Your NPRA & MDA Gateway

Our Malaysia Services

Ready to Enter Malaysia's Growing Pharmaceutical Market?

Our Experiences

Our Establishment

Responsibilities of the Product Registration Holder (PRH)

Overview of Pharmaceutical Product Registration in Malaysia

Medicinal Product Classification in Malaysia

Medicinal products are classified into the following categories:

Registration Requirements for Pharmaceutical Products in Malaysia

International

Regional

• ASEAN Guidelines for Stability Process Validation Variation • ASEAN Common Technical Dossier (ACTD)

Local

The pharmaceutical product registration process in Malaysia involves the following key steps:

01

Determine Product Classification

02

Appoint an Authorized Representative

03

Submit Application via Quest 3+ System

04

Dossier Submission

05

Evaluation and Review

06

Approval and Registration Number Issuance

Authority Registration Timeline for Pharmaceutical Products in Malaysia

Authority Registration Fees for Pharmaceutical Products in Malaysia

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Commercial Access

License Holding

RLD and Bioequivalence

Regulatory Consultancy

Quality Management

Temperature Validation & Monitoring

Biologics

Natural Products

Veterinary Products

Medicinal Gas

New Drug Product (NDP)

Generics

Health and Food Supplements

Malaysia Pharmaceutical Registration

Regulatory . Certification . Licensing . Assurance

Exceptional Growth Opportunities in Southeast Asia

Let's Navigate Your NPRA & MDA Success

Singapore Malaysia Philippines Vietnam Thailand Hong Kong Taiwan Indonesia Services Commercial Access Regulatory Consultancy License Holding Quality Management System RLD and Bioequivalence Temperature Validation Contact Us Get In Touch 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

License Holding Load More RLD and Bioequivalence Load More Regulatory Consultancy Load More Quality Management Load More Temperature Validation & Monitoring Load More 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.

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.

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.

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.

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.

Prescription Medicine & Non-prescription Medicine, Over the Counter (OTC)

• WHO, ICH, EMA, US-FDA

• Drug registration guidance document

• NPRA guidelines

• DCA directives circulars

Proper classification of the product, such as prescription drugs, over-the-counter medications, or traditional medicines, is essential.

Foreign manufacturers must appoint a local authorized representative to liaise with NPRA.

Applications must be submitted electronically through NPRA’s online platform, including the complete product dossier.

The dossier must include comprehensive data on product formulation, manufacturing processes, stability studies, clinical trial data, and labeling.

NPRA evaluates the dossier for compliance with safety, quality, and efficacy standards. Additional documents or clarifications may be requested during this phase.

Upon successful evaluation, a product registration number (PRH) is issued, allowing the product to be marketed in Malaysia.

*Subject to change, always refer to the official website for the latest information

• 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

Our team is dedicated to ensuring your success in one of Southeast Asia’s most dynamic markets. Contact us now for a consultation and let us help you bring your products to market with confidence.

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