We provide strategic consultancy and advisory on product registration and assist our clients to interact with the National Pharmaceutical Regulatory Agency, NPRA (formerly known as National Pharmaceutical Control Bureau) for a wide range of product applications including pharmaceuticals, cosmetics, OTC, and complementary medicines.
Services
Pharmaceutical Product Registration (NPRA)
Experienced Regulatory
Affairs Consultants At Your Service
Under the Regulation, 2 of Control of Drugs and Cosmetics Regulations (CDCR) 1984, product means:
- A drug in a dosage unit or otherwise, for use wholly or mainly by being administered to one or more human beings or animals for a medicinal purpose, or
- A drug to be used as an ingredient of a preparation for a medicinal purpose.
Any above-mentioned product shall be registered with National Pharmaceutical Regulatory Agency (NPRA). The products include, but not limited to the following:
- Pharmaceutical products containing scheduled poisons.
- Pharmaceutical products containing non-scheduled poisons.
- Health Supplement Products.
Which Products 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)
These include below:
- Medicated plaster
- Antiseptic/ Disinfectants designed for human body use
- Human-use medical agents (in vivo)
- Supplemental diet, e.g., Chitosan, Probiotics
- Traditional goods
- 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.
NPRA Product Registration
Health Supplement Registration
We offer advisory, consultancy and monitoring services for registration of natural product in Malaysia with National Pharmaceutical Regulatory Agency (NPRA) via Quest3+.
Products in this category include vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bio-active substances.
NPRA Product Registration
Natural Product Registration
We offer advisory, consultancy and monitoring services for registration of natural product in Malaysia with National Pharmaceutical Regulatory Agency (NPRA) via Quest3+.
Products in this category include traditional Chinese medicine (formulary products), herbal products, medicated oil, analgesic cream.
NPRA Product Registration
Cosmetic Notification
We assist cosmetic manufacturer or distributor to register their cosmetic product in Malaysia with National Pharmaceutical Regulatory Agency (NPRA) via Quest3+.
Products in this category include skin whitening product, perfume, face mask, hair-care product, make-up powder, sunbathing product, anti-wrinkle product, and so on.
NPRA Product Registration
Product Classification & Food Label
Product Classification application for Food Drug Inter-phase (FDI) products with NPRA. We also assist manufacturer or distributor to apply for Food Label Screening and Advisory with Food Safety and Quality Division (FSQD), Health Ministry of Malaysia.
NPRA Product Registration
Post-registration Amendments
Post registration amendments for example, major and minor variation applications, change of manufacturing site, change of product registration holder.
NPRA Product Registration
GMP consultation
We provide advisory & consultancy services for new factory to comply with the GMP requirements set forth by NPRA. We also assist in layout plan design and provide training to fulfill subsequent audit requirements by NPRA.