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.
Pharmaceutical Product Registration (NPRA)
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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
- Herbaceous teas
- Dietary pills, for example, Spirulina, Chlorella, Royal Jelly, Bee Pollen, Noni juice, Aloe Vera juice, Chicken Extract, etc.