Natural Product Number NPN Health Canada Application Process Unlocked

In Canada, the regulatory frameworks for Natural Health Products (NHPs) and drugs differ significantly, despite both being products aimed at maintaining or improving health. These differences exist in areas such as product classification, approval process, manufacturing requirements, and post-market surveillance. NHPs: Classified as a subset of drugs under the Natural Health Products Regulations but are treated separately due to their ingredients. NHPs include vitamins, minerals, herbal remedies, homeopathic medicines, probiotics, and traditional medicines. Drugs: include prescription medications, over-the-counter (OTC) drugs, and biologics, regulated under the Food and Drugs Act and the Food and Drug Regulations. Drugs are typically synthetic or chemically derived substances used for the diagnosis, treatment, mitigation, or prevention of diseases. The Natural and Non-prescription Health Products Directorate (NNHPD) oversees their safety, efficacy, and quality. NNHPD focuses on ensuring NHPs meet standards suitable for lower-risk products. Health Canada’s Therapeutic Products Directorate (TPD), which assesses the safety, efficacy, and quality of prescription and non-prescription drugs, ensuring they meet more stringent requirements. Manufacturers or brand owners must apply for a Natural Product Number (NPN), which requires submitting product-specific information such as the ingredients, health claims, and recommended usage. The level of evidence required for approval depends on the risk level of the product, with traditional usage often accepted as proof of efficacy. Before a drug can be sold in Canada, manufacturers must submit a  drug application form such as for OTC drugs, a New Drug Submission (NDS) or an Abbreviated New Drug Submission (ANDS) for generic drugs and obtain a drug identification number (DIN). This requires providing extensive clinical trial data to demonstrate safety and efficacy. New Drugs undergo a rigorous pre-market evaluation, often taking years to approve. However, OTC drugs are a faster approval process taking several months.  NHPs typically contain naturally occurring substances, such as vitamins, minerals, plant extracts, or traditional remedies. They can be synthetic but are naturally derived synthetic duplicate (eg. ascorbic acid).  These ingredients are generally lower in risk and are subject to less rigorous evidence requirements than drugs.  Drug  usually contain synthetic or highly purified chemical compounds. Drug ingredients must be proven safe and effective through substantial scientific and clinical evidence, with higher-risk ingredients requiring stricter evaluations. In Canada, various NHP activities such as importing, manufacturing, packaging and labelling requires a site license whereas with drugs, the same activities but also including testing, distribution, wholesaling requires an establishment license. The health claims made for NHPs are of three types, structure-function, therapeutic and preventative.  They are generally limited to lower-risk, general health maintenance claims, such as promoting overall health or supporting specific bodily functions (e.g., immune support). Claims must be supported by traditional use or limited scientific evidence. Health claims for drugs can be much broader, including specific disease treatment or prevention claims. These claims must be supported by robust scientific data from clinical trials demonstrating efficacy and safety. NHPs are, for the most part, available publicly in various retail outlets and health food stores whereas drugs are available in pharmacies or behind the counter for prescription and some higher risk non-prescription drugs.