22Jun

Possible Delays Ahead with Canadian Product Approvals

Plan for longer product approval wait times as Health Canada implements massive public service cutbacks that could impact the service delivery of key government agencies. Over the next three years Health Canada will lay off nearly 840 employees and experience a budget cut of $600 million.

With a possible service slowdown, a “do it right the first time” approach will be necessary to survive in the Canadian regulatory environment over the next few years. Any non-compliance issues hold the potential to cause delays in product lifecycle management, as the Government will have fewer resources available.

Canada already lags behind both Europe and the USA when it comes to approval times for new drugs: Approximately 86% of new drugs are approved in the USA before Canada. With massive Health Canada layoffs, regulatory leadtimes could worsen.

In addition, a slower importation process is expected over the next few years, as the Canada Border Services Agency (CBSA) plans to lay off 1,137 employees. The CBSA performs the crucial activities for importers bringing products into Canada including: accounting for shipments, examining shipments, registering shipments, releasing of shipments, reporting shipments and storing shipments. To avoid expensive product retains at the border, it will become even more crucial for companies to ensure their products comply with all Canadian Regulations.

What to Do:

  1. Anticipate longer lead times for products requiring pre-approval.
  2. Contact FPR early in your new product development projects to get labeling correct and approvals completed.

If you have any questions about how to prepare for expected regulatory delays, please contact us at 905-271-2709.