True. The joint review mechanism proposed is fine IMO & sharing info between regulators is good. Canada doesn't have the capacity to do foreign inspections at scale.
But that's not equivalent to rubber-stamping new drug approvals thru the 'general deeming' pathway envisioned in the proposal tho.
But that's not equivalent to rubber-stamping new drug approvals thru the 'general deeming' pathway envisioned in the proposal tho.
January 19, 2026 at 3:25 PM
True. The joint review mechanism proposed is fine IMO & sharing info between regulators is good. Canada doesn't have the capacity to do foreign inspections at scale.
But that's not equivalent to rubber-stamping new drug approvals thru the 'general deeming' pathway envisioned in the proposal tho.
But that's not equivalent to rubber-stamping new drug approvals thru the 'general deeming' pathway envisioned in the proposal tho.
If you are concerned about this proposal, you can find its details and comment directly on its text via this link:L
gazette.gc.ca/rp-pr/p1/202...
The deadline to weigh in is Feb 28 @ 11:59 pm ET.
gazette.gc.ca/rp-pr/p1/202...
The deadline to weigh in is Feb 28 @ 11:59 pm ET.
Canada Gazette, Part 1, Volume 159, Number 51: Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs
December 20, 2025, Part 1, Volume 159, Number 51, Canada Gazette
gazette.gc.ca
January 19, 2026 at 3:05 PM
If you are concerned about this proposal, you can find its details and comment directly on its text via this link:L
gazette.gc.ca/rp-pr/p1/202...
The deadline to weigh in is Feb 28 @ 11:59 pm ET.
gazette.gc.ca/rp-pr/p1/202...
The deadline to weigh in is Feb 28 @ 11:59 pm ET.
One thing I can tell you for certain is that at least some scientists inside Health Canada are alarmed by this proposal.
And given that it's part of the GoC's 'red tape initiative', I'm very worried that this mechanism will be used to justify job cuts to Health Canada's core scientific staff.
And given that it's part of the GoC's 'red tape initiative', I'm very worried that this mechanism will be used to justify job cuts to Health Canada's core scientific staff.
January 19, 2026 at 3:05 PM
One thing I can tell you for certain is that at least some scientists inside Health Canada are alarmed by this proposal.
And given that it's part of the GoC's 'red tape initiative', I'm very worried that this mechanism will be used to justify job cuts to Health Canada's core scientific staff.
And given that it's part of the GoC's 'red tape initiative', I'm very worried that this mechanism will be used to justify job cuts to Health Canada's core scientific staff.
It's impossible to know what the intent of this proposal is unless GoC is more transparent about the list of eligible drugs and foreign regulators they plan to include within its scope.
January 19, 2026 at 3:05 PM
It's impossible to know what the intent of this proposal is unless GoC is more transparent about the list of eligible drugs and foreