The pharmaceutical market in Indonesia is one of the largest in Southeast Asia, driven by a combination of factors such as a large population, increasing healthcare needs, and government initiatives aimed at improving healthcare access. As of recent estimates, the Indonesian pharmaceutical market is valued at around USD 10–12 billion, and growing at a CAGR of 10-12%, making it the largest in Southeast Asia. This blog explores the key regulations of pharmaceuticals in Indonesia.
Agencies Overseeing Regulation of Pharmaceuticals in Indonesia
In Indonesia, the pharmaceutical industry is regulated by the National Agency of Drug and Food Control (NADFC) also known as Badan Pengawas Obat dan Makanan (BPOM). BPOM oversees the development, manufacturing, distribution, and marketing of pharmaceuticals, ensuring the safety, efficacy, and quality of drugs in the Indonesian market.
Key NADFC / BPOM Regulations for Pharmaceuticals in Indonesia
Law No. 36 of 2009 on Health : This law serves as the foundation for regulating health services, including pharmaceuticals. It outlines the government's responsibilities to ensure public health, and it covers various aspects such as:
Ensuring the availability and affordability of safe, effective, and high-quality drugs.
Regulating the distribution and sale of pharmaceutical products.
Setting standards for drug production and marketing.
Law No. 13 of 2016 on Patents: The Patent Law governs Intellectual Property Rights (IPR) related to pharmaceuticals in Indonesia. It includes:
Regulations on patent protection for new drugs, granting exclusive rights to the patent holder for a certain period.
Compulsory licensing in certain conditions, allowing the government to permit other manufacturers to produce a patented drug in cases of public health emergencies.
Regulation No. 72 of 1998: This regulation outlines BPOM’s authority to control and monitor the distribution of pharmaceutical products and medical devices. It includes:
Criteria for drug approval, registration, and distribution.
Requirements for clinical trials and pharmacovigilance activities.
Regulation of drug recalls and corrective actions for substandard products.
Ministry of Health Regulation No. 1010 of 2008 on Drug Registration: This regulation sets the requirements for drug registration with BPOM, including:
The Common Technical Document (CTD) format for drug registration applications.
Pre-marketing requirements such as clinical trials, safety and efficacy assessments, and GMP compliance.
Procedures for submitting changes to already registered products (variation filings).
Ministry of Health Regulation No. 1799 of 2010 on Pharmaceutical Industry: This regulation governs the pharmaceutical manufacturing industry and includes provisions on:
Licensing requirements for pharmaceutical manufacturers.
GMP compliance and mandatory quality control measures.
Requirements for local production and importation of pharmaceutical products.
Rules for the export of pharmaceutical products.
BPOM Regulation No. 24 of 2017: This is one of the key regulations issued by BPOM specifically on the criteria and procedure for drug registration. It outlines:
The administrative and technical requirements for registering new and generic drugs.
The process for evaluating dossiers and product approval.
The fast-track registration process for certain categories of drugs (e.g., for critical diseases or public health emergencies).
NADFC/BPOM Requirement for Representative for Pharmaceutical Registration in Indonesia
In Indonesia, foreign pharmaceutical companies seeking to register their products must work with a local representative. The local representative will be the point of contact between NADFC/BPOM and the foreign company for all regulatory processes. The local representative must be
An Indonesian-registered legal entity.
They can be a Pharmaceutical company or Pharmaceutical wholesaler or a Local subsidiary or affiliate.
