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Malaysia Pharmaceutical Registration
Your NPRA & MDA Gateway
Regulatory . Certification . Licensing . Assurance
Navigate Malaysia's growing pharmaceutical market with expert local guidance. Our Malaysia-based team provides comprehensive NPRA and MDA registration services to capture opportunities in this rapidly expanding MYR6+ billion market projected to reach MYR10 billion by 2024.
Why Malaysia
Exceptional Growth Opportunities in Southeast Asia
Rapidly Expanding Pharmaceutical Market
Malaysia's pharmaceutical industry is a rising star in Southeast Asia, contributing significantly to the country's economy and healthcare landscape. With a market exceeding MYR6 billion and projected to reach MYR10 billion by 2024, it's a sector brimming with potential.
Key Market Drivers:
• Rising healthcare demand from aging population
• Increasing disposable incomes driving pharmaceutical consumption
• Growing demand for affordable alternatives to brand-name medications
• Innovation opportunities to address unmet medical needs
Government Support & Incentives
Government support enhances the industry's growth potential through:
• Tax breaks and financial incentives for pharmaceutical companies
• Special economic zones designed to attract pharmaceutical investments
• Commitment to supporting continued industry expansion
• Regulatory framework improvements to facilitate market access
Our Malaysia Services
Regulatory Framework Structure
Malaysia operates a comprehensive dual-authority regulatory system:
National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia:
• Prescription medicines registration
• Essential drugs approval
• Over-the-counter (OTC) products
• Traditional medicines registration
• Health/food supplements
• Cosmetics regulation
Medical Device Authority (MDA):
• Complete medical devices sector control
• Device registration and approval processes
• Post-market surveillance and compliance
Market Access Challenges & Opportunities
The regulatory environment in Malaysia can be complex and time-consuming, which can present challenges in the supply of new drugs and medical devices to the market. Despite these challenges, the future of the Malaysian pharmaceutical industry is bright, poised for continued expansion with strong government commitment to supporting the industry.
Ready to Enter Malaysia's Growing Pharmaceutical Market?
Let's Navigate Your NPRA & MDA Success
Don't let regulatory complexity delay your entry into Malaysia's rapidly expanding pharmaceutical market. Our Malaysia-based regulatory experts, with deep NPRA and MDA knowledge, are ready to accelerate your market access in this MYR6+ billion market projected for significant growth.
Contact us today to discuss how our Malaysia expertise can position you for success in Southeast Asia's rising pharmaceutical star.
Our Experiences
Secured over 20 drug licenses for wide range of product types including NCE, Generics, Biologics/Biosimilars, Drug-Medical Device Combination Products, Supplements, 5 medical device licenses, and 35 cosmetics licenses.
Product Registration Holder as Regulatory and Local Responsible Person in Pharmacovigilance, liaison with National Pharmaceutical Regulatory Agency (NPRA, efficiently handling queries and regulatory communications for Product Registration Holder (PRH) approval.
Handled PRH Transfers, regulatory support for transfer inventory and grace period between Product Owner and Distributor.
Authorization of Importers
Provided comprehensive life cycle management including variations, pharmacovigilance services such as PSUR submission, ICSR, product defect handling, etc.
Provided strategic regulatory intelligence reports, dossier gap analysis to facilitate successful market entry ensuring seamless market entry and compliance.
Handled Product Owner regulatory and Pharmacovigilance Audits
Efficient coordination of pre-submission meetings for technical and clinical studies consultation with the National Pharmaceutical Regulatory Agency (NPRA).
Expertly managed NPRA PIC/S GMP inspection applications for foreign manufacturing sites.
Our Establishment
To become a Product Registration Holder (PRH) in Malaysia, an applicant must be a locally incorporated company or legal entity registered with the Companies Commission of Malaysia (SSM) with (with business scope related to health/ pharmaceutical product) and have a permanent address.
If the applicant is not the product owner, written authorization from the product owner is required to assign the PRH as responsible for the quality, safety, and efficacy of the product.
Responsibilities of the Product Registration Holder (PRH)
1. Ensure all transactions with NPRA are conducted by their appointed person(s).
2. Comply with all legal provisions in Malaysia and indemnify the government for claims arising from legal breaches.
3. Ensure the accuracy of all submitted quality, safety, and efficacy information and notify the Authority promptly of any changes.
4. Respond to requests for supplementary data, information, or samples within the specified time frame or request an extension if needed.
5. Note that applications will be rejected if required documents are not submitted within six (6) months from the first correspondence.
6. Manage all matters related to the quality, safety, and efficacy of registered products, including:
(i) Updates on product quality and compliance with current Good Manufacturing Practice (cGMP).
(ii) Notification of product registration withdrawal with reasons.
7. Provide any documents, items, or information required by the Authority.
8. Obtain prior approval for changes to registered product details such as composition, origin, or labeling.
9. Notify the Authority of changes in correspondence details (e.g., name, address, contact).
10. Inform the Authority immediately if ceasing as the PRH.
11. Note that NPRA corresponds only with the existing PRH and does not engage with third parties.
12. Resolve disputes independently, including those involving the product owner or contractual matters, as NPRA will not intervene.
Product registration applications in Malaysia must be submitted via the local online submission platform: QUEST 3+ system by the Product Registration Holder (PRH). The PRH must be a locally incorporated company or legal entity registered with the Companies Commission of Malaysia (SSM), with a business scope related to health or pharmaceutical products and have a permanent address. Compliance with all requirements for QUEST system access and usage is mandatory, including the secure handling of authorized USB tokens used for submissions. The National Pharmaceutical Regulatory Agency (NPRA) reserves the right to approve or reject applications for QUEST membership.
Our establishment is fully equipped to handle product registration in Malaysia, with all the necessary licenses and expertise. We operate as a locally incorporated company registered with the Companies Commission of Malaysia (SSM) and maintain an active QUEST 3+ account for seamless regulatory submissions. Additionally, we provide a dedicated local liaison who ensures compliance with all NPRA requirements, offering comprehensive support throughout the registration process and product life cycle management.
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Overview of Pharmaceutical Product Registration in Malaysia
The Malaysian National Pharmaceutical Regulatory Agency (NPRA), under the Ministry of Health (MOH), is the authority responsible for evaluating and approving pharmaceutical products. The process involves multiple steps to ensure that products meet stringent safety, quality, and efficacy standards.
Medicinal Product Classification in Malaysia
Medicinal products are classified into the following categories:
Biologics
Natural Products
New Drug Product (NDP)
Registration Requirements for Pharmaceutical Products in Malaysia
International
• WHO, ICH, EMA, US-FDA
Regional
• ASEAN Guidelines for Stability Process Validation Variation
• ASEAN Common Technical Dossier (ACTD)
Local
• Drug registration guidance document
• NPRA guidelines
• DCA directives circulars
The pharmaceutical product registration process in Malaysia involves the following key steps:
01
Determine Product Classification
Proper classification of the product, such as prescription drugs, over-the-counter medications, or traditional medicines, is essential.
02
Appoint an Authorized Representative
Foreign manufacturers must appoint a local authorized representative to liaise with NPRA.
03
Submit Application via Quest 3+ System
Applications must be submitted electronically through NPRA’s online platform, including the complete product dossier.
04
Dossier Submission
The dossier must include comprehensive data on product formulation, manufacturing processes, stability studies, clinical trial data, and labeling.
05
Evaluation and Review
NPRA evaluates the dossier for compliance with safety, quality, and efficacy standards. Additional documents or clarifications may be requested during this phase.
06
Approval and Registration Number Issuance
Upon successful evaluation, a product registration number (PRH) is issued, allowing the product to be marketed in Malaysia.
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Authority Registration Timeline for Pharmaceutical Products in Malaysia
Application Type | Product Category | Timeline (Working Days) |
|---|---|---|
Abridged Evaluation | Generic (Non-Scheduled Poison) | |
• Single Active Ingredients | 116 | |
• Two or More Active Ingredients | 136 | |
Full Evaluation | New Drug Product (Hybrid) | 210 |
Generic (Scheduled & Non-Scheduled Poison) | ||
Full Evaluation | New Drug Products (NCE) | 245 |
Biologics |
*Subject to change, always refer to the official website for the latest information
Authority Registration Fees for Pharmaceutical Products in Malaysia
Product Category | Processing Fees (RM) | Analysis Fees | Analysis Fees | Total Fees (RM) |
|---|---|---|---|---|
Single Active Ingredients | Two or More Active Ingredients | |||
New Drug Product | 1,000 | 3,000 | 4,000 | |
1,000 | 4,000 | 5000 | ||
Biologics | 1,000 | 3,000 | 4,000 | |
1,000 | 4,000 | 5,000 | ||
Generics | 1,000 | 3,000 | 4,000 | |
1,000 | 4,000 | 5,000 |
*Subject to change, always refer to the official website for the latest information
How can we help?
• Pre-Market Strategic Consulting and Feasibility Assessment
• Regulatory intelligence and market entry strategy
• Product classification and regulatory gap analysis
• GMP compliance auditing and advisory
• NPRA PIC/s GMP inspection application & local responsible person
• Dossier preparation and submission handling
• Local Entity Support
• Life Cycle Management such as post-market surveillance and pharmacovigilance support
• Pre-submission consultation activity with Health Agency
• Import License Application
• Change of Product Registration Holder
• Ad-hoc Regulatory Affairs Consultation
