Explained: Indonesia Preliminary Review for Imported Drug Registration

Conducting an Indonesia preliminary review for imported drug registration is the single most critical step you can take before committing time and capital to a full product dossier. While home-country approval is a major milestone, BPOM (Indonesia’s Food and Drug Authority) evaluates compliance through its own strict local parameters.

Governed primarily by BPOM Regulation No. 24 of 2017 (and its recent 2025 updates), the agency looks far beyond international clinical data, focusing heavily on local applicant licensing, priority product categories, and mandatory technology transfer. Uncovering these structural requirements early is the best way to protect your budget and prevent submission delays down the road.

Read on to benchmark your pharmaceutical product’s readiness for Indonesia, or contact Cisema to build a tailored regulatory strategy for imported drugs in Indonesia.

Who Can Apply for Imported Drug Registration in Indonesia?

The first question is whether the proposed local applicant meets BPOM’s requirements. Under BPOM Regulation No. 24 of 2017, the applicant must be an officially recognized "pharmaceutical industry" entity under Indonesian law. While that regulatory phrasing sounds broad, BPOM defines it specifically as a licensed business engaged in the actual manufacturing of drugs or drug substances. In practice, this means your applicant must be a licensed local pharmaceutical manufacturer — a general importer, trading company, or distributor cannot act as the applicant.

An overseas pharmaceutical company does not need to establish its own pharmaceutical manufacturing entity in Indonesia. However, it must appoint a qualified Indonesian pharmaceutical manufacturer to act as the applicant or registrant.

The overseas manufacturers should therefore establish a formal regulatory agreement with its Indonesia partner.  Under Article 15 of BPOM Regulation No. 24 of 2017, the Indonesian applicant must obtain written authorization from the overseas manufacturer, specifying the cooperation period, unless the applicable affiliated-company exemption applies. The overseas manufacturer should also verify that the Indonesian applicant :

• Hold a valid, active Pharmaceutical Industry License issued under Indonesian law
• Are fully licensed for the specific pharmaceutical activities required
• Possess the legal standing to serve as the local Registration Holder and Marketing Authorization Holder
• Fully comply with applicable Good Manufacturing Practice (GMP) standards

Once the local applicant has been confirmed, the next step is to determine whether the product itself falls within a category eligible for imported drug registration.

BPOM Priority Categories for Imported Drugs in Indonesia

Indonesia does not treat all imported drugs in the same way. The company should next assess whether the product falls within a category prioritized for imported drug registration in Indonesia.

Under Article 11(2) of BPOM Regulation No. 24 of 2017, priority for imported drug registration is given to three  categories of medicines:

Priority 1: Drugs for National Health Programs

The first category covers imported drugs used in national health programs. The government institution responsible for the relevant program determines which medicines fall within this category.

Priority 2: New Drugs

Under Article 13, this covers patent-protected medicines and originator drugs — defined as drugs granted initial marketing authorization in Indonesia based on full, comprehensive data covering safety, efficacy, and quality.

Priority 3: High-Need Drugs Not Produced Domestically

Imported drugs may also receive priority when they are needed in Indonesia but cannot be manufactured domestically.

The circumstances described in Article 14 include:

• Drugs requiring specialized technology or manufacturing facilities that are not available in Indonesia.
• Drugs requiring technology or facilities that exist locally but do not have enough capacity to meet demand.
• Drugs that are not economically viable to manufacture locally because they are needed only in small quantities, including certain orphan drugs.
• Drugs manufactured centrally overseas by a multinational pharmaceutical company that owns a pharmaceutical manufacturing company in Indonesia and can demonstrate a balance between its export and import activities.

For products relying on Priority 3, the application should include a formal and evidence-based explanation of why domestic production is not feasible.

Assessing Existing BPOM Drug Registrations and Comparable Products

Priority status is only one part of the eligibility assessment. It is also worth checking what BPOM has already approved.

CekBPOM can be searched using the product name, active ingredient, dosage form, or registration number. Searching by active ingredient and dosage form can reveal comparable products marketed under different brand names.

An existing registration does not automatically determine the outcome of a new application. However, identifying existing registrations and comparable products can help assess the product’s regulatory positing and determine whether additional justification or clarification from BPOM may be necessary. 

With the product and registration structure established, the review can then move to the overseas manufacturer and the evidence required to support its involvement in the Indonesian application.

