Where next? Geographic expansion: the regulatory perspective. Part 4: Canada
SummaryPart four of a four part series
In the final part of this blog series, Kimty Bui-Van of ProductLife Group considers how increasing regulatory harmony between regions is improving the prospects for companies looking to grow their global opportunity in the uppermost reaches of North America
Canada in close-up
As a member of the International Council for Harmonisation, Canada takes a regulatory approach familiar to most global companies. The approach is similar to Europe’s, although Health Canada has implemented certain country-specific regulations.
Canada requires that a physical entity (directly owned or otherwise) be in the country for a drug establishment licence. Companies that have experience with the European eCTD or even US submission requirements should find preparing an eCTD for Canada relatively straightforward. The United States and Canada have established a Regulatory Cooperation Council Pharmaceutical and Biological Products working group to enhance regulatory harmonisation between the two countries.
The pharmaceutical industry in Canada employs around 27,000 people directly and more than 100,000 people indirectly and is growing at a compound annual rate of 2.2%, according to government sources. Most pharma companies are clustered in Toronto, Montreal, and Vancouver.
Defining market characteristics
Among the Canada-specific regulatory requirements is the product monograph, which is akin to the EMA’s summary of product characteristics and which documents non-promotional information about a drug, including its properties, claims, indications, and conditions of use.
Health Canada introduced plain-language labelling requirements in 2014 to ensure that patient materials are easy to understand. Another consideration is a requirement to publish a product monograph and all labelling in both English and Canadian French, which differs slightly from European French.
Although it is not a legal requirement to have someone on the ground in Canada to handle submissions, local knowledge, the ability to liaise with the health authorities and have a one-on-one relationship with the client are invaluable.
As a straightforward and transparent market, Canada poses few specific regulatory complexities for companies. However, understanding the local environment and developing a rapport with the local authority are important to avoid delays to market given that, unlike in Europe, there is no predefined time limit in Canada for the question-and-answer review period.
Canada is the 10th-largest pharmaceutical market in the world. It has also been rated the best in the Group of Seven industrialised nations for cost-effective clinical trials and medical product testing. And it is a leader in biotechnology and vaccines.
Given its similarities to both the United States and Europe with regard to regulatory requirements, Canada raises few hurdles for companies—and presents many advantages – so we can expect to see more companies turning market interest into decisive action over the next year and beyond.
As with any new market opportunity, it is important that companies approach the regions covered in this blog series with their eyes open and the right advice at hand. As long as they have done sufficient groundwork, the business growth opportunities open to them could be substantial.
Kimty Bui-Van is head of regulatory affairs and pharmaceutical services at ProductLife Group.