Canadian Generic Pharmaceutical Association

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Canadian Generic Pharmaceutical Association

Representing manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of active pharmaceutical chemicals.

The CGPA represents the Canadian-based generic pharmaceutical industry: a dynamic group of companies which specialize in the production of high quality, affordable generic drugs, fine chemicals and new chemical entities.

09/04/2026

A reliable drug review system would bring affordable medicines to Canadians faster.

And while that's a worthy goal in and of itself, the benefits of a predictable system extend even further.

Unpredictable review timelines mean companies face greater uncertainty about where and when to invest, making it harder to secure new production mandates and strengthen Canada's domestic pharmaceutical capacity.

A reliable, predictable system would incentivize generic drug manufacturers to invest in Canadian research, manufacturing and product launches.

At a time when supply chains remain vulnerable and geopolitical uncertainty continues to grow, Canada needs a regulatory system that supports both timely access to medicines and long-term investment.

A predictable, well-resourced drug review process is essential to strengthening Canada's pharmaceutical resilience and ensuring Canadians have reliable access to the medicines they need.

08/28/2026

As of August 25, 2026, manufacturers and vendors can use the DIRECT (Drug Intake, Review, Evaluation, Contracts, Transactions) portal to easily create, manage and track submissions to the Ontario Ministry of Health.

DIRECT allows you to quickly access relevant ministry submission guidelines, view current announcements, and maintain your contact information. The portal supports a wide variety of submission types and products, including single source drug products, multiple source drug products, biosimilars, nutrition products, and more.

Guideline‑driven, data‑entry forms ask only the questions needed for your specific submission, helping reduce incomplete submissions. DIRECT also allows you to submit additional information in cases of incomplete submissions and request certain changes to existing products.

DIRECT submissions benefit from an extended deadline where DIRECT new multiple source product submissions are accepted until 11:59 p.m. Eastern Time (ET) on the published deadline date. The 3:00 p.m. deadline remains in effect for new multiple source product submissions sent by email. Deadline dates are available on the Drug Submissions webpage: https://www.ontario.ca/page/drug-submissions

08/20/2026

The arrival of generic semaglutide is renewing the conversation about switching from brand-name medicines to lower-cost generics.

While some patients may be hesitant to make the change, the evidence is clear:

Generic medicines approved by Health Canada are just as safe and effective as their brand-name counterparts. They must meet the same rigorous standards for quality, safety and efficacy before they can be approved.

There is a substantial difference between generics and brand name drugs, but it isn't how well they work. It's how much they cost.

When patients, providers and drug plans embrace lower-cost generic medicines, everyone benefits. Canadians gain access to the same trusted treatments, while public and private drug plans can redirect valuable healthcare dollars to other priorities.

Generics have been helping Canadians access safe, effective and affordable medicines for decades. Generic semaglutide is simply the latest example of how competition can make healthcare more sustainable for everyone.

You can read more here: https://www.benefitsandpensionsmonitor.com/benefits/group-health/generic-semaglutide-sparks-fresh-debate-over-substitution/393874?hsmemberId=22290246&tu=&utm_campaign=&utm_medium=20260716&_hsenc=p2ANqtz--3ug9SysaCArz95z3yJS5SvfTqH4d_ncEkMnZFmBYmGa-7nfQWc8ZLlFq-vNs4-JT4uoDq_BWD87p3PftZ1Fh-QjpDhg&_hsmi=428708421&utm_content=&utm_source=

08/14/2026

Generics Bulletin Highlights the Positive Impact of Supreme Court Patent Ruling

The Supreme Court of Canada’s recent ruling affirming that methods of medical treatment cannot be patented continues to draw attention from the pharmaceutical industry.

In a new article, Generics Bulletin highlights CGPA’s response to the decision and its importance for physicians, patients and Canada’s generic and biosimilar medicines industry.

AS CGPA President Jim Keon says in the article, “By affirming that methods of medical treatment are not patentable, the Supreme Court has preserved physicians’ freedom to exercise their clinical judgment without interference from patent monopolies and has taken a stand against patent evergreening tactics that delay the entry of more affordable generic and biosimilar medicines.”

Read Generics Bulletin’s full coverage of the ruling and CGPA’s response:

https://insights.citeline.com/generics-bulletin/legalandip/cgpa-accentuates-the-positive-after-canadian-supreme-court-patent-ruling-ZGYAPOVW4JATTP4X2QDWFXWKI4/?utm_campaign=Insights%20-%20Generics%20Bulletin%20-%20Daily&utm_source=Eloqua&utm_medium=Email&utm_content=SPARC%20-%20Generics%20Bulletin%20-%20Daily%20-%20FREE&utm_campaignID=&elqcst=272&elqcsid=125

08/06/2026

Jim Keon, President of CGPA, speaks out on behalf of member companies in a must-read Globe and Mail article published yesterday.

In the coverage, Globe reporter Chris Hannay explores the issues surrounding the doubling of Health Canada’s backlog of generic drug applications.

Increasing delays are negatively effecting patients, insurers and generic pharmaceutical companies. Why are the delays increasing so rapidly? What’s being done about it? Why is it not enough?

Read the Globe and Mail article to learn more about the costly delays: https://www.theglobeandmail.com/business/economy/article-health-canada-backlog-generic-drugs-pharmaceuticals/

08/04/2026

The Supreme Court of Canada has reaffirmed a long-standing principle: methods of medical treatment cannot be patented in Canada.

As an active intervener in this case, CGPA welcomes the Court's decision to protect physicians' clinical judgment, take a stand against patent evergreening and support timely access to more affordable medicines for patients and payers.

"This ruling is a win that supports the sustainability of Canada's healthcare system and patient access to cost-saving generic and biosimilar medicines," said CGPA President Jim Keon.

Read our full news release to learn more about what this decision means for patients, healthcare providers and Canada's pharmaceutical system.

https://canadiangenerics.ca/supreme-court-reaffirms-that-methods-of-medical-treatment-are-not-patentable-in-canada/

07/31/2026

The Canadian Generic Pharmaceutical Association welcomes the federal Pharmaceutical and Life Sciences Sector Task Force report and many of its recommendations to strengthen Canada's pharmaceutical sector.

But as the government looks towards implementation, it's essential that generic and biosimilar manufacturers have seats at the table.

"A pharmaceutical and life sciences strategy cannot be effective if it does not include the manufacturers of the medicines that account for more than 80 percent of prescriptions dispensed in Canada and companies that operate most of this country's pharmaceutical manufacturing capacity," said CGPA President Jim Keon.

Read our full news release to learn more about why Canada's generic and biosimilar industries must be part of the next phase of this work.

https://canadiangenerics.ca/cgpa-calls-for-participation-of-generic-and-biosimilar-medicines-industries-in-implementation-of-pharmaceutical-and-life-sciences-task-force-report-recommendations/

07/22/2026

The Globe and Mail featured CGPA President Jim Keon today on the importance of preserving tariff-free trade in generic medicines.

Recent announcements in the United States have renewed the conversation around tariffs on generic medicines. While details of the proposed policy have yet to be released, one thing is clear:

Canada and the United States have spent decades building an integrated pharmaceutical supply chain that benefits patients in both countries.

As Jim told The Globe and Mail, "Trade barriers on essential medicines are not in the interests of patients, healthcare systems or either country's long-term health security."

Maintaining tariff-free trade helps preserve a secure, affordable and reliable supply of generic medicines across North America.

07/17/2026

Health Canada has a growing backlog of generic drugs submitted for review.

And the longer reviews take, the longer Canadians pay more than they need to for medicines that could already be available.

Postponing cost-saving drug competition means Canadians wait longer for more affordable treatment options, while public and private drug plans lose out on savings that could be used to fund innovative new therapies.

A timely, predictable drug review system isn't just about efficiency. It's about helping Canadians access affordable medicines sooner while strengthening the sustainability of our healthcare system.

Reducing Health Canada's review backlog will help deliver cost-saving medicines to patients faster and unlock savings that can be reinvested where they're needed most.

07/10/2026

Generic medicines now account for more than 80% of all prescriptions filled in Canada, up from 73% in 2020.

That's good news for patients and healthcare systems alike.

Generic medicines provide the same quality, safety and effectiveness as their brand-name counterparts while delivering significant savings for public and private drug plans.

As more Canadians rely on generic medicines, it's more important than ever to ensure they can access them quickly and reliably.

Generic medicines are already the backbone of Canada's prescription drug system.

Keeping them accessible helps make our healthcare system more affordable and sustainable for everyone.

Address

4100 Yonge Street, Suite 501
Toronto, ON
M2P2B5

Telephone

+14162232333

Website

http://www.canadiangenerics.ca/

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