Biologics Product Registration & Regulatory Services in Indonesia
Your trusted, End-to-End Regulatory Service provider for Biologics in Indonesia. Our team handles biologics product registration and regulatory documentation in Indonesia. With experience in BPOM processes, we help ensure your biologic product meets national standards.
Biologics Approval & Product Registration with BPOM Indonesia
Regulatory Body of Indonesia
The regulatory authority of Indonesia is the National Agency of Drug and Food Control (NADFC), known in Indonesian as Badan Pengawas Obat dan Makanan (Badan POM or BPOM). This agency is responsible for safeguarding public health by overseeing and regulating prescription and over-the-counter medicines, dietary supplements, traditional medicines, cosmetics, and food safety.
Indonesia Biologics Product Regulatory Process
Part | Documents |
---|---|
Part I | Administrative data |
Part II | Quality |
Part III | Non-Clinical Documents |
Part IV | Quality Documents |
Following are the registration categories for a product in Indonesia
I. New Registration
- New drugs or biological products (including biosimilars) (Category 1)
- Generic drugs (Category 2)
- Other dosage form with new technology (Category 3)
II. Variation Registrations
- Major Variation (Category 4)
- Minor Variation (Category 5)
- Notification (Category 6)
III. Renewal (Category 7)
Steps for registration of a biologic product in Indonesia
V. Additional data requests (if needed)
VI. Decision on Approval or Rejection of Marketing Authorization
VII. Appeal and Re-submission
Artixio provides following services for biological products in Indonesia
- Efficient Regulatory Strategy for registration of the product with NADFC (BPOM)
- Advisory, scientific writing and execution support
- Regional support in applicable language
- Services to support regulatory functions
- Labeling and artwork
- Easy market access strategies for the products
- Strategies for Product branding and Launch
Why Artixio?
- 5000+ Licenses approved and maintained
- End-to-End services from product conceptualization to post marketing maintenance
- Well networked with Health Authorities
- Regional Expertise
- ISO 9001:2015, Quality Driven Services Platform
- Client focused Services
FAQs
What is the fees for registration of a biological product in Indonesia?
What is the standard timeline for approval of a biologic product in Indonesia?
What is the validity period of a marketing authorization Indonesia?
How do Artixio’s services support regulatory operations?
- Publishing Operations
- Change Management and Stakeholders Coordination
- Project Management
- Regulatory Information Management
- Regulatory Document Management and Coordination
- Bookmarking and Hyperlinking
- Document and Submission Level Publishing
- Product Lifecycle Management
- End to End eCTD Publishing
Regulatory Expertise Across Multiple Countries












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