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Pharmaceutical Registration in Indonesia

Bringing a pharmaceutical product to the Indonesian market means navigating one of Southeast Asia's most demanding regulatory environments. PRI manages your pharmaceutical product registration from pre-submission through BPOM approval, and serves as your licensed Local Authorised Representative throughout the process.

Pharmaceutical Product Registration (BPOM / NIE)

We manage end-to-end submission and evaluation follow-up with BPOM, handle clarification responses, and monitor every stage of the evaluation cycle through to Marketing Authorization (Nomor Izin Edar / NIE) approval.

Pre-Registration & Dossier Preparation

We scope your registration pathway through BPOM's Pre-Registration (Pra-Registrasi) stage and prepare your complete pharmaceutical registration dossier, covering all technical, quality, and administrative documents aligned to BPOM and CTD standards.

BA/BE Testing Coordination

Generic pharmaceutical products in Indonesia require a Bioequivalence (BA/BE) study at an Indonesian-accredited facility. We coordinate the full BA/BE process, from study planning and site selection through to report integration into your registration dossier.

Local Authorised Representative (LAR)

Foreign pharmaceutical manufacturers must register through a licensed local entity in Indonesia. PRI serves as your Local Authorised Representative, holding your NIE independently of any distributor arrangement and giving you full commercial flexibility in the Indonesian market.

シームレスなコンプライアンスサポート

エンドツーエンドのサービス

当社は、ライセンスから製品登録までの規制の全過程を管理します。.

規制に関する専門知識

当社のチームは、深い知識と経験を組み合わせて、複雑な規制環境に対応します。.

スピードと効率

当社の実績ある戦略により、インドネシア市場における登録および承認のプロセスが加速されます。.

カスタマイズされたサポート

スムーズで安心できる旅を実現するために、個別のガイダンスと専用のサポートを提供します。.

End-to-End Pharmaceutical Registration Support in Indonesia

Pharmaceutical registration in Indonesia is governed by BPOM (Badan Pengawas Obat dan Makanan). Every medicine must obtain an official Marketing Authorization (Nomor Izin Edar / NIE) before it can be legally imported, distributed, or sold in the country. The pharmaceutical registration process applies to new drugs, copy drugs, biological products, and biosimilars, each assessed against Indonesian national standards for safety, quality, and efficacy.

For foreign manufacturers who already hold product approvals from EMA, US FDA, TGA Australia, Health Canada, PMDA Japan, or UK MHRA, BPOM offers an accelerated evaluation pathway called Reliance Registration. Under this route, BPOM uses the Full Assessment Report from the reference country to support its review, reducing the evaluation period to 120 working days. This is the most time-efficient entry route for manufacturers already cleared in major global markets, and PRI manages the full submission process including preparation of the required Assessment Report documentation.

PRI brings together pharmaceutical registration consultant expertise and licensed in-country representation under a single engagement. Our team handles pharmaceutical registration dossiers aligned to BPOM standards, supports pharmaceutical company registration requirements for foreign entities, and manages medicine product registration renewals and variation submissions after initial approval. Whether you are entering Indonesia for the first time or expanding an existing product portfolio, we coordinate every phase of the process on your behalf.

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市場参入支援

Flexible market entry support for foreign pharmaceutical manufacturers entering the Indonesian market.

Initial Consultation

Free for a 30-minute session with our regulatory experts. We’ll review your product scope and clarify the registration pathway.

販売代理店の選択

当社は、規制および商業上の要件に準拠した適格な現地販売業者の特定と評価をお手伝いします。.

Export/Import Assistance

We manage customs clearance, import licensing, and regulatory documentation for entering the Indonesian market.

会社設立サポート

現地に拠点を設立する準備ができたら、インドネシアでの法令遵守を遵守した会社設立をお手伝いします。.

Initial Consultation

Free for a 30-minute session with our regulatory experts. We’ll review your product scope and clarify the registration pathway.

販売代理店の選択

当社は、規制および商業上の要件に準拠した適格な現地販売業者の特定と評価をお手伝いします。.

Export/Import Assistance

We manage customs clearance, import licensing, and regulatory documentation for entering the Indonesian market.

会社設立サポート

現地に拠点を設立する準備ができたら、インドネシアでの法令遵守を遵守した会社設立をお手伝いします。.

お問い合わせフォーム

弊社のチームは、お客様のビジネスニーズについてご相談に応じ、ご質問にもお答えいたします。お問い合わせフォームにご記入いただければ、1営業日以内にご返信いたします。.

