National Pharmaceutical Regulatory Agency of Malaysia (NPRA Malaysia) was founded in October 1978 to impose quality control on medications. It was internationally recognized by the World Health Organization (WHO) in 1996.
The NPRA has been entrusted with ensuring the quality, efficacy, and safety of pharmaceuticals via the use of the registration and licensing system. This is performed by performing thorough laboratory testing on all products before their release and assessing the data gained from scientific investigations.
Which categories of products must be registered with the NPRA?
A controlled poison or controlled medication is any pharmaceutical product containing toxins on a schedule. These words have the same meaning.
Over-the-counter (OTC) products include items such as medicated plaster, antiseptics and disinfectants suited for human use, human-use medicinal agents (in vivo), and dietary supplements.
Homeopathic medications, Ayurvedic medicines, plaster-medicated drinks and tablets, herbal teas, and nutritional supplements such as spirulina, royal jelly, bee pollen, noni juice, aloe vera juice, chicken extract, etc.
Veterinary products in the form of oral solution, oral suspension, and emulsion, including granules, paste, water-soluble powder, injectable, injection powder, oral powders, capsules, tablets, and topical medicines.
How does the NPRA product registration process work?
Before you can continue with the NPRA product registration, you must first apply for a Quest membership and then purchase a USB Token. Then and only then can you continue with registration. After you have gotten the USB Token and signed in to the registration site, you will be able to proceed with the online submission procedure.
To start the registration procedure, you must complete the following steps:
Under the title, First Time User, go to the NPRA website (www.npra.gov.my) and click on the Industry area. Register USB Token.
Apply to become a member of QUEST.
Form for Company Registration, Authorization Letter for Company Registration, Photocopy of I/C
After your membership application has been accepted, you will be able to purchase a USB Token from the MSC Trustgate.
Enter your login details into Quest to submit your application for product registration.
Submit data requested.
If further information is needed, you should initiate a discussion with an NPRA officer.
Is NPRA Cosmetic Registration Necessary?
The voluntarily agreed Halal standards and regulations include all aspects of cosmetics, including production, ingredient acquisition, manufacturing process, storage, packaging, and shipping. In other words, they are exhaustive. Consequently, registering cosmetic items in Malaysia might be a tedious endeavor. To inform the Malaysian government about a cosmetic product, a locally created company, also known as a License Holder or Cosmetic Notification Holder (CNH), must be able to serve as a single point of contact on behalf of the owner of an international brand.
What is NPRA Quest 3?
The Quest 3+ Submission System is a centralized regulatory control system for the Malaysian pharmaceutical industry. Its objective is to facilitate safe online transactions for product license holders, as well as producers, importers, re-packagers, and distributors. Among the transactions that may occur are registration, variations, and re-registration, as well as restricted modifications to the stored data.
This information may comprise, among other things, addresses of industrial facilities. Other transactions might include licensing and surveillance. For a user to do such transactions, you must first register membership and then acquire a USB token that contains a User Digital Certificate. After the token has been successfully installed, the user will be able to conduct transactions inside QUEST 3+.
For product registration, only web-based, online submissions through QUEST on the website http://www.bpfk.gov.my will be accepted.