Malaysia has developed a robust and evolving regulatory system to govern the safety, efficacy, and quality of medicinal products. At the core of this system is the 1984 regulation – Control of Drugs and Cosmetics Regulations (CDCR). These regulations set the legal foundation for drug registration in the country and empower the Drug Control Authority (DCA) to oversee the full lifecycle of pharmaceutical products — from registration and licensing to post-market surveillance and enforcement.
Serving as the operational arm of the DCA, the National Pharmaceutical Regulatory Agency (NPRA) functions as the secretariat and handles all administrative and scientific activities associated with product registration. Together, these entities ensure that Malaysian consumers have access to safe, effective, and high-quality medicinal products.
Regulatory Framework and Core Requirements
Under Regulation 7(1) of the CDCR 1984, it is explicitly stated that, unless otherwise provided, no person shall manufacture, sell, supply, import, possess, or administer any medicinal product unless:
- The product is registered with the DCA, and
- The individual or entity holds the appropriate license issued under the regulations.
This clause makes product registration and licensing mandatory and underscores the Malaysian government’s commitment to upholding pharmaceutical standards and protecting public health.
What Qualifies as a “Product”?
An essential first step in the registration process is determining whether an item falls within the definition of a “product” as per Regulation 2 of the CDCR 1984. The definition includes:
- Any drug intended for administration to humans or animals for a medicinal purpose, or
- Any drug to be used as an ingredient in a preparation for such a purpose.
The term “drug” is broadly defined under the 1952 Sale of Drugs Act and encompasses substances used for diagnosing, treating, preventing, or curing diseases, as well as for purposes like contraception, inducing anesthesia, modifying physiological functions, controlling body weight, or promoting general well-being.
Product Classification
Once a product is determined to fall under the regulatory definition, it must be correctly classified. This step is critical, as different categories require different documentation, fees, and evaluation pathways. Categories of products include:
- New Drug Products
- Biologics
- Generic Products
- Health Supplements
- Natural Products
- Veterinary Products
If a product falls into a grey area, such as medical device-drug-cosmetic interphase (MDDCI), the applicant may submit a Classification Form to the NPRA for official guidance. These interphase categories are particularly relevant for combination products or those with therapeutic claims that may overlap regulatory boundaries.
Eligibility and Role of the Product Registration Holder (PRH)
Only companies incorporated in Malaysia and registered with the Companies Commission of Malaysia (SSM) are eligible to act as the Product Registration Holder (PRH). The PRH must have a permanent address in Malaysia and be involved in the healthcare or pharmaceutical sector.
If the applicant is not the owner of the product, they must provide written authorization from the product owner designating them as the PRH. This entity then becomes solely responsible for all regulatory matters, including submission accuracy, product quality, and communication with the NPRA.
Key Responsibilities of the PRH
The PRH has a legal obligation to maintain the accuracy and integrity of all information submitted to NPRA. The PRH must:
- Ensure that all submissions are complete, truthful, and timely
- Respond to requests for supplementary information, documents, or samples within the stipulated deadlines
- Notify the Authority of any changes in product composition, manufacturing site, packaging, labeling, or ownership
- Monitor and report any adverse events or product issues
- Maintain compliance with current Good Manufacturing Practice (cGMP)
Regulation 8(5) requires notification within 14 days of any change to submitted information. Failure to comply may lead to the application being rejected or the registration being withdrawn. Under Regulation 8(9), knowingly submitting false or misleading information constitutes an offence.
Importantly, in the event of disputes with product owners or third parties, NPRA will only correspond with the PRH and will not intervene in private contractual matters. It is the PRH’s duty to resolve these disputes independently.
Online Submission via the QUEST System
Malaysia’s registration process is fully digitized through the QUEST system, an online portal managed by NPRA. All submissions must be completed through this system.
To use QUEST, applicants must:
- Register for a QUEST membership
- Purchase a USB Token containing a User Digital Certificate from MSC Trustgate.com Sdn. Bhd.
- Install the token on their computer system for secure login and data submission
This system streamlines application tracking, fee payment, and communication with the Authority. However, the PRH is responsible for safeguarding their token. Any fraudulent use may result in severe penalties and revocation of access.
Application Fees
The CDCR allows NPRA to charge applicants for the cost of product evaluation and related investigations. Fee details are outlined in Appendix 9 of the NPRA guidelines. Key points include:
- Fees must be paid via the QUEST system using FPX, credit card, or through official bank instruments
- Each application requires a separate payment
- Once submitted and accepted, fees are non-refundable
- Applications submitted without payment or with incorrect fees will not be processed
Applicants are advised to carefully review the fee schedule and confirm payment details to avoid delays or rejections.
Preparing the Submission
Thorough preparation is vital for a successful application. Applicants should take the following steps:
- Determine the product category and confirm the classification
- Identify the appropriate evaluation pathway (standard, abridged, verification-based)
- Prepare all required documentation and data
- Schedule a Pre-Submission Meeting (PSM) with NPRA for guidance, if needed
Pre-submission meetings are particularly useful for complex products, biologics, or those involving new chemical entities. Guidance documents on how to conduct these meetings are available on the NPRA website.
Data Exclusivity in Malaysia
Malaysia provides data exclusivity for new drug products that contain a New Chemical Entity (NCE) or that are registered for a new indication. This protection covers undisclosed, unpublished data submitted for scientific evaluation. To qualify, the data must have been generated through considerable effort and not be in the public domain.
There are two main types of protection:
- Data exclusivity for new drugs with a New Chemical Entity
- Data exclusivity for a second indication of an already registered drug
Details of drugs granted data exclusivity can be found in the public registers on the NPRA website.
Post-Registration Obligations
Product registration is not the end of the regulatory journey. Once approved, the PRH must continue to meet a range of obligations:
- Notify NPRA of any changes in product details, manufacturing processes, or contact information
- Submit periodic safety reports and adverse event data
- Maintain updated records and documentation on product efficacy and safety
- Obtain prior approval before making any changes to the product formulation, packaging, or label
- Inform NPRA if the product is withdrawn from the market or discontinued
In cases where the PRH ceases operations, NPRA must be notified immediately. It is the responsibility of the existing PRH to manage any ownership transfers or re-registration efforts.
Conclusion
Malaysia’s drug registration process is designed to protect public health while supporting industry innovation. Governed by the 1984 Control of Drugs and Cosmetics Regulations and administered through the NPRA, the system ensures that all medicinal products meet rigorous standards before they are made available to the public.
From product classification and PRH responsibilities to the QUEST submission process and data exclusivity protections, every step is carefully regulated. Companies looking to enter the Malaysian pharmaceutical market must be prepared to navigate a thorough and structured process. With diligence, transparency, and proper planning, the process can be completed efficiently, contributing to both business success and public safety.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.