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Strategic Regulatory Partner in Indonesia for pharmaceuticals
Artixio, your trusted partner for end-to-end regulatory services from development to life cycle management.
Pharmaceuticals
Regulatory Affairs
Product Registration
IND (Investigational New Drug)
NDA (New Drug Application)
Technical Writing
Regulatory Strategy
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Market Access
Regulatory Operations
The Indonesian pharmaceutical market is experiencing growth with a 4.77% annual growth rate and a large pharmaceutical market in South-East Asian nations. Our regulatory experts have excellence in the regional regulatory framework of pharmaceuticals in Indonesia, regulated by National Agency of Drug and Food Control (NADFC) also called as Badan Pengawas Obat dan Makanan (BPOM). Artxio’s team offers comprehensive support for market approval, regulatory insights throughout product development and accelerated successful approval launching.
Key regulation in Indonesia for Pharmaceutical
In Indonesia pharmaceutical is regulated under the BPOM Regulation No. 1020/MENKES/PER/XII/2008 for registration process requirements. Indonesia is member of ASEAN (Association South-East Asian Nations) registration application must submit in ACTD format through Online Single Submission (OSS).
Classification of registration applications
- Category 1: New Drug Products
- Category 2: Generic products
Registration Procedure
Registration of pharmaceutical product consist of two stages-
Pre-registration Stage –
Pre-registration stage includes establishing evaluation pathway and registration fee, screening of documents.
Pre-registration evaluation will be done within 40 working days.
Registration Stage –
After evaluation and approval of pre-registration stage application further review for quality, safety, efficacy, and labeling information in registration phase. Timeline depends on approval pathway.
Registration Approval Pathways
Full Application pathways
- For new drug products that have not been approved previously in any countries.
- Timeline- 300 working days
Abridged evaluation pathways
- Applies to drug products that have been approved in other reference countries.
- Timeline- 150 working days
Special approval pathways
- For life saving drugs, orphan drug and drug product for emergency condition
- Timeline- 100 working days
Artixio’s regulatory Services in Indonesia for Pharmaceuticals
- Regulatory Intelligence
- Pre-submission facilities
- Gap assessment
- Dossier preparation
- Registration facility
- Market launch
- Labelling and Artwork
- Product line extension
- Post approval lifecycle management
- ADR reporting services
Why Artixio?
Navigating regional pharmaceutical regulations with confident and clear way
Result-driven approvals and ongoing product lifecycle maintenance for 200+ products.
Industry Recognized (CPHI Pharma Awards 2024) Tech-Enabled, Regulatory Intelligence driven Services
Inhouse Regulatory Experts with 15-30+ Years of Experience
End to End Support from Product Conceptualization to Launch and Post Market Support
Wide Therapeutic Areas, Formulation and Route of Administration Experience
ISO 9001:2015, Quality Driven Services Platform
Flexible Business Models – Project Based; Long Term FTE based
Customer Focused, Nimble Team
KPI based, continual process excellence
FAQs
How to manage different post approval changes in Indonesia
As per BPOM regulation post approval changes categorise as follows-
| Sr. No. | Variation Category | Description | Timeline |
|---|---|---|---|
| 1 | Major Variation (VaMa) | Changes with significant impact on efficacy, safety, or quality. Prior approval required. | Varies (100-300) WD |
| 2 | Minor Variation (VaMi-B) | Minimal effects on quality of product that requires prior approval. | 40 WD |
| 3 | Minor Variation (VaMi-A) | No effects on quality, safety of product. No prior approval requirement, need to submit notification. | — |
Can foreign manufacturer launch pharmaceutical product in Indonesia market?
As per BPOM, only local pharmaceutical company can import the pharmaceutical drug product in Indonesia, to launch the drug product foreign company requires pharmaceutical license of local company.
What is the validity of pharmaceutical license in Indonesia
Pharmaceutical license is valid for 5 yeas from the date
of Marketing authorization issued by BPOM.
of Marketing authorization issued by BPOM.
Which are the reference countries BPOM accepts data for Abridged evaluation?
US-FDA, EU-EMA, Japan-PMDA, Canada-Health Canada, Australia- TGA and other ASEAN countries accepted as reference countries.
Regulatory Expertise Across
Multiple Countries
India
Vietnam
Mexico
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines
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