP), where applicable
• Good Manufacturing Practice (GMP) certificate for the manufacturing facility
• Import-related authorization or documentation, where applicable
• Letter of authorization for the local representative

Dossier Submission Format for Pharmaceuticals in Indonesia

The documents must be submitted in Indonesian or in English language. It can be submitted electronically but manual submission is also accepted in any event the electronic registration cannot be submitted or if the electronic system does not work.

BPOM Labeling Requirements for Pharmaceuticals in Indonesia

All information on the label must be written in Bahasa Indonesia. For imported drugs, a certified translation must be provided. The following information is mandatory for inclusion on all drug labels:

• Product Name
• Composition
• Dosage Form and Strength
• Indications and Uses
• Dosage and Administration
• Contraindications
• Warnings and Precautions
• Adverse Reactions
• Storage Conditions
• Expiry Date and Lot Number
• Registration Number
• Manufacturer Information
• Authorization by BPOM
• Special Symbols and Identification

Classification Labels for Pharmaceuticals in Indonesia

• Green Circle: Over-the-counter (OTC) or free drugs (Obat Bebas).
• Blue Circle: Limited over-the-counter drugs (Obat Bebas Terbatas) with usage restrictions.
• Red Circle with “K”: Prescription drugs (Obat Keras).
• Red Circle with “N”: Narcotic drugs (Obat Narkotika).
• Special Symbols: Additional labeling for psychotropic drugs, traditional medicines, biological products, and generic drugs.

BPOM Registration Fees for Pharmaceuticals in Indonesia

The registration fee depends on the type of pharmaceutical application submitted to BPOM. The amount may vary for new drug applications, generic drugs, biological products, variations, renewals, and other registration services.

The current fee structure is covered under Government Regulation No. 15 of 2026. It replaced Government Regulation No. 32 of 2017 and came into effect in May 2026.

Fees are not the same for every application. They differ based on the type of drug and the registration activity. The latest BPOM tariff should be checked before the application is submitted.

BPOM Pharmaceutical Registration Timelines in Indonesia

Description	Timeline
For new chemical entities, biologics, or innovative drugs.	Up to 300 WD
For generic drugs requiring bioequivalence data.	Up to 150 WD
For priority drugs (orphan, pandemic, public health).	Less than 150 WD
For traditional medicines and herbal products.	Up to 100 WD
For urgent products (e.g., COVID-19 vaccines, treatments).	<100 WD
For foreign products with a local representative.	Varies
For minor variations	40 WD
For Major variations	100-300 WD (Depends on the category and variations)
Registration Renewal	10 WD

WD: Working days

BPOM Requirements for Imported Drugs in Indonesia

Imported pharmaceutical products must meet the applicable BPOM registration and import requirements before they can be marketed in Indonesia.

Who Can Apply?

Registration of imported drugs must be handled through an eligible pharmaceutical company in Indonesia. The applicant must meet BPOM requirements for drug registration and, where applicable, be appointed by the foreign manufacturer or product owner.

For the actual import of finished pharmaceutical products, BPOM states that a pharmaceutical industry or a licensed pharmaceutical wholesaler, known as Pedagang Besar Farmasi (PBF), may import the product when it holds the required marketing authorization.

Requirements for the Foreign Manufacturing Site

For imported drugs, BPOM may require documents relating to the foreign manufacturing facility, including:

• a valid pharmaceutical manufacturing licence or equivalent authorization
• a valid GMP certificate or equivalent document
• the latest full inspection report for the manufacturing facility, generally not older than two years
• a current Site Master File (SMF)
• CAPA information where critical or major observations were identified during the latest inspection
• supporting information on the product and manufacturing facility

BPOM may require further document assessment, desktop inspection, or an on-site inspection where the submitted evidence is not sufficient to demonstrate GMP compliance.

Online Submission and Import Process

Drug registration is handled through BPOM’s electronic drug-registration system. For each physical importation of finished pharmaceutical products, the importer must also obtain the applicable Surat Keterangan Impor (SKI). BPOM states that an SKI is valid for one importation only, so a new application is required for each import.

Validity of BPOM Marketing Authorization

A BPOM marketing authorization for a pharmaceutical product is generally valid for up to five years, provided the applicable regulatory requirements continue to be met. If the authorization is based on an agreement or appointment with a shorter cooperation period, the authorization may follow that shorter period.

Renewal of Pharmaceutical Marketing Authorization in Indonesia

A pharmaceutical marketing authorization can be extended through re-registration before its validity ends. I would not retain the old statement saying the renewal “must not be submitted prior to 12 months and after 2 months” because I could not reconfirm that exact window from the current official BPOM sources I checked. BPOM’s current portal continues to show re-registration or renewal as an active registration pathway.

BPOM PMS and Pharmacovigilance Requirements in Indonesia

Safety monitoring continues after the product is sold in Indonesia. BPOM Regulation No. 4 of 2026 is the current rule for pharmacovigilance and replaces Regulation No. 15 of 2022.

Companies need to keep track of safety issues reported for their products. Adverse drug reactions and periodic safety reports are part of this process.

For products that require a PSUR, the report is submitted every six months for the first two years after approval. After that, it is submitted once a year for the next three years.

BPOM can take further action if any new safety concern is identified after the product is marketed.

Conclusion

Pharmaceutical products in Indonesia have to meet BPOM requirements before and after they enter the market. Registration, labeling, imports, and pharmacovigilance are some of the main areas involved.

For a foreign manufacturer, the local registration route and the Indonesian representative are important parts of the process.

Artixio can support pharmaceutical companies with BPOM registration and regulatory requirements in Indonesia through its regional regulatory experts. Connect with us through info@artixio.com.

FAQs

What Is the Full Form of BPOM?

The name BPOM comes from Badan Pengawas Obat dan Makanan, the Indonesian term used for the country’s drug and food authority.

How Are Pharmaceuticals Registered in Indonesia?

Drug registration in Indonesia is handled through BPOM. What a company has to submit depends on the product and the kind of registration being made.

How Long Is a BPOM Pharmaceutical Marketing Authorization Valid?

The authorization is usually given for five years. If the product is to stay on the market after that, the approval has to be renewed.

What Is BPOM in Indonesia?

BPOM is the authority that handles drug and food control in Indonesia. For medicines, companies deal with BPOM for registration and other regulatory requirements.

Can a Foreign Pharmaceutical Company Register a Drug Directly in Indonesia?

Not usually. A foreign manufacturer works through an eligible Indonesian company for the registration process.