Kontak

Pharmaceutical Registration 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.

Why Pharmaceutical Registration in Indonesia Is Particularly Challenging for Foreign Manufacturers

Most delays and rejections in pharmaceutical registration come from the same structural challenges. Understanding them early makes a significant difference to timeline and cost.

01

A local entity is mandatory, but most foreign manufacturers do not have one

Indonesian regulations require every registered pharmaceutical product to be held under a licensed local entity. Foreign manufacturers without an Indonesian company must either establish a local entity or appoint an authorised local representative before registration can proceed. Without this structure in place, no dossier, however complete, will be accepted by BPOM.

02

BA/BE testing requirements add significant time and cost to the process

Generic pharmaceutical products in Indonesia typically require a Bioequivalence study at an Indonesian-accredited facility. The study can cost up to IDR 300,000,000 per product and adds months to the registration timeline. Many foreign manufacturers are unaware of this requirement until they are already mid-process, which creates costly delays.

03

BPOM dossier standards differ from FDA, EMA, and other reference markets

BPOM evaluates pharmaceutical registration dossiers against Indonesian-specific standards, including Farmakope Indonesia VI and Bahasa Indonesia labeling requirements. Documents prepared to FDA, EU CTD, or other international formats require significant adaptation before they meet BPOM submission standards. Gaps in the dossier are the most common cause of clarification requests and extended timelines.

Dukungan Kepatuhan Tanpa Batas

Layanan Ujung ke Ujung

Kami mengelola seluruh jalur regulasi mulai dari perizinan hingga registrasi produk.

Keahlian Regulasi

Tim kami menggabungkan pengetahuan dan pengalaman mendalam untuk menavigasi lanskap regulasi yang kompleks.

Kecepatan dan Efisiensi

Strategi kami yang telah terbukti mempercepat proses pendaftaran dan persetujuan untuk pasar Indonesia.

Dukungan yang Disesuaikan

Memberikan panduan yang dipersonalisasi dan dukungan khusus untuk memastikan perjalanan yang lancar dan tanpa kekhawatiran.

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 dossier 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.

Pesan Konsultasi

Dukungan untuk Memasuki Pasar

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.

Pemilihan Distributor

Kami membantu mengidentifikasi dan menilai distributor lokal yang memenuhi syarat dan sesuai dengan persyaratan regulasi dan komersial.

Export/Import Assistance

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

Dukungan Pendaftaran Perusahaan

Saat Anda siap untuk membangun kehadiran lokal, kami akan membantu pembentukan perusahaan yang sesuai dengan peraturan di Indonesia.

Initial Consultation

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

Pemilihan Distributor

Kami membantu mengidentifikasi dan menilai distributor lokal yang memenuhi syarat dan sesuai dengan persyaratan regulasi dan komersial.

Export/Import Assistance

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

Dukungan Pendaftaran Perusahaan

Saat Anda siap untuk membangun kehadiran lokal, kami akan membantu pembentukan perusahaan yang sesuai dengan peraturan di Indonesia.

Formulir Permintaan

Tim kami siap mendiskusikan kebutuhan bisnis Anda dan menjawab pertanyaan apa pun yang mungkin Anda miliki. Isi formulir pertanyaan kami, dan kami akan merespons dalam satu hari kerja.

Formulir Kontak
Kirimkan dengan email perusahaan Anda untuk respons yang lebih cepat dan penanganan prioritas.

Cara lain untuk menghubungi kami.

 Pertanyaan yang Sering Diajukan (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.

Kepemimpinan Strategis dengan
Dr. Hussein H. Mashhour, MD

Sebagai Chief Operating Officer (COO) kami, Dr. Hussein H. Mashhour, MD, membawa lebih dari satu dekade pengalaman langsung yang berdedikasi dalam pendaftaran dan perizinan produk di berbagai sektor regulasi paling kompleks di Indonesia. Pengawasan strategisnya memastikan bahwa prosedur operasional dan layanan klien kami dibangun di atas proses yang terbukti efisien. Mulailah perjalanan Anda dengan keyakinan dan kejelasan yang hanya dapat diberikan oleh seorang pemimpin ahli di bidang kepatuhan dan operasional.

Pesan konsultasi gratis
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