Urgent Changes Needed to Canadian OTC Drug Regulations

Companies interested in selling SPFs and other simple drugs in Canada are faced with an almost impossible task. We have estimated that to launch a single SPF product in Canada, it would cost approximately $170,000 in year one just for the regulatory and quality assurance work that must be done. These costs are above and beyond the cost of goods, marketing fees, slotting fees at retail, etc.

More difficult yet, these kinds of products must be imported under a specialized license, called a Drug Establishment License. These licenses have become extremely difficult to obtain and maintain if you are not a true drug manufacturer or importer. During the last year, companies needing to make any kind of changes to these licenses has started taking  250 days for Health Canada to approve them. This has been a breaking point for many companies.

We are hopeful that Health Canada will embrace a much simpler approach for these products. HC already has an outstanding infrastructure for Natural Health Products. These products are regulated, but do not require many of the onerous steps and costs needed for drugs. It is also very possible that simple drugs like SPFs could become regulated as cosmetics.