Pharmaceutical Regulatory Services in Singapore
From Strategy to Registration and Post Market, Comprehensive Solutions for Pharmaceuticals in Singapore
Pharmaceuticals
Regulatory Affairs
Product Registration
IND (Investigational New Drug)
NDA (New Drug Application)
Technical Writing
Regulatory Strategy
Digital Marketing
Market Access
Regulatory Operations
With a seasoned team of regulatory affairs, market access and pharmacovigilance professionals based in Singapore, Artixio is helping global top 10 pharma and several mid and small biotech companies with their commercial and regulatory go to market needs in the country. A pharmaceutical industry woth US$7.4B, Singapore is among highly regulated markets in Asia and prominent business location for global manufacturers. Artixio, with its experience is your trusted partner to help you navigate the local regulations and successful commercialization and compliance.
Regulatory Authorities in Singapore
Health Sciences Authority (HSA) is the governing body that regulates the pharmaceutical products in Singapore. Singapore also accepts ASEAN Common Technical Document (ACTD) and eCTDformat with additional country specific requirements. Detailed guidelines and regulations are provided on the HSA website. Manufacturers can apply for consultation and carry out online transactions at the Pharmaceutical Regulatory Information Management System (PRISM).
Applications Types in Singapore for Pharmaceuticals
| Application Code | Type | Description |
|---|---|---|
| NDA 1 | New Drug Application | A New Chemical Entity’s first strength that is not registered in Singapore currently. |
| NDA 2 | New Drug Application | New combinations, dosage forms, presentations, formulations, routes of administration, indications, dosages, or patient populations not under NDA 1, NDA 3, or GDA. |
| NDA 3 | New Drug Application | Subsequent strengths of a product registered under NDA 1 or NDA 2. |
| GDA 1 | Generic Drug Application | First strength of a generic chemical drug. |
| GDA 2 | Generic Drug Application | Subsequent strengths not registered under GDA 1 with the same product name and dosage form as GDA 1. |
Artixio’s Pharmaceutical Regulatory Services in Singapore
Pre-Registration
- Local Responsible Person / Representative
- Regulatory Intelligence & Strategy
- Dossier Gap Analysis
- HA Meetings and Consultation with HSA
- Import Strategy
Registration
- Local Responsible Person / Representative
- Dossier Preparation
- Submission of Application
- Medical Writing
- Clinical Trials / BE Studies Support
- Response to HSA Queries
- Import License
- Marketing Authorization License (MA)
- Labeling and Artwork
Post Market
- Local Responsible Person / Representative
- Post Approval Lifecycle Maintenance
- Renewals
- Advertisement & Promotional Material Review
- Variations
- Line Extensions
- Import Assistance
- Tender Support
- Ongoing Regulatory Intelligence & Monitoring
Why Artixio As your Regulatory Consultant In Singapore?
Support across NDA, ANDA, and variation filingsnized (CPHI Pharma Awards 2024) Tech-Enabled, Regulatory Intelligence driven Services
You get direct access to regulatory professionals, not just coordinators
Experience with eCTD submissions via PRISM
Trusted by regional teams managing multi-country filings
ISO 9001:2015, Quality Driven Services Platform
Fast support for post-approval changes and renewals
Clear guidance on local labeling and PI requirements
Well-versed in HSA regulatory pathways
FAQS
1. What are applicable pathways for registration of pharmaceutical products in Singapore?
Based on the product type, its status and available data, following evaluation pathways are applicable in Singapore from HSA.
- Full Evaluation Route
- Abridged Evaluation
- Verification
- Reliance Route based on approvals from reference countries
2. What are the reference countries accepted by HSA in Singapore?
US FDA, EMA, Health Canada, TGA Australia, UK MHRA, Swissmedic are some acceptable reference countries. Consultation with HSA is recommended based on product status.
3. What is the validity period of registration license in Singapore?
The approval is valid for 5 years from the date of approval and need to be renewed accordingly. Any variations must be submitted under Minor or Major applications.
4. Do you provide advice and guidance on Regulatory Requirements in Singapore before and after registration? Such as ongoing insights on regulations and impact on products?
Yes, Artixio provide regulatory intelligence, insights and strategic decision support throughout the product lifecycle from development to approval and post approval. The advice includes regulatory strategy and pathway based on product, dossier gap analysis against HSA requirements. QuriousRI, a regulatory intelligence platform from Artixio monitors updates from health authority on continuous basis evaluating their impact on different pharmaceutical products.
5. How can foreign manufacturer register pharmaceutical drugs in Singapore?
Foreign manufacturers require Singapore citizen/business entity with valid pharmacy license to represent to HSA. Applications for consultation or submission can be prepared and submitted to HSA through the representatives.
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