Artixio

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,
PartDocuments
Part IAdministrative data
Part IIQuality
Part IIINon-Clinical Documents
Part IVQuality Documents

Following are the registration categories for a product in Indonesia

I. New Registration

II. Variation Registrations

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

Artixio provides following services for biological products in Indonesia

Why Artixio?

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).
Registration of a biological product in Indonesia takes up to 300 working days.
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.
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
Vietnam
Mexico​
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines

Industries we serve

Pharmaceuticals

Cosmetics

Nutrition

Medtech

Biologics

Veterinary

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