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Pharmaceutical Regulatory Solutions In Malaysia
Expert pharmaceutical regulatory services and consulting in Malaysia for product registration, dossier prep, and market compliance support. Regulatory Affairs, Market Access, Pharmacovigilance Support in Malaysia
Pharmaceuticals
Regulatory Affairs
Product Registration
IND (Investigational New Drug)
NDA (New Drug Application)
Technical Writing
Regulatory Strategy
Digital Marketing
Market Access
Regulatory Operations
With $1.7 billion in market size and a regulated governance for pharmaceutical product safety, ease of business and streamlined governance, Malaysia is an important strategic country for international manufacturers. Artixio’s team in Malaysia brings decades of experience in successfully launching complex pharmaceutical products through experienced based regulatory services, evidence based market access and pharmacovigilance to support product lifecycle from strategy to registration and post approval maintenance.
Regulatory Authorities in Malaysia
National Pharmaceutical Regulatory Agency (NPRA) is the governing body that regulates the pharmaceutical products in Malaysia with Malaysia Drug Control Authority (DCA) to ensure safety and efficacy of drugs placed in the country. NPRA accepts applications in ACTD format with additional specifications as per local country requirements. QUEST 3+ is the online submission system provided by NPRA where manufacturers can submit their applications for new drugs and generics.
Classification of Pharmaceuticals in Malaysia
- New Drug Products
- Generic Drugs, Prescription
- Over the Counter (OTC) Generics
- Biologics
Artixio’s Services in Malaysia for Pharmaceuticals
Pre-Registration
- Local Representative
- Regulatory Intelligence & Strategy
- Dossier Gap Analysis
- HA Meetings and Consultation with NPRA
- Import Strategy
Registration
- Local Representative Local Representative
- Dossier Preparation
- Submission of Application
- Medical Writing
- Clinical Trials / BE Studies Support
- Response to CDSCO Queries
- Import License
- Market Access Pricing & Reimbursement
- Labeling and Artwork
Post Market
- Local Representative
- Post Approval Lifecycle Maintenance
- Renewals
- Advertisement & Promotional Material Review
- Variations
- Line Extensions
- Import Assistance
- Tender Support
- Ongoing Regulatory Intelligence and Monitoring
Why Artixio For Your Pharma Services in Malaysia?
Strong understanding of NPRA requirements
Help navigate variation filing and renewals
Support for full product registration and post-approval updates
Wide Therapeutic Areas, Formulation and Route of Administration Experience
Guidance on local labeling and Bahasa compliance
Flexible support for both new entrants and established brands
Experience working with local agents and product holders
Fast, clear communication with minimal back-and-forth
FAQs
1. What are applicable pathways for registration of pharmaceutical products in Malaysia?
Based on the product type, its status and available data, following evaluation pathways are applicable in Malaysia by NPRA.
- Full Evaluation Route, required for new chemical entities and biologics
- Full Evaluation – Conditional Review Route, required for product meeting specific conditions, additional data may be required
- Full Evaluation via Abbreviated Review Route, required for products approved in reference countries
- Abridged Evaluation Route, required for generics with substantial data
- Priority Review Route, applicable for products suitable for urgent public health needs Special Review, applicable for approval of compassionate use or orphan drugs
2. What are the reference countries accepted by NPRA in Malaysia?
US FDA, EMA, Health Canada, TGA Australia, UK MHRA, Swissmedic, PMDA (Japan) are some acceptable reference countries. Consultation with HSA is recommended based on product status.
3. Do you provide advisory services and regulatory intelligence for decision support in Malaysia?
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 NPRA requirements. QuriousRI, a regulatory intelligence platform from Artixio monitors updates from health authority on continuous basis evaluating their impact on different pharmaceutical products.
4. How can foreign manufacturer register pharmaceutical drugs in Malaysia?
A local registered agent is required by NPRA to apply for pharmaceutical marketing authorization in Malaysia. For registration, applicants must obtain the QUEST3 membership and buy a USB token to proceed with application submission and respond with supplemental information required by NPRA.
5. What are the agency fees for registration of pharmaceutical products in Malaysia?
The fee varies depending on the product. For New Chemical Entity, the application processing fee is RM1000; RM3000 for single active ingredient and RM 4000 for two or more ingredients. For generic drugs, the fee is RM1000, single active ingredient is RM 1200 and RM2000 for two or more active ingredients.
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