Minister of Health Marjorie Michel says one way to speed up drug approval timelines is earlier screening of applications.Adrian Wyld/The Canadian Press
The federal government is committed to speeding up drug approval timelines as part of Prime Minister Mark Carney’s drive to improve efficiency and cut red tape, Health Minister Marjorie Michel said in an interview.
The Globe and Mail reported this week on new data that showed Health Canada is increasingly failing to review generic drug applications within its 180-day target, meaning cheaper pharmaceuticals are taking longer to get to market.
That is on top of Canada’s historically slow timelines for all drugs, which rank among the longest in developed countries.
Ms. Michel said that, while safety can’t be compromised, it is clear there are ways to make the approval process more efficient, and she has asked her department to report to her regularly on timelines.
“It’s a priority for me,” she said in an interview on Tuesday.
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The Liberals promised in the spring election to “significantly reduce” wait times for pharmaceuticals, which it acknowledged were longer than in other Group of Seven countries.
“By cutting red tape without compromising on safety we will cut this timeline while maintaining all relevant safety standards, supporting our research community and delivering life-saving medicines more quickly,” the Liberal campaign platform said.
Health Canada has said one reason for delays in generics applications is incomplete or inadequate documentation from pharmaceutical companies.
Data reported by The Globe this week showed that, in the 2024-25 fiscal year, 70 per cent of applications received a ruling in the final week before the 180-day target. In about three-quarters of those cases, the applications were rejected and Health Canada requested further information.
But 90 per cent of applications were ultimately approved, leading the Canadian Generic Pharmaceutical Association, which represents generic drug makers, to argue that the early rejections are more a sign of files being picked up too late and not because of underlying deficiencies with the drugs.
Ms. Michel said one relatively straightforward solution is earlier screening of applications.
“Where I can push is, yeah, we cannot take eight months to let them know” when there are paperwork issues, she said. “If work has to be done, then the person needs to know as soon as possible.”
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Another area of improvement the minister identified is better collaboration with regulators in other countries.
Most large pharmaceutical companies operate globally and have to work with regulators in other countries. They often question why Canadian regulators take longer than their European peers.
“I would say also that what I’m encouraging my department to do a lot is to lean on approvals done by like-minded partners,” Ms. Michel said.
“Because if a drug is approved somewhere, we trust that [they] have the same regulations that we have or quite the same, well, maybe it can speed up the process.”
Not all parts of the drug approval process are under federal control. The final stage of the pathway is when drug makers go to the pan-Canadian Pharmaceutical Alliance to negotiate pricing deals with all federal, provincial and territorial public insurance plans. In those discussions, Ottawa is one of 14 seats at the table.
Ms. Michel said she is working with provincial counterparts on this issue, although it is one of many urgent health problems the system is facing.
“You know, they are overwhelmed, maybe with primary care,” she said of the provinces, adding that it is her role to bring everyone to the table and “see how we can, you know, speed the process.”
She said one of Canada’s major strengths is its research sector. She said that will continue to be a focus and pointed to an announcement of $1.3-billion in research funding she and Industry Minister Mélanie Joly made in July.
“We have to deliver on this,” she said.