Overseas Manufacturer Audits & Technology Transfer

After establishing applicant and product eligibility, the preliminary review shifts focus overseas to evaluate the site manufacturing evidence and long-term regulatory compliance.

Document Readiness & Audit Trail

Once baseline eligibility is established, overseas manufacturers must demonstrate their regulatory standing and GMP compliance in accordance with applicable BPOM requirements, including BPOM Regulation No.33 of 2025 on GMP compliance assessments for imported drug manufacturing facilities.

The preliminary review should cover:

• Pharmaceutical Industry License: The license must be issued by the relevant authority in the manufacturer’s home jurisdiction and cover the proposed manufacturing activities.
• Valid GMP Certificate: The certificate or equivalent document must be issued by the local drug regulatory authority or another recognized drug regulatory authority. Its validity, issuing authority, manufacturing site, dosage forms, and activities should align with the Indonesian application.
• Recent Inspection Report (within 2 years): The most recent audit report (and any subsequent corrective actions) issued by your local authority or a recognized regulatory body.

A GMP certificate alone may not be sufficient. BPOM may also review the manufacturer’s recent compliance history. Where necessary, BPOM may conduct an on-site inspection to verify GMP compliance. The assessment should cover the entire manufacturing chain. If different manufacturers are responsible for different stages of production, the relevant requirements may apply to each manufacturing site, not just the facility responsible for the finished product.

Mandatory Technology Transfer Alignment

Under Article 16 of BPOM Regulation No. 24 of 2017, imported drug s covered by Article 14(1) are subject to a gradual technology transfer requirement intended to support future domestic manufacturing in Indonesia. Designed to build long-term local manufacturing capability, this requirement can encompass product development, manufacturing processes, quality control methodologies, or a combination thereof.

Technology transfer may be made to the overseas company's representative in Indonesia or another Indonesian pharmaceutical manufacturer under an agreement between the technology owner and recipient.

The preliminary review should therefore establish whether the overseas manufacturer can provide the necessary technical information and expertise and identify an appropriate Indonesian pharmaceutical manufacturer as the potential technology-transfer recipient.

Common Regulatory Pitfalls

If you take only one thing away from this breakdown, let it be this: great clinical data in your home market won't save a dossier that trips over local admin rules.

When international teams rush into an Indonesian filing, these three "blind spots" usually end up derailing their timeline:

1. Incompatible Local Applicant Licensing: Engaging a local partner who holds a Pharmaceutical Industry License is insufficient if they lack a valid GMP certificate or fail to cover your product's required operational activities.
2. Sub-standard Priority 3 Justifications: Assertions regarding non-feasibility of domestic production must be supported by verifiable data. BPOM strictly scrutinizes generic justifications regarding local capacity or technology constraints.
3. Overlooked Secondary Manufacturing Sites: BPOM evaluates the entire supply chain. Compliance gaps or outdated inspection reports from secondary facilities — such as active pharmaceutical ingredient (API) suppliers or secondary packagers — can delay authorization, regardless of the primary site's standing.

Bottom line: Spending a few weeks running a preliminary review is significantly cheaper than spending six months answering BPOM's requests for information later.

Final Thoughts: Use the Preliminary Review to Stress-Test the Registration Strategy

A product with an exemplary track record in mature reference markets can still encounter significant regulatory friction in Indonesia if local nuances are overlooked. By validating your local applicant, confirming priority categorization, reviewing competitive market precedents, auditing manufacturer GMP data, and mapping out technology transfer pathways, you establish a clear, predictable route to market entry.

Navigating BPOM’s evolving regulatory landscape requires dedicated local expertise. From preliminary feasibility assessments and document-readiness reviews to dossier compilation and direct BPOM liaison, Cisema helps international pharmaceutical companies de-risk market entry and achieve regulatory approval in Indonesia.

For expert guidance with imported drug registration and regulatory strategy in Indonesia, contact Cisema today.

Further Information

• ⁠Read about BPOM’s clarification of the Indonesia–US pharmaceutical trade agreement.
• Explore Cisema’s regulatory affairs services across Asia Pacific.

References

• Regulation of the Chairperson of The Indonesian Food and Drug Authority of the Republic of Indonesia No. 24 of 2017 on Criteria and Procedures for Drug Registration
• BPOM Regulation No. 33 of 2025