Update on Health Canada and FDA Collaboration

Last summer, we reported that Health Canada and the FDA were beginning a series of meetings to discuss how Canada and the U.S. could work together to make their drug approval processes more efficient. At that time, they announced the formation of a council (it’s called the Canada-US Regulatory Cooperation Council, or RCC) to look at the differences in each country’s regulations, including the review processes that govern the approval of new medicines, and try to reach agreement on a single approach.  They have conducted a number of meetings on this subject, and plan to continue meeting over the coming year. Here are some of the more important initiatives that the RCC are now working on:

One Submission for Both Countries

There are a number of other initiatives underway with the objective of minimizing delays in bringing healthcare products to the marketplace.  One of these is to develop a common electronic gateway through which pharmaceutical companies can submit the information required to gain market approval for a new drug to both Health Canada and the FDA simultaneously. These submissions contain a huge amount of documentation, so allowing companies to prepare a single submission for both countries is a big step forward.

Sharing Inspection Findings

In order to ensure that the drugs we consume are manufactured in a safe way, Health Canada and the FDA conduct inspections at manufacturing sites.  In order to better utilise their resources and avoid duplication of effort, they will start to share more information on the outcome of these inspections.  They are also going to explore the possibility of performing joint inspections of manufacturing sites outside of North America.

 “Increased collaboration between regulatory agencies in Canada and the U.S. will…….minimize the delays in bringing health and personal care products to the marketplace, thereby expanding consumer choice without compromising the safety, efficacy and quality of products”

The efforts that Health Canada and the FDA are making to improve the drug approval process are of importance to all Canadians and Americans, and we will continue to provide you with updates as more information becomes available.