Accepted Abstracts: Pharmaceut Reg Affairs
Natural Health Products are regulated in Canada as a sub-set of drug regulations. The Natural Health Products Directorate was created in 2004 to appropriately address the issues facing natural health products in a way food or drug regulations could not. Under this directorate, vitamins, minerals, herbs, fatty acids, amino acids and homeopathic products are regulated according to standards designed specifically for them. The directorate has the mandate to ensure natural health products are safe, efficacious, and made correctly according to GMPs. This protects the Canadian public from dangerous and/or misleading products and consumers now have confidence that the products they are buying are safe and effective for their families. Industry is gradually accepting and embracing these regulations as they have benefits to all involved. Companies now can legally and confidently make some very strong health claims on natural health products; in fact natural health products must make health claims in Canada, these range from claims such as ?an antioxidant? to ?help to reduce serum triglycerides.? Companies are now free of competitors who dilute the industry with deceptive products. The process of registering products has greatly improved since inception and is now much more streamlined. Licenses take between 10 and 180 days depending on the complexity of the formula and desired claims. Currently, over 60,000 product licences and well over 1,000 site licences have been granted. These regulations definitely require an extra step before bringing your product to market; however the global legitimacy it brings to your product, claims and company as a whole, is well warranted.
Lionel Pasen is the veteran of the natural health products industry in Canada since 50 years. He is a founding member of the Canadian Health Food Association (CHFA), Canada?s largest national trade association for the natural products and organics industry. He was the former Chairman of the Oversight Committee on Regulatory Affairs and is regularly in contact with the Natural Health Products Directorate (NHPD) of Health Canada. With experience and contacts in the industry, he is a consultant in completing product licence applications and finding distributors/manufacturers to move your product successfully in Canada.
Pharmaceutical Regulatory Affairs: Open Access received 471 citations as per Google Scholar report