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NPRA Product Registration

NPRA product registration

The National Pharmaceutical Regulatory Agency (NPRA), formerly known as the National Pharmaceutical Control Bureau (NPCB) – was set up in October 1978 under the quality control activity of Pharmacy and Supply Programme. The institution was established to implement quality control on pharmaceutical products. The infrastructure and facilities were designed to meet the requirements for testing and quality control activities. NPRA was recognised globally in 1996 by the World Health Organisation (WHO) as a “WHO Collaborating Centre for Regulatory Regulation of Pharmaceuticals”. 

This international recognition by WHO is an appreciation of the work NPRA have put into in the regulatory areas. NPRA product registration main objective is to ensure that therapeutic substances approved for the local market are safe, effective and of quality and also to ensure that cosmetic products approved are safe.

The candidate of NPRA is known as the Product Registration Holder (PRH). A PRH must be a company that is registered locally or a legal entity with a residency permit and enrolled with the Commission of Companies of Malaysia (with a pharmaceutical/health product sector of work). Since only Malaysian companies are referring this registration for such items, foreign companies who plan to register their products would have assign a local agent (registered in Malaysia) as their local representative. Therefore, the local agent would be the one in charge relating to the product quality, safety and effectiveness.

Control of drugs and cosmetics Regulation CDCR 1984, Regulation 7(1) asserts :

No individual or company shall produce, market, supply, import, own or control any commodity unless :

a. The product is a licensed and registered product.

b. The individual owns the requisite and issued a valid licensed under these regulations.

Roles and functions of NPRA

• To implement the drug registration/cosmetics notification scheme through evaluation of technical data, laboratory analysis, research and information received from international agencies.
• To carry out all analytical, pharmaceutical, microbiological and pharmacological test on drugs and cosmetics to determine quality and safety of the products.
• To implement the regulatory scheme on quality of pharmaceutical manufacturers, importers and wholesalers including a licensing scheme for clinical trial.
• To encourage and assist pharmaceutical manufacturers to upgrade manufacturing standards to levels equivalent to the requirements of Good Manufacturing Practice as recommended by the World Health Organisation (WHO).

which products need to be registered with nPRA?

All pharmaceutical items that contained scheduled poison are also known as controlled poison / controlled medicine.

Non-scheduled poison - containing prescription products  (known as OTC products) which include below :
•    Antiseptic / Disinfectant Designed For Human Body Use
•    Medicated-Plaster
•    Human-Use Medical Agents
•    Supplemental Diet i.e : Chitosan / Probiotics

Traditional Goods which include below :
•    Homeopathic Drugs
•    Medicines From Ayurvedic
•    Plaster-Medicated
•    Herbaceous Tea
•    Dietary Pills i.e : Spirullina, Chlorella, Aloe Vera Juice, Chicken Extract etc

Veterinary products which includes Oral solution, Oral suspension, emulsion :
•    Granule
•    Paste
•    Water Soluble Powder
•    Injectable
•    Powder For Injection
•    Oral Powder
•    Capsule / Tablet
•    Topical Ophtalmic And Otic Products

Procedure for pharmaceutical product registration

Product registration can be submitted online via Quest System. Applicant must apply for Quest membership and purchase a USB token before they can proceed with the registration. Once applicant received the USB token, then only he/she can enter the registration site and proceed with online submission. The summary of the online registration are as follows :

Step 01
Go to NPRA website (www.npra.gov.my) > Industry > First timer user > USB token.
2
Step 02
Apply for Quest membership. Requirements needed : Company Registration Form Company Authorisation Letter I/C Photocopy
3
Step 03
Upon Quest membership approval, purchase USB token from MSC Trustgate.
4
Step 04
Login Quest to submit product registration application.
5
Step 05
Submit data requested.
6
Step 06
Correspond with NPRA officer if additional data is needed.
7
Step 07
Products tabled to DCA meeting.

Processing Fee For NPRA Product Registration

Every application for registration shall be accompanied with processing fee as follows :

01. New Chemical Entity : processing fee is RM1,000, analysis fee for single active ingredient RM3,000 whereby two active ingredients is RM4,000.

02. Pharmaceutical : processing fee is RM1,000, analysis fee for single active ingredient RM1,200 whereby two active ingredients is RM2,000.

03. Traditional : processing fee is RM500 whereby the analysis fee is RM700

Additional Information:
(a)
Application without the correct fees will not be accepted.
(b) Foreign currencies are not acceptable.
(c) The processing fee is NOT REFUNDABLE.

Other charges - The DCA will charge any applicant such cost as it may incur for the purpose of carrying out laboratory investigation/testing prior to the registration of any product.

Mode of payment - The processing fee and any other charges shall be paid in a form of a bank draft or money order made payable to "Biro Pengawalan Farmaseutikal Kebangsaan".

Time-Frame For Each NPRA Product Registration 

01. The evaluation process for prescription drugs, non-prescription drugs, new drugs and biological usually takes around 210 to 245 working days.

02. The evaluation process for both health supplements and traditional products containing one or two active ingredients usually takes around 116 to 136 working days. 

To get more information on NPRA product registration, you may click here.

how can foreign companies sell pharmaceutical products in Malaysia?

All pharmaceutical products need to be registered under Drug Control Authority, before being able to be commercialised in Malaysia. NPRA demands a local representative for all foreign companies who plan to introduce, sell and market pharmaceutical and cosmetics products to the Malaysian market. Hence, foreign companies who are looking to promote pharmaceutical products in Malaysia first have to find a local agency (a company that registered in Malaysia) that can assist them on the NPRA product registration. By getting a Malaysian agency to assist you with the NPRA product registration can benefit you in a way that you save a lot of time and money on the wrong application process. It can also help you to understand the process better and comply with the regulatory laws in Malaysia. With DagangHalal, we can help to assist you with the NPRA product registration in Malaysia as well as guiding you on every step of the application process. 

Frequently Asked Questions (FAQs)

How do I register my product with NPRA?

1) Go to NPRA website (www.npra.gov.my) > Industry > First time user > Register USB Token.
2) Apply for QUEST membership.
3) Upon QUEST membership approval, purchase USB token from MSC Trustgate.
4) Login Quest to submit product registration application.

What are the products that need to be registered with NPRA?

The products that need to be registered with NPRA include all pharmaceutical items that contain scheduled poison and non-scheduled poison - which contain prescription products, traditional goods for examples dietary pills and veterinary products including water soluble powder, capsule or tablet.

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