Strategic, End to End Partner in Malaysia for Pharmaceuticals

Regulatory Affairs, Market Access, Pharmacovigilance Support in Malaysia

Pharmaceuticals

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

Artixio’s Services in Malaysia for Pharmaceuticals

Pre-Registration

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?

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.

Strategic, End to End Partner in Malaysia for Pharmaceuticals

Pharmaceuticals

Services We Offer

Solution by Countries

Our Industries

Regulatory Affairs

Product Registration

IND (Investigational New Drug)

NDA (New Drug Application)

Technical Writing

Regulatory Strategy

Digital Marketing

Market Access

Regulatory Operations

Regulatory Authorities in Malaysia

Classification of Pharmaceuticals in Malaysia