Major Changes Coming to the Regulation of OTCs in Canada

Please be advised that Health Canada will be implementing significant changes surrounding the review of non-prescription drugs and disinfectants.

Our trade association, the CCTFA, has announced that effective July 1, 2013, Health Canada staff who review non-prescription drugs and disinfectants will move from the Drugs Directorate to  the Natural Health Products Directorate (NHPD). While on the surface this might seem strange (these drugs are not “natural”!) it signals a very important change in how the Canadian government wishes to regulate these products. The NHPD has revolutionized the review of Natural Health Products, eliminating backlogs and expediting the review of new submissions.

Impacts on Industry

The objective of this change is to apply a consistent approach to similar risk-based products using practices that are applied to natural health products (NHP’s). These changes will allow for “cosmetic-like” drugs and NHP’s to be reviewed under NHP practices….which are faster and often simpler than drugs. This provides an opportunity to resolve some major issues that industry has been stricken with over the past several years. This is a very positive change and one we believe is only the beginning of more changes.

If you have held off launching SPF products and other OTCs in Canada because of our onerous requirements, this may be the time to have a fresh look.

Regulations

Health Canada will not be making any regulatory amendments to facilitate these changes. All regulatory requirements that regulate OTCs will continue to be reviewed in accordance with the Food and Drug Regulations. Associated expenses are determined under the Fees in Respect of Drugs and Medical Devices Regulations. As for NHP’s, there will be no change in the regulations or policies applied and the New Approach to Natural Health Products still applies. No fees will be charged for the review of NHP applications.

Sunscreen Monograph

Health Canada has reconfirmed that the Therapeutic Products Directorate (TPD) and the NHPD will accept submission applications referencing either the 2006 Sunburn Protectant Monograph or the draft revised Sunscreen Monograph (2012). This change is especially advantageous for those products that use nano titanium or zinc as actives. Health Canada has requested that sponsors include a cover letter specifically identifying which monograph has been used to support the submission.

Overall, these changes are expected to alleviate restraints that previously weighed heavily on the submissions of OTC’s. Focal Point Research Inc. is a leading consulting company with expertise ranging from cosmetics to natural health products. Let our associates strategically guide your company to compliance. Contact one of our experts at (905) 271-2709. We’d be happy to assist you with your product needs.