Pharmaceutical Registration Indonesia

Who needs this service?

This service is for foreign pharmaceutical manufacturers and licensors, Indonesian pharmaceutical companies adding imported or licensed products, and producers or importers of traditional and herbal medicines. It covers new drugs, generics, biologics, over-the-counter medicines, natural medicines and quasi-drugs.

Check the category before anything else. Health supplements, cosmetics and medical devices follow different routes. See supplement registration, the BPOM product pathways and medical-device registration.

Who can register a medicine

Under BPOM Regulation No. 24 of 2017 on drug registration, most recently amended by Regulation No. 23 of 2025, the registrant must be a licensed pharmaceutical manufacturer (Industri Farmasi). BPOM Regulation No. 27 of 2025 limits the marketing-authorisation standard for drugs to pharmaceutical manufacturing and certain hospital and health-service activities. A distributor or general importer cannot hold a drug registration. See the 2017 regulation and the 2025 amendment.

A foreign company therefore usually works through one of these models:

• An Indonesian pharmaceutical manufacturer as registrant for an imported product, with written approval from the foreign manufacturer.
• An affiliated Indonesian manufacturer of the same group, which is exempt from the written-approval requirement.
• Licensed local production, where an Indonesian manufacturer appointed by the licensor registers the product. It must hold a valid GMP (CPOB) certificate for that dosage form and a licence agreement.

The written approval must state how long the cooperation lasts. A marketing authorisation is valid for up to five years. If the agreement is shorter, the authorisation runs only for the agreement period, and it lapses if the agreement ends early. Plan the partner agreement and the registration together.

Imported medicines: conditions

The 2017 regulation gives imported registration priority to three groups:

• Medicines for national health programmes.
• New or originator medicines, including patented products.
• Medicines that are needed but cannot be produced in Indonesia. Examples include products needing special technology, products where local capacity is insufficient, small-volume products such as orphan drugs, and products made centrally abroad by a multinational with a pharmaceutical company in Indonesia.

An imported registration must include a justification that the product cannot be produced in Indonesia. For the third group, the regulation also expects gradual technology transfer towards local production.

The foreign manufacturer must show a manufacturing licence, a valid GMP certificate and its latest inspection report, issued within the last two years. BPOM assesses the foreign site against Indonesian GMP (CPOB) through document review, a desktop inspection and, where needed, an on-site inspection. See BPOM Regulation No. 27 of 2025.

ATC classification and drug category

BPOM’s drug registration form asks for the therapeutic class and the ATC code. The form must be completed using the WHO Anatomical Therapeutic Chemical (ATC) index, published by the WHO Collaborating Centre for Drug Statistics Methodology. The same form also asks for the drug category: prescription (obat keras), over-the-counter (obat bebas), limited over-the-counter (obat bebas terbatas), narcotic or psychotropic. See the current registration form (2025 amendment).

An ATC code classifies the active substance at five levels, from the anatomical main group down to the chemical substance. For example, plain metformin is A10BA02. Combination products, new substances and products with several uses need care. Not every substance is in the index yet, and the WHO Centre adds new entries on request from manufacturers, regulators and researchers. See the WHO explanation of the ATC structure.

MDM reviews the proposed ATC code, therapeutic class and drug category for each product, checks them for consistency with the product information and labels, and prepares a request to the WHO Centre where a substance has no code yet.

Herbal medicines and quasi-drugs

Natural medicines (Obat Bahan Alam) follow a separate registration route. This category covers jamu, standardised herbal medicines, phytopharmaceuticals and other natural medicines, including imported ones. Unlike drugs, they can be registered by traditional-medicine manufacturers and by licensed pharmaceutical or traditional-medicine wholesalers, which makes the route practical for importers.

Registration starts with pre-registration. BPOM’s maximum review period for an imported natural medicine is 90 working days. Quasi-drugs (obat kuasi) follow their own standard, which is also open to wholesalers and cosmetic manufacturers. Applications for both run through BPOM’s ASROT system. Open ASROT.

Review timelines

BPOM Regulation No. 27 of 2025 sets maximum review periods in working days. The clock stops while BPOM waits for your answers to its questions.

• Pre-registration: 40 days.
• New drug or biologic already approved in at least one country with a well-established evaluation system: 90 days.
• Life-saving, orphan or national-programme medicines: 100 days.
• Generics and branded generics outside the faster tracks: 150 days.
• New drugs and biologics outside the faster tracks: 300 days.
• Renewal: 10 days. Foreign-site GMP: document review 15 days, desktop inspection 20 days.

These are review times only. Dossier preparation, foreign GMP evidence, partner agreements and BPOM’s questions usually take longer, so plan them first.

Documents to prepare

• Administrative: the registrant’s licences and certificates, the foreign manufacturer’s licence, GMP certificate and recent inspection report, and the written approval or licence agreement with its term.
• Quality: data on the active substance and finished product (CTD format), specifications, stability and manufacturing information.
• Safety and efficacy: non-clinical and clinical data appropriate to the product type, or bioequivalence data for generics.
• Classification: the proposed ATC code, therapeutic class and drug category for each product.
• Labelling: Indonesian product information, patient information and label texts.
• Regulatory history: approvals in other countries, which can support the faster evaluation routes.

This is a scoping list. The exact dossier depends on the product category and the registration route.

How MDM supports the project

1. Classify the product. Confirm whether it is a drug, biologic, natural medicine, quasi-drug or another category, and confirm its ATC code and drug category.
2. Choose the registrant model. Compare an Indonesian partner manufacturer, an affiliate or a licence, and the agreement terms each needs.
3. Run a gap analysis. Check the dossier, GMP evidence and labelling against BPOM requirements.
4. Coordinate submission. Support pre-registration, registration and BPOM’s questions within the agreed engagement.
5. Plan obligations after approval. Prepare for import permits, distribution through licensed distributors, pharmacovigilance, variations and renewals.

BPOM makes the regulatory decision. MDM coordinates and advises but does not act as registrant.

After approval

The registrant must start producing or importing the medicine within one year of approval. It must also monitor safety and report adverse reactions to BPOM, and register any changes as variations before the authorisation is renewed.

Medicines reach the market through licensed pharmaceutical wholesalers (PBF) certified for Good Distribution Practice (CDOB). Each PBF needs a responsible pharmacist. Check your distributor’s certification early.

Issues to review early

• The proposed partner is a distributor, not a pharmaceutical manufacturer, so it cannot register the drug.
• The cooperation agreement is short, which shortens the marketing authorisation.
• Ending the partner agreement cancels the authorisation, so the exit plan needs thought.
• The foreign GMP certificate or inspection report is out of date.
• There is no justification for importing rather than producing locally.
• The product is wrongly classified, for example a herbal product presented as a drug, or the reverse.

Frequently asked questions

Related services

BPOM Registration Indonesia · Supplement Registration Indonesia · Medical Device Registration Indonesia · Import License Indonesia

Official references

• BPOM Regulation No. 24 of 2017 on drug registration (JDIH BPK)
• BPOM Regulation No. 23 of 2025, fifth amendment (JDIH BPK)
• BPOM Regulation No. 27 of 2025, licensing standards for drugs and food, including review timelines (JDIH BPK)
• BPOM — drug registration portal
• WHO Collaborating Centre — ATC/DDD index
• BPOM — ASROT registration system for natural medicines, quasi-drugs and supplements

This page summarises the rules as of October 2026. Requirements depend on the product category, so confirm the applicable route for each product.