Must possess the Drug Distribution License (SIK or Izin PBF) or Production License to manufacture pharmaceutical products in Indonesia
NADFC/BPOM Classification of Pharmaceuticals in Indonesia
In Indonesia, drugs are classified into several categories based on their usage, safety, and risk levels. Below is an overview of the drug classification system:
Prescription Drugs (Obat Resep / Ethical Drugs)
Over-the-Counter Drugs (OTC) / Non-Prescription Drugs (Obat Bebas)
Limited Over-the-Counter Drugs (Obat Bebas Terbatas)
Traditional Medicines (Obat Tradisional)
Narcotic and Psychotropic Drugs
Biological Products
Orphan Drugs
Special Drugs
Generic Drugs (Obat Generik)
NADFC/BPOM Registration Pathways for Pharmaceuticals in Indonesia
Full Registration Pathway : The full registration pathway is the standard process for new chemical entities, biological products, or innovative drugs such as
New chemical entities (NCEs)
Biological products (e.g., vaccines, monoclonal antibodies)
Innovator or branded drugs
Abbreviated Registration Pathway (Generic Drugs): This pathway is for registering generic drugs, which are bioequivalent to an already registered reference drug (innovator drug) such as
Generic drugs
Fast-Track Registration Pathway : This pathway expedites the approval process for priority drugs, such as those addressing urgent public health needs, orphan drugs, or drugs for pandemics and emergencies such as
Priority medicines for public health emergencies (e.g., during pandemics).
Orphan drugs for rare diseases.
Simplified Registration Pathway (Traditional Medicines and Herbal Products): This pathway is designed for traditional medicines, herbal products, and supplements such as
Traditional medicines (e.g., Jamu).
Herbal remedies and dietary supplements.
Expedited Registration Pathway (COVID-19 and Emergency Use): During public health crises, such as the COVID-19 pandemic, BPOM has implemented an expedited review process for vaccines, treatments, and diagnostics. This pathway allows rapid approval of drugs that are urgently needed. Applicable for:
COVID-19 vaccines.
Antiviral drugs or treatments for pandemic diseases.
Registration Pathway for Imported Drugs: The registration process for imported drugs generally follows one of the pathways mentioned above, depending on the drug type.
NADFC/BPOM Documentation and CTD Requirements for Pharmaceuticals in Indonesia
Dossier Submission Requirements for Different Drug Types
New Drugs (Innovative Drugs): Full CTD dossier including detailed clinical trial data
Stability Data: Long-term, accelerated, and in-use stability studies are needed.
Clinical Data: Includes local clinical trials if necessary, or foreign clinical trial data with relevance to the Indonesian population.
Generic Drugs: The dossier submission follows the abbreviated format of the CTD.
Bioequivalence Study: Demonstrating therapeutic equivalence to the reference innovator drug (required under Module 5).
Module 4: Non-clinical studies may not be required for generics.
Stability Data: Stability testing for the generic formulation.
Biological Products: Products such as vaccines, monoclonal antibodies, blood products require more extensive data due to the complexity of their production.
Module 3 : (Quality) is significantly expanded for biologics to cover the detailed production process of biological materials.
Immunogenicity Studies: Specific immunogenicity testing is required to evaluate safety.
Traditional Medicines and Herbal Products: Traditional and herbal products follow a simplified registration process.
Module 3 is the most critical, focusing on quality and safety of the ingredients, manufacturing processes, and GMP compliance.
Clinical and non-clinical data may not be required, especially for products with a well-documented history of safe use.
Additional Dossier Requirements for Imported Drugs
For imported drugs, additional documents must be submitted along with the CTD dossier:
Certificate of Pharmaceutical Product (CPP) from the country of origin.
Good Manufacturing Practice (GMP) Certificate of the manufacturing facility.
Import License: Issued by BPOM or the relevant authority.
Letter of Authorisation for Local Representative
Dossier Submission Format for Pharmaceuticals in Indonesia
Electronic Submission: BPOM encourages electronic submissions to streamline the review process.
Hard Copy (if required): Some submissions may still require hard copies, particularly for traditional medicines or smaller companies.
Language: The dossier must be submitted in Bahasa Indonesia or accompanied by a certified translation.
NADFC/BPOM Labeling Requirements for Pharmaceuticals in Indonesia
All information on the label must be written in Bahasa Indonesia. For imported drugs, a certified translation must be provided. The following information is mandatory for inclusion on all drug labels:
Product Name
Composition
Dosage Form and Strength
Indications and Uses
Dosage and Administration
Contraindications
Warnings and Precautions
Adverse Reactions
Storage Conditions
Expiry Date and Lot Number
Registration Number
Manufacturer Information
Authorization by BPOM
Special Symbols and Identification
NADFC/BPOM Classification Labels for Pharmaceuticals in Indonesia
Green Circle: Over-the-counter (OTC) or free drugs (Obat Bebas).
Blue Circle: Limited over-the-counter drugs (Obat Bebas Terbatas) with usage restrictions.
Red Circle with "K": Prescription drugs (Obat Keras).
Red Circle with "N": Narcotic drugs (Obat Narkotika).
Special Symbols: Additional labeling for psychotropic drugs, traditional medicines, biological products, and generic drugs.
NADFC/BPOM Registration Fees for Pharmaceuticals in Indonesia
The NAFDC fees vary depending on the drug category and the pathway. Generally, the fees for imported drugs are comparable to those for locally manufactured products.
Registration category | Registration Fees (IDR/USD) |
New Drug | 10 million to 20 million (USD 650–1,300) |
Generic Drug | 8 million to 15 million (USD 520–1,000) |
Traditional Medicines and Herbal Products | 2 million to 5 million (USD 130–325) |
Biologics and Biosimilars | 15 million to 30 million (USD 975–1,950). |
Fast-Track or Expedited Registration | 10 million to 25 million (USD 650–1,625) |
Minor Variantions / Amendments | 1 million to 3 million (USD 65–195) |
Major Variantions / Amendments | 5 million to 10 million (USD 325–650) |
NADFC/BPOM Timelines for the approval of Pharmaceuticals in Indonesia
Registration Pathway | Description | Timeline |
Full Registration | For new chemical entities, biologics, or innovative drugs. | Up to 300 WD |
Abbreviated Registration | For generic drugs requiring bioequivalence data. | Up to 150 WD |
Fast-Track Registration | For priority drugs (orphan, pandemic, public health). | Less than 150 WD |
Simplified Registration | For traditional medicines and herbal products. | Up to 100 WD |
Expedited (Emergency Use) | For urgent products (e.g., COVID-19 vaccines, treatments). | <100 WD |
Imported Drugs Registration | For foreign products with a local representative. | Varies |
WD: Working days
Validity of the NADFC/BPOM Approvals for Pharmaceuticals in Indonesia
The marketing authorization of a pharmaceutical approved by NAFDC /BPOM is valid for five years from the date of issuance.
Renewal of Pharmaceuticals Marketing Authorizations in Indonesia
Before the five-year period ends, companies must submit a renewal application to BPOM to extend the marketing authorization.
NADFC/BPOM Post Marketing Surveillance (PMS) Requirements for Pharmaceuticals in Indonesia
Post Marketing Surveillance is an essential part of the regulatory framework to ensure the continuous monitoring of drug safety and efficacy after a product has been approved and marketed.
Adverse Drug Reaction (ADR) Reporting : All pharmaceutical companies are required to have a pharmacovigilance system in place to collect, assess, and report adverse drug reactions (ADRs) from healthcare professionals, patients, or consumers.
Periodic Safety Update Reports (PSUR) : Pharmaceutical companies must submit PSURs on a regular basis, typically every 6 months for the first two years after the drug is marketed, and then annually thereafter.
Risk Management Plan (RMP): BPOM may require the submission of a Risk Management Plan (RMP) as part of PMS. The RMP outlines strategies for minimizing identified risks associated with the drug and includes:
Risk minimization measures (e.g., additional labeling warnings, restricted distribution).
Ongoing monitoring and reporting plans.
Risk communication strategies for healthcare providers and patients.
Product Quality Monitoring
Routine Inspections: BPOM conducts regular inspections of manufacturing facilities, distribution centers, and pharmacies to ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Pharmacy Practices (GPP).
Sampling and Testing: BPOM conducts random sampling and testing of pharmaceutical products available on the market to verify the consistency of product quality, purity, and potency.
BPOM regulations ensure that the pharmaceutical industry in Indonesia operates in line with international standards, while protecting public health and ensuring access to high-quality, affordable medicines. Compliance with these laws is crucial for companies operating in the Indonesian pharmaceutical market.
Navigating through the complex web of pharmaceutical regulations requires professional guidance and in depth understanding of the regulations. To ensure you get the best consultation services by a team of experts, contact info@artixio.com.
References: