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End-to-End Service Provider for Biologics in Malaysia
A trusted service provider with cutting edge consulting capabilities to develop innovative products and address unmet medical needs.
At Artixio with over 250 regulatory experts in 120+ countries, we support our client throughout their product commercialization journey. We are committed to excellence and driving innovation and expanding access to life-changing solutions for people around the world. Our team is the blend of domain expertise, legal insight, marketing, and business acumen to seamlessly guide your product from concept to market.
Regulatory Body of Malaysia
The National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health is National Regulatory body of Malaysia for the regulatory control of medicinal products and cosmetics in Malaysia.
Overview of Biologics in Malaysia
Biologic/Biological product in Malaysia are the products whose active ingredient is made or derived by from living organism for e.g., plant, human, animal or microorganism and may be produced by biotechnology methods and other cutting-edge technologies. This product imitates natural biological substances such as hormones, enzymes or antibodies in the human body.
Registration of biologics in Malaysia
To register the biologic product in Malaysia, the online QUEST3+ system is used. To carry out the transactions, applicants must register membership and purchase a digital certificate in the form of a USB token.
Following steps are involved for product registration in Malaysia
Step I: Preparation
It involves
- Product Classification
- Token Configuration
- Payment Mode
- Patent and Data Exclusivity Status
- Ensuring key documents availability
Step III: Regulatory Outcome
Evaluation of the documents and decision on approval of the application by Drug Control Authority (DCA)
Step II: Submission
The registration dossier is submitted in ICH CTD or ASEAN ACTD format.
Step IV: Post-Registration Process
It includes
- Maintenance of Registration
- Withdrawal of Product Registration
- Amendment to the particulars of the Product
- Post-Marketing Activities
Artixio provides following services for biologics in Malaysia
- Quality Gap Analysis & QMS implementation
- Easy market access of the product
- Innovative branding and marketing strategies
- Supports regulatory operations
- New Product Registration
- Post Approval Maintenance
- Dossier Preparation & Submission
- Health Authority Liasion
Why Artixio?
250+ global regulatory experts
Regional expertise
Well networked with Health Authorities
Evidence based solutions for successful commercialization of the product
5000+ Licenses approved and maintained
FAQs
Does NPRA accept the GMP Certificate from other PIC/S Member countries?
Yes, NPRA is the member of Pharmaceutical Inspection Cooperation Scheme (PIC/S) which enables it to accept GMP Certificates and inspection certificates from other PIC/S member regulatory authorities, as well as National Regulatory Authorities with a cooperation agreement, such as an MRA, with PIC/S.
What are the reference regulatory authorities for Malaysia (NPRA)?
European Medicines Agency (EMA), Health Canada, Health Sciences Authority (HSA) Singapore, Medicines and Healthcare Products Regulatory Agency United Kingdom (UK MHRA), Pharmaceuticals and Medical Devices Agency (PMDA) Japan, Swissmedic, Therapeutic Goods Administration (TGA) Australia, United States Food and Drug Administration (USFDA)
What is the timeline for a biologic product evaluation in Malaysia?
| Evaluation Type | Timeline |
|---|---|
| Full Evaluation | 245 working days |
| Priority Review | 120 working days (From the date of approval of priority review) |
What are the registration fees for a Biologic product in Malaysia?
| Processing Fees (RM) | Analysis Fees (RM) | Total Fees (RM) |
|---|---|---|
| 1,000.00 | Single active ingredient: 3,000.00 | 4,000.00 |
| Two or more active ingredients: 4,000.00 | 5,000.00 |
What are the evaluation routes for product registration in Malaysia?
There are following 4 methods of evaluation for product registration in Malaysia:
- Full Evaluation (Standard Pathway)
- Full Evaluation (Conditional Registration)
- Full Evaluation via Facilitated Registration Pathway (Abbreviated and Verification Review)
- Abridged Evaluation
How Artixio’s services help ensure the ongoing safety and efficacy of products after market entry?
Our services include continuous monitoring of product performance, collecting and analyzing adverse event data, and ensuring compliance with global regulatory requirements. Our experts’ team conducts thorough risk assessments, prepares detailed PMS reports, and provides actionable insights to mitigate potential risks. We use advanced data analytics and maintain close regulatory collaboration which helps our clients to ensure safety and compliance of the product and thereby protecting public health.
Regulatory Expertise Across
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Malaysia
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