Indonesia
Medicinal Product
Our Experiences
Experienced more than 13 years in handling a wide range of product types, including New Drug Applications (NDA), biologics, generics, cosmetics, health supplements, traditional medicine, and medical devices.
>10 NDA submissions in Indonesia, including NCE, biologics, generics, cosmetics, health supplements, traditional medicine.
Handled Marketing Authorization Transfers, regulatory support for transfer inventory and grace period between Product Owner and Distributor.
Authorization of Importers.
Provided comprehensive life cycle management including variations, pharmacovigilance services such as PSUR submission, ICSR, product defect handling, etc.
Delivered regulatory intelligence reports, dossier gap analysis to facilitate successful market entry.
Managed the regulatory responsibilities for the Product Owner role, ensuring compliance with relevant laws and standards to meet regulatory requirements throughout the product lifecycle.
In Pharmacovigilance Audits and Inspections, prepare for and participate in internal audits and inspections by CAs of the national pharmacovigilance system in collaboration with concerned departments.
In Pharmacovigilance activities, responsible for a comprehensive array of pharmacovigilance activities, ensuring the safety and compliance of the products, and organise the local system of pharmacovigilance, ensuring responsibility and liability for marketed products (therapeutic products, medical devices and cosmetic products).
Our Establishment
As of now, we have not yet established the necessary infrastructure or processes to assume the responsibilities of a Pharmaceutical Marketing Authorization Holder (MAH). This involves meeting a range of regulatory, legal, and operational requirements, including the establishment of a pharmaceutical manufacturing facility.
However, we do have services that play an important role in product sustainability:
1. Regulatory Affairs: We are providing in managing and navigating the regulatory processes involved in bringing a product (such as a pharmaceutical, medical device, or biologic) to market. This support is essential for ensuring that a product complies with the laws, regulations, and standards of the country or region where it will be sold. Regulatory affairs professionals typically oversee all stages of the product lifecycle, from development to post-market activities, to ensure regulatory compliance.
2. Pharmacovigilance Setup: We are establishing the necessary pharmacovigilance infrastructure for safety monitoring, adverse event reporting, and risk management.
3. Compliance Framework: We are working on ensuring compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and other relevant quality standards.
Overview of Pharmaceutical Product Registration in Indonesia
Pharmaceutical product registration in Indonesia is governed by the National Agency of Drug and Food Control / NADFC (BPOM, Badan Pengawas Obat dan Makanan), which is responsible for ensuring the safety, efficacy, and quality of pharmaceutical products in the country. The process for registering pharmaceutical products in Indonesia involves several key steps, as outlined below:
01
Pre-Submission Preparation
02
Submission of Application to BPOM
• Dossier Preparation: Prepare a complete registration dossier that includes: Product information (e.g., composition, strength, dosage form). Clinical trial data (if applicable) to demonstrate safety and efficacy. Manufacturing site details, GMP compliance certificates, and quality control measures.
• Submission: Submit the registration application through BPOM's online system, e-Registration. This includes submitting all necessary documentation and paying the required fees.
03
Evaluation Process by BPOM
04
Inspection (if necessary)
05
Approval and Issuance of Marketing Authorization
06
Post Approval Changes
07
Post-Marketing Surveillance and Reporting (Pharmacovigilance, Renewal of Registration) The pharmaceutical product registration process in Indonesia is thorough and involves compliance with regulatory standards to ensure the safety, quality, and efficacy of drugs. Companies planning to enter the Indonesian market must carefully follow BPOM’s procedures, submit comprehensive documentation, and be prepared for potential inspections.
Medicinal Product Classification in Indonesia
Medicinal products are classified into the following categories:
Chemical Drug / New Chemical Entity (NCE)
Biologics
Biosimilars
Other Preparations Containing Drugs with Special Technology
(such as transdermal patches, implants, and beads)
Health and Food Supplements
Generic Drugs
Traditional Medicines
Registration Requirements for Pharmaceutical Products in Indonesia
International
• WHO, ICH, EMA, US-FDA
Regional
• ASEAN Guidelines for Stability Process Validation Variation
• ASEAN Common Technical Dossier (ACTD)
Local
• Regulation of NADFC / BPOM
• Checklist(s) issued by NADFC / BPOM
• Manual Book / User Manual of registration online system
Key Registration Requirements for Pharmaceutical Products in Indonesia:
01
• Chemical Drug / New Chemical Entity (NCE)
• Biologics
• Biosimilars
• Other preparations containing drugs with special technology, such as transdermal patches, implants, and beads
• Generics Drug
• Health and Food Supplements
• Traditional Medicines
Product Classification
02
Marketing Authorization Holder: Marketing Authorization Holder who is the Applicant and responsible for ensuring all regulatory requirements are met and for interacting with BPOM on behalf of the manufacturer. Applicant means Pharmaceutical Industry that has obtained licensing in Pharmaceutical Industry in accordance with the provisions of legislation. Foreign manufacturers must appoint a local Pharmaceutical Industry in Indonesia. This entity will act as the liaison between BPOM and the foreign manufacturer for the registration process.
