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Regulatory Service Provider for Biologics in Singapore
A trusted End-to-End Service Provider for Biologics in Singapore
Artixio provides complete end-to-end support for registration of a biological product with Health Sciences Authority (HSA), a regulatory authority of Singapore. Our consultants in Singapore are highly experienced in product commercialization and lifecycle management. Our regulatory strategy helps clients to maximize commercial potential by reducing the time to market entry.
Regulatory overview of Singapore
HSA considers Therapeutic Products, A product which contain chemical or biologic substances as active ingredients and exert their effect through pharmacological, chemical or other physiological means.
Singapore regulates therapeutic products under the Health Products Act (HPA) and its regulations, including the Health Products (Therapeutic Products) Regulations of 2016.
Applicant can submit the Therapeutic Product application through following 2 types
- New Drug Application (NDA-1, NDA-2, NDA-3)
- Generic Drug Application (GDA-1, GDA-2)
Where, NDA is applicable for a therapeutic product containing new chemical and biological entities and GDA is applicable for a therapeutic product containing one or more chemical entities and it is having the same qualitative and quantitative composition of active ingredients as the Singapore Reference Product.
Registration of a Therapeutic product in Singapore takes place through following steps
The application dossier to be submitted is organized either in the ICH-CTD or the ASEAN-CTD format. The organization of these dossier formats is as follows
| Documents | Location in ICH CTD | Location in ASEAN CTD |
|---|---|---|
| Administrative documents | Module 1 | Part I |
| Common Technical Document Overview and Summaries |
Module 2 | Incorporated in Parts II, III and IV |
| Quality Documents | Module 3 | Part II |
| Non-Clinical Documents | Module 4 | Part III |
| Clinical Documents | Module 5 | Part IV |
All the administrative documents in Module 1 (ICH CTD) or Part I (ASEAN CTD) are submitted in soft copy in PRISM and the other parts of ICH CTD and ASEAN CTD can be submitted online via PRISM, CD/DVD or third-party cloud-based file exchange software (EasiShare).
The PRISM is the e-Service to carry out the transactions with the HSA.
Artixio provides following services for biological products in Singapore
- End-to-End services to commercialize the biological products in singapore
- Provide the effective Product Strategy
- Pre-submission preparation
- Dossier preparation and submission
- Providing response to Health Authority’s Queries
- Effective market access strategy
Why Artixio?
Our flexible business models help you scale globally
Experts with decades of successful product commercialization experience
Helping Top 10 Biopharma companies to develop innovative products
5000+ Licenses approved and maintained
ISO 9001: 2015 Certified company
Well networked with Global Health Authorities
FAQs
How is the therapeutic product evaluated in Singapore?
The therapeutic product in Singapore is evaluated through the following routes:
- Full Evaluation (For new product that has not been approved by any drug regulatory authority, applicable to NDA)
- Abridged Evaluation (For new or generic product approved by at least one drug regulatory authority, applicable to NDA & GDA)
- Verification (For new or generic product approved by the reference drug regulatory agencies, applicable to NDA & GDA)
- Verification CECA (For generic product manufactured in India and approved by the reference regulatory agencies, applicable to GDA of products manufactured in India)
What are the reference drug regulatory agencies recognized by Singapore?
US Food and Drug Administration (FDA), European Medicines Agency (EMA) via the Centralised Procedure, Health Canada (HC), UK Medicines and Healthcare Products Regulatory Agency (UK MHRA), Swissmedic and Australia Therapeutic Goods Administration (TGA)
How does your regulatory strategy support successful product registration in Singapore?
We provide a full-scale regulatory strategy with the following services for successful product registration in Singapore:
- Product registration strategy
- Writing for Clinical, Non-Clinical, and Quality modules
- Dossier Gap Analysis
- Dossier Preparation and Submission
- Pre-Submission meetings with Health Authority (HSA, Singapore)
- Response to Health Authority Queries
- Obtaining Successful approval and licenses
What will be the important points to consider during the pre-submission preparation for Singapore?
Following points should be considered before registering the product in Singapore:
- Identify the application type
- Decide the evaluation route to choose (can be decided with registration guides later)
- Choose the application dossier format (can be decided with registration guides later)
What are the conditions to decide the appropriate type of NDA application for my biological product?
Following conditions are considered to decide the appropriate NDA application type for a biological product:
| Application Type | Conditions |
|---|---|
| NDA-1 | For the first strength of a product containing a New Biological Entity |
| NDA-2 | For the first strength of a product containing: |
| New combination of registered biological entities | |
Registered biological entities in either:
|
|
| Registered biological entities with new route of administration | |
| For products not applicable under NDA-1 or NDA-3 | |
| NDA-3 | For subsequent strengths of a product registered or submitted as NDA-1 or NDA-2. Product name, dosage form, presentation, indication, dosing regimen, and patient population should be the same as NDA-1 or NDA-2. |
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