Regulatory Service Provider for Biologics in Indonesia
Your trusted, End-to-End Regulatory Service provider for Biologics in Indonesia
Artixio is a latory services company, offering complete support throughout the pharmaceutical commercialization journey. With extensive experience in strategic product registration, our team helps clients reduce time to market and maximize commercial potential. For Indonesia, Artixio provides end-to-end regulatory support for the registration of biological products with the National Agency of Drug and Food Control (BPOM). Our team brings deep expertise in biologics commercialization and lifecycle management, ensuring a streamlined and efficient market entry strategy according to the regional requirements.
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.
The application dossier for a biological product registration in Indonesia is submitted according to the format of ASEAN CTD (ACTD) which is as follows,
| 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
I. Registration at NADFC Online System
Applicant must register at the website: e-Registration of Biological Drugs and Products
II. Pre-registration Phase
Application submission and evaluation
III. Registration Phase
Submission of Registration form
IV. Evaluation Phase
V. Additional data requests (if needed)
VI. Decision on Approval or Rejection of Marketing Authorization
VII. Appeal and Re-submission
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?
The fees required for registration of a biological product in Indonesia is 15 million to 30 million IDR (USD 975-1950).
What is the standard timeline for approval of a biologic product in Indonesia?
Registration of a biological product in Indonesia takes up to 300 working days.
What is the validity period of a marketing authorization Indonesia?
The marketing authorization in Indonesia is valis for 5 years except for license and contract manufacturing product and it can be extended through renewal registration mechanism.
How do Artixio’s services support regulatory operations?
Artixio provides scalable operations services to support regulatory operations including:
- 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
India
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Mexico
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
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