Marketing Authorization Holder
03
A comprehensive set of documents must be submitted to BPOM to support the registration application. These include:
• Certificate of Pharmaceutical Product (CPP) or Free Sale Certificate (FSC): Issued by the health authority of the country of origin to certify that the product is legally sold and complies with the regulations of that country.
• GMP Certificate: Proof that the manufacturing site adheres to Good Manufacturing Practices (GMP). BPOM may inspect foreign facilities to verify compliance with local GMP requirements.
• Product Information: This includes: Composition: A detailed list of active ingredients and excipients. Manufacturing Process: Information on how the product is manufactured. Stability Data: Data showing the product's stability under specific conditions over time. Clinical Data: If applicable, clinical trial data to demonstrate the safety and efficacy of the product.
• Product Labeling: The product labels must be in the Indonesian language and comply with BPOM’s guidelines. This includes:
Name of the product Composition (active ingredients and strength) Dosage form (e.g., tablet, injection) Directions for use Expiry date Manufacturer details Warnings and contraindications
• Safety and Efficacy Data: Clinical trials, post-market surveillance, or other scientific evidence to demonstrate that the product is safe and effective for its intended use.
• Marketing Authorization: For pharmaceutical products already authorized in other countries, proof of registration and marketing authorization from the country of origin may be required.
Required Documentation for Registration
05
Evaluation Process by BPOM
BPOM evaluates the submitted dossier in several key areas:
• Quality Review: BPOM assesses the product’s quality, including manufacturing processes and stability data.
• Safety and Efficacy Review: BPOM reviews clinical trial data, scientific literature, and other evidence to assess the safety and efficacy of the product.
• Labeling Compliance: The labeling must meet the specific requirements set by BPOM, including language, health warnings, and dosage instructions.
• GMP Clearanse for Import product and / or Inspection: BPOM may conduct inspections of the manufacturing facility (local or foreign) to ensure compliance with GMP standards.
06
Approval and Issuance of Marketing Authorization
• Once BPOM is satisfied with the application and the product complies with all regulatory requirements, it issues a Marketing Authorization (NRA number) allowing the product to be sold in Indonesia.
• The product is listed in BPOM’s approved product database, and the marketing authorization is valid for a specific period (usually 5 years).
07
Post-Market Surveillance
After registration and approval, the following requirements apply:
• Pharmacovigilance: Ongoing monitoring of the product’s safety. Pharmaceutical companies are required to report any adverse events or side effects to BPOM.
• Periodic Reporting: Companies must submit periodic safety update reports (PSUR) and renew product registrations every 5 years.
• Market Compliance: Products must continue to comply with Indonesian regulations regarding manufacturing, labeling, and distribution.
08
Special Requirements for Specific Products
• Biologics and Biosimilars: These require additional clinical trial data, and BPOM may impose more stringent requirements for approval.
• Traditional Medicine: These have a different registration pathway, often with less rigorous clinical trial requirements but still require proof of safety and efficacy.
• Importers: Pharmaceutical products imported into Indonesia must comply with BPOM’s importation requirements, including customs clearance and documentation review.
04
Regulatory Process and Submission
• e-Registration: BPOM requires all registration applications to be submitted through its e-Registration system, an online platform designed to streamline the registration process.
• Initial Evaluation: BPOM reviews the submitted documentation to ensure that all required information is complete and compliant with regulatory standards.
• Fee Payment: Registration fees must be paid at the time of submission. The fees vary depending on the type of product and its complexity.
09
Labeling and Packaging Requirements
• All pharmaceutical products must comply with local regulations for labeling and packaging. This includes providing information in Bahasa Indonesia and meeting BPOM’s specifications for font size, language, and health warnings.
• Labels must include product name, composition, manufacturer, dosage instructions, batch number, expiry date, and other necessary health information.
10
Regulatory Fees
Fees for product registration are determined by BPOM and may depend on the type of product (e.g., pharmaceutical, biologic, or medical device). These fees cover the cost of evaluation, inspections, and administrative processing.
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Timeline and Fee for Pharmaceutical Products Registration in Indonesia
How can we help?
• Pre-market strategic consulting and feasibility assessment
• Regulatory intelligence and market entry strategy
• Product classification and regulatory gap analysis
• GMP compliance auditing and advisory
• Dossier preparation and submission handling
• Local entity support
• Life cycle management such as post-market surveillance and pharmacovigilance support
• Pre-submission consultation activity with health agency
• Import license application
• Change of Product Registration Holder
• Ad-hoc regulatory affairs consultation
• Pharmacovigilance support services