お問い合わせフォーム
より迅速な対応と優先的な処理のために、会社のメールアドレスで送信してください。.

弊社に連絡するその他の方法。.

 よくある質問（FAQ）

Pharmaceutical product registration in Indonesia is the official process through which a product obtains a Marketing Authorization (Nomor Izin Edar/NIE) from BPOM, the national regulatory authority for drugs and food. Every pharmaceutical product, including prescription drugs, over-the-counter medicines, generics, and biological products, must be registered and approved before it can be legally imported, marketed, or distributed in Indonesia. The pharmaceutical registration process evaluates safety, quality, and efficacy against national standards, including Farmakope Indonesia VI.
The pharmaceutical registration process in Indonesia has two primary phases. Phase 1 is Pre-Registration (Pra-Registrasi), where BPOM assesses the application to determine the registration category, evaluation pathway, and required documentation. This stage is typically completed within 40 working days. Phase 2 is Registration and Evaluation (Registrasi), where the full product dossier is submitted alongside the government PNBP fee. For copy drugs, the standard evaluation takes approximately 150 working days. Products eligible for Reliance Registration can be evaluated within 120 working days. BPOM may extend the timeline if additional data or clarification is needed during review.
Pharmaceutical registration dossiers for Indonesia typically include administrative documents such as a Letter of Authorization, Certificate of Free Sale, and GMP certificate, alongside quality documentation aligned to Farmakope Indonesia VI, non-clinical data, clinical data, and product labeling in Bahasa Indonesia. For copy drugs, BA/BE study results are also required. Biological and biosimilar products require additional comparability data. PRI conducts a full documentation gap analysis before submission to confirm dossiers are complete and aligned to BPOM standards.
Yes. Indonesian regulations require the Marketing Authorization (NIE) to be held by a licensed local entity, but foreign manufacturers are not required to establish their own Indonesian company. PRI can serve as your Local Authorised Representative, holding product registrations on your behalf. This gives you full market access in Indonesia while keeping your product approvals independent of any distributor arrangement, and fully transferable if your commercial strategy changes.
Reliance Registration is an accelerated BPOM evaluation pathway where Indonesia uses the assessment results from a recognised reference regulatory authority to support its review decision. Products approved by EMA, US FDA, TGA Australia, Health Canada, PMDA Japan, or UK MHRA qualify for this route. Evaluation is completed within 120 working days rather than the standard timeline. To apply, the registrant must submit the Full Assessment Report from the reference country, including the List of Questions and industry responses. For foreign manufacturers already holding approvals in these markets, Reliance Registration is the most efficient route into Indonesia.
A Bioequivalence (BA/BE) study is a clinical comparison between a copy drug and the reference innovator product, conducted at an Indonesian-accredited testing facility, to confirm they are therapeutically equivalent. BA/BE studies are required for specific generic pharmaceutical products listed in BPOM’s mandatory Bioequivalence testing register under Keputusan BPOM No. 65 Tahun 2022, as well as certain other products subject to BPOM review. The study must be completed before final registration submission. PRI coordinates the full BA/BE process, from study design and site selection through results reporting and dossier integration.
A new drug (obat baru) contains an active ingredient not previously registered in Indonesia, or a registered substance with a new indication, dosage form, strength, or route of administration. Evaluation timelines for new drugs range from 100 to 300 working days depending on the registration route. A copy drug (obat copy/generik) shares the same active ingredient, dosage form, strength, and route of administration as an already-approved product. Copy drugs follow the standard 150-working-day evaluation pathway and typically require BA/BE testing to confirm clinical equivalence to the innovator product.
No. Foreign manufacturers can register and sell products in Indonesia without owning a local manufacturing facility. Pharmaceutical company registration requirements in Indonesia apply to the marketing authorization holder and the distributor, not to the physical location of the manufacturer. Products made abroad are eligible for pharmaceutical registration in Indonesia provided they meet BPOM’s GMP certification requirements and documentation standards. PRI helps foreign manufacturers navigate the full pathway regardless of where the product is manufactured.

戦略的リーダーシップ
フセイン・H・マシュア博士（医学博士）

最高執行責任者（COO）であるフセイン・H・マシュア博士（医学博士）は、インドネシアの最も複雑な規制分野における製品登録およびライセンス取得において、10年以上にわたる献身的な実務経験を有しています。彼の戦略的な監督の下、当社の業務手順と顧客サービスは、実証済みの効率的なプロセスに基づいて構築されています。コンプライアンスとオペレーションの両方に精通した専門家リーダーならではの自信と明確さを持って、お客様の旅を始めましょう。.

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