NPRA Malaysia: What You Need To Know

When you click into this article, I assume that you are either working in a health or beauty-related industry with the intention to produce dietary supplements or what not. If so, then you did the right thing by even starting to read the first few lines of this article because NPRA Malaysia or NPRA cosmetic will be one of the things you must go through in order to realize that intention mentioned.

Did you know? The NPRA Malaysia or National Pharmaceutical Regulatory Agency was created in order to enforce quality control on pharmaceuticals in October, 1978. NPRA Malaysia was formerly known as National Pharmaceutical Control Bureau (NPCB) and this agency was recognized internationally by the World Health Organisation (WHO) in 1996. What exactly NPRA Malaysia was being recognized for by WHO? The equipment and facilities were built to satisfy the standards for research and quality control practices, therefore the NPRA Malaysia was acknowledged as “WHO Collaborating Centre for Regulatory Regulation of Pharmaceuticals.”

What are the Roles and Duties of NPRA Malaysia?

The National Pharmaceuticals Regulatory Authority (NPRA) of Malaysia is responsible for enforcing the drug registration/cosmetic confirmation process in Malaysia through scientific data assessment, laboratory review, testing, and information acquired from global organisations. In addition to performing medicinal, microbiological, and pharmacological medication and cosmetic testing to determine the quality, effectiveness, and safety of those drugs, a regulatory scheme for pharmaceutical product quality and the implementation of a licensing system for drug producers, importers, distributors, and wholesalers are being considered as well as a clinical trial licensing scheme.

What Type of Products that need to be registered with NPRA for Them to be Allowed to Sell?

• Controlled poison or controlled medication refers to any pharmaceutical item that contains scheduled poisons.
• Over The Counter (OTC) product or non-prescription medicine such as medicated plaster, Antiseptics and disinfectants formulated for human use, human-use medical agents (in vivo), supplemental diets.
• Traditional goods such as Homeopathic drugs, medicines from Ayurvedics, plaster-medicated, herbaceous teas, dietary pills, for example, spirulina, chlorella, royal jelly, bee pollen, noni juice, aloe vera juice, chicken extract, etc.
• Veterinary products in the form of oral solution, oral suspension, and emulsion such as granules, paste, water soluble powder, injectable, powder for injection, oral powders, capsule, tablet, topical ophtalmic and otic products.

Here are the Procedures which you must follow to Register Pharmaceutical Products

First thing you would need to do before beginning your registration is to apply for a Quest membership and purchase a USB Token before you can proceed with registration. Once you have received the USB Token, you will be able to enter the registration site and proceed with online submission.

The followings are what you must do to begin the registration;
1. Go to NPRA website (www.npra.gov.my) > Industry > First Time User > Register USB Token.
2. Apply for QUEST Membership. Requirements:
   i. Company Registration Form
   ii. Company Authorization Letter
   iii. Photocopy of I/C
3. Purchase a USB Token from MSC Trustgate once your Quest membership has been approved.
4. Login Quest to submit product registration application.
5. Submit data requested.
6. Correspond with an NPRA officer if additional data is needed.
7. Products tabled to DCA meeting.

What Kind of Products that do not have to be registered to NPRA to be able to be sold?

1. Raw herbs- cut by pieces or dried ones.
2. Diagnostic agents or test kits for in vitro use.
3. Medical devices such as blood bags that contain anticoagulants, visco-elastic products for mechanical or physical protection of tissues during or after surgical procedures, non-medicated plasters, wound dressing materials which contain hydrogel, collagen, calcium alginate, disinfectants for equipment or devices, lubricants for gloves, condoms and endoscopes, care products for contact lens, copper IUDs, bone cement, and tissue adhesives.
4. Repellents for insects.
5. Body-building goods containing protein/whey/ soya bean.
6. Food.

Read this article if you are finding skincare distributor Malaysia.

References

• ASSAKINA, L. (2021, July 23). NPRA. Retrieved from NPRA