Indonesia Regulatory Watch: A Primer on Drug Registration in Indonesia – August 2025

BPOM is Indonesia’s central authority for regulating pharmaceuticals, traditional herbal medicines, cosmetics, and food products. BPOM is responsible for evaluating, approving, and monitoring all drug products distributed in the country.

Key functions include:

• Product registration and evaluation

• Post-market surveillance and pharmacovigilance

• Good Manufacturing Practice (GMP) inspections and licensing

• Public education and counterfeit prevention

All pharmaceutical products, whether imported or locally manufactured, must be registered with BPOM before commercialization. This includes ethical drugs, Over the counter (OTC) medicines, traditional and herbal products, and biologicals.

• Step 1: Pre-Submission Preparation
  • Product classification: Determine whether the product is a new drug, generic, biologic, or traditional medicine.
  • Local representative: Foreign companies must appoint a local Indonesian agent or affiliate.
  • Document preparation: Includes administrative documents (e.g., Certificate of Pharmaceutical Product/CPP, GMP certificate), quality dossiers (e.g., Drug Master File), and clinical/non-clinical data. CPP refers to a certificate that approves the marketing of a pharmaceutical product, and GMP refers to a certificate that confirms compliance with manufacturing and quality control standards.

• Step 2: Online Submission via BPOM Portal
  • Applications are submitted through BPOM e-Registration system.: e-Registration
  • Applicants choose one of three review pathways:
    • 100-days: For orphan drugs or urgent public health needs
    • 120-days: For drugs approved in reference countries (e.g., US, EU, Japan)
    • 300-days: Standard review for new drugs or major variations registration with new indications/posology
• Step 3: Evaluation Process
  • Administrative screening: Ensures completeness and compliance.
  • Technical review: Assesses safety, efficacy, and quality.
  • GMP inspection: Required if the manufacturing site is not previously certified by BPOM.
• Step 4: Clarifications and Supplementation
  • BPOM may request additional data or clarifications. Applicants typically have 120 days to respond.
• Step 5: Marketing Authorization
  • Upon approval, BPOM issues a Nomor Izin Edar (NIE) – the official marketing authorization number, valid for 5 years and renewable upon re-evaluation.
• Step 6: Post-Market Surveillance
  • Includes pharmacovigilance, sampling, advertising monitoring, and recalls if necessary.

In 2025, BPOM launched a Regulatory Development Program (Decision No. 278/2025) to revise and streamline regulations across pharmaceuticals, supplements, and cosmetics. While the initial focus has been on food and health supplements, the roadmap signals a broader push toward:

• Digitalization of regulatory processes
• Greater transparency and efficiency
• Alignment with international standards (e.g., The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), ASEAN guidelines)

Companies entering the Indonesian market should be aware of several regulatory nuances:

• Language requirements: Most documents must be submitted in Bahasa Indonesia.
• Local clinical data: Required for certain product categories, especially new chemical entities.
• Product classification: Misclassification can delay approval; early consultation with BPOM is recommended.

Strategic tip: Collaborating with experienced local partners can significantly reduce regulatory risk and accelerate market entry.

We hope this primer provides a useful starting point for navigating Indonesia’s pharmaceutical regulatory landscape. In our next issue, we will explore the structure and functions of BPOM in greater detail, including recent digital initiatives and organizational reforms.

If you are planning registration in Indonesia or considering ASEAN expansion, we are ready to support you with proven strategies tailored to BPOM’s current direction.