• What is NPRA Registration?
    • National Pharmaceutical Regulatory Agency (NPRA) falls under the Ministry of Health Malaysia (MOH). NPRA is the key regulatory body for pharmaceutical products in Malaysia, ensuring that medicines and health supplements meet the required safety and efficacy standards, while being governed by the Ministry of Health.
    • In Malaysia, the NPRA’s tasks are to enforce the drug registration/cosmetic confirmation scheme through scientific data assessment, laboratory review, testing, and information obtained from international agencies. In addition to performing medicinal, microbiological, and pharmacological medication and cosmetic testing to assess the quality, effectiveness, and safety of those drugs, the introduction of a regulatory scheme by the National Pharmaceutical Regulatory Agency for the quality of pharmaceutical products and the implementation of a licensing system for drug producers, importers, distributors, and wholesalers, including a clinical trial licensing scheme.
  • Who Needs It?
    • Businesses importing or manufacturing pharmaceuticals, medical devices, cosmetics, etc. are required to be registered with NPRA. All products under these categories – pharmaceuticals, medical devices, cosmetics, etc. are required to be registered with NPRA before they are sold to Malaysian consumers. NPRA is responsible for evaluating and approving pharmaceutical products (including medicines, health supplements, and cosmetics) before they can be sold in Malaysia. Only products that meet NPRA’s safety, quality, and efficacy standards are granted market authorization.
    • NPRA categorizes the products for application and candidates should first determine their applications among the following: new drugs, biologics, generics, health supplements; and natural products.

Which Product Registration Need to be Registered to NPRA?

  1. All Pharmaceutical items that contain scheduled poisons are also known as controlled poison or controlled medicine.
  2. Non-scheduled poison-containing prescription products (also known as OTC products)
    1. These include below:
    2. Medicated plaster
    3. Antiseptic/ Disinfectants designed for human body use
    4. Human-use medical agents (in vivo)
    5. Supplemental diet, e.g., Chitosan, Probiotics
  3. Traditional goods
    1. These include below:
    2. Homeopathic drugs
    3. Medicines from Ayurvedics
    4. Plaster-medicated
    5. Herbaceous teas
    6. Dietary pills, for example, Spirulina, Chlorella, Royal Jelly, Bee Pollen, Noni juice, Aloe Vera juice, Chicken Extract, etc.

How to Apply for Pharmaceutical Products Registration to NPRA?

There is the option to register online via the Quest 3 system on the National Pharmaceutical Regulatory Agency website. Although, before proceeding with registering, an applicant should pertain for a Quest 3 membership and buy a USB token. Upon receipt of the USB token by the applicant, the applicant will be able to access the enrollment site and continue with the online application.

The overview of the process for the online NPRA product registration by the National Pharmaceutical Regulatory Agency is stated below:

1) Visit NPRA (www.npra.gov.my) website > Industry > First Time User > USB Token Registry.

2) Apply for Membership in NPRA QUEST 3.

What are the requirements?

  • Form for Company Registration
  • Letter of Company Authorization
  • I/C photocopy

3) Buy the USB Token Quest 3 from MSC Trustgate following Quest membership acceptance.

4) Login Quest 3 for uploading applications for product registration.

5) Send the requested details to the National Pharmaceutical Regulatory Agency.

6) Respond to the NPRA officer when supplementary information is needed.

7) Items proposed at the meeting of the DCA

Fees for Pharmaceutical Product Registration in NPRA

Every product application requires an application fee payable to NPRA, subject to any change by NPRA:

Processing fee
Every application for registration shall be accompanied with a processing fee, as follows (effective January, 2007) :-

NoProduct ClassificationProcessing Fees (RM)Analysis Fees (RM) Total Fees 
 1 New Chemical Entity 1,000.00 Single active ingredient : 3,000.00 4,000.00
    Two or more active ingredients : 4,000.00 5,000.00
2  Pharmaceutical 1,000.00 Single active ingredient : 1,200.00 2,200.00
    Two or more active ingredients: 2,000.00 3,000.00
 3 Traditional 500.00 700.00 1,200.00

How Long does it Take to Register a Pharmaceutical Product in Malaysia?

The duration for each product to be registered is calculated from the date of final and complete submission.

Below are the timeline for product of each category:

Category of productTimeline
Full Evaluation 
To evaluate application for registration of :Prescription drugsNon- prescription drugsNew drugs and biologicals210 working days *210 working days *245 working days *
Abridged Evaluation 
To evaluate application for registration of health supplements and traditional products containing:Single active ingredient2 or more active ingredients* Upon receipt of complete application116 working days *136 working days *

What Happens After Registering a Product in NPRA?

After registering your product to the NPRA system, based on your company type and activity, you need to take a manufacturer/ import/ wholesale license.

A business that intends to produce, import, and/or wholesale any licensed/notified goods must first apply for a Manufacturer’s License, Import License, and/or Wholesaler’s License after the item is licensed or notified.

Compliance with Good Manufacturing Practice (‘GMP’) and Good Distribution Practice (‘GDP’) is a requirement for both product registration/cosmetic notification and the application for a manufacturing license.

The processing fees are as below:

LicenseRegistration feeTimeline *Validity
1. Import licenseRM 500Not more than 1 month1 year
2. ManufacturerRM 1000Not more than 1 month1 year
3. WholesalerRM 500Not more than 1 month1 year

While on the other hand, a business wishing to manufacture an unregistered drug with the intent of a clinical trial must apply for an Import License for a Clinical Trial. A Clinical Trial Exemption from the NPRA is necessary for products that are not licensed that are meant to be produced locally for the purpose of a clinical trial.

An exception for the production of a sample should be extended to those who intend to produce any substance solely for the aim of generating a specimen for product registration (applies to locally produced goods only).

Labeling for Security Regulations (Hologram)

What kinds of items need security labeling?

The requirement for product labeling to be affixed to this protection system extends to all licensed medicinal products, traditional products, and nutritional supplements by the National Pharmaceutical Regulatory Agency.

Non-registered goods shall be deemed to be all products without security marking.

Why Choose Us?

We offer strategic advisory and product registration advice and help you connect with the National Pharmaceutical Regulatory Agency, NPRA, for a broad variety of product applications, namely pharmaceuticals, cosmetics, OTC, and controlled substances. The areas of consultancy in product registration, application, revision and follow up include below:

  • Examples of registration of medicinal products include scheduled poisons, also known as controlled poison or regulated drugs, and also non-scheduled poison products (OTC).
  • Traditional medicine, medicinal products, medicated wine, medicated oil, and so on are examples of natural products.
  • Vitamins, minerals, amino acids, fatty acids, antibiotics, probiotics, and other bioactive compounds are examples of dietary supplements.
  • Application for Import License: In order to import and export wholesale or import licensed goods from their premises, we help importers apply for an import license.
  • To register cosmetic products for manufacturing, distributing, and marketing in Malaysia
  • Skin exfoliation products, perfume, facemask, hair products, make-up products, sunbathing goods, anti-wrinkle, and anti-aging product lines, and so on are exemplars of cosmetic products.

Source: NPRA Product Registration