Canadian Generic Pharmaceutical Association

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Canadian Generic Pharmaceutical Association

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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.

10/16/2026

Health Canada’s backlog of generic drug submissions has grown significantly over the past year, increasing from 117 submissions in September 2025 to 250 as of June 2026.

At the same time, Health Canada met its 180-day review target for just 72% of generic drug reviews in 2025–26, down from 84% the previous year and 100% in multiple recent years.

The consequences of these delays extend beyond the regulatory process. When generic drug reviews take longer, lower-cost medicines can reach the Canadian market later, making it harder for manufacturers to plan product launches and delaying potential savings for public and private drug plans.

Health Canada has attributed the growing backlog in part to an unprecedented increase in the volume and complexity of generic drug submissions.

CGPA supports measures to prioritize submissions where they can provide the greatest benefit to Canadians. But prioritization cannot address the underlying capacity challenge.

Health Canada needs sufficient review resources to keep pace with its workload and provide timely, predictable generic drug reviews.

10/09/2026

When a medicine loses patent protection, the arrival of its first generic competitors can have a significant impact on drug costs.

These 'first-wave' generics are the first generic versions to enter the market for a medicine that doesn't yet have generic competition. And once that happens, the Tiered Pricing Framework rewards additional entrants (a second, then a third) with further price reductions.

That means timely reviews of first-wave generics can translate directly into savings for Canada’s health-care system.

There are currently 70 first-wave generic medicines or combinations under review by Health Canada. Canadian hospital and retail payers spend approximately $4.7 billion annually on their brand-name versions, and CGPA estimates that timely approval and market entry of these generics could generate approximately $2.2 billion in savings in their first year on the market.

That’s why CGPA supports prioritizing first-wave generic submissions when review capacity is constrained.

But prioritization is only part of the solution. Health Canada also needs sufficient review capacity to ensure Canadians can benefit from lower-cost generic competition in a timely and predictable way.

09/30/2026

Health Canada’s backlog of generic drug submissions has more than doubled, from 117 submissions in September 2025 to 250 as of June 2026.

Prioritizing certain submissions can help ensure existing resources are directed toward medicines that can provide the greatest benefit to Canadians. But prioritization doesn’t increase the number of submissions Health Canada can review.

That requires additional capacity.

Health Canada has told generic manufacturers and CGPA that it would hire 40 additional review staff; as of June, 12 had been hired on two-year terms. But CGPA estimates that at least 100 additional full-time generic review staff are needed to eliminate the backlog and restore timely and predictable reviews.

And the need is particularly pressing, because Health Canada faces a growing workload. The department received 1,052 generic drug submissions in 2025–26, a 55% increase over the previous five-year average.

Investing in sufficient review capacity can help lower-cost generic medicines reach Canadians sooner, give manufacturers greater predictability and ensure public and private drug plans can realize potential savings in a timely manner.

Prioritization may help manage the queue, but only sufficient review capacity will adequately address it.

09/21/2026

There are currently 70 first-wave generic medicines or combinations under review by Health Canada, representing billions of dollars in potential savings for Canada’s health-care system.

Canadian hospital and retail payers currently spend approximately $4.7 billion a year on the brand-name versions of these medicines, and CGPA estimates that timely approval and market entry of their generic competitors could generate approximately $2.2 billion in savings for payers in their first year on the market, after patent expiry.

But Health Canada’s growing backlog of generic drug submissions means lower-cost medicines are reaching Canadians later than they otherwise could.

Prioritizing key submissions can help, but prioritization alone won’t solve the underlying problem.

To ensure timely access to billions of dollars in potential savings for Canada’s health-care system, Health Canada needs sufficient review capacity to provide timely and predictable generic drug reviews.

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/

Address

4100 Yonge Street, Suite 501
Toronto, ON
M2P2B5

Telephone

+14162232333

Website

http://www.canadiangenerics.ca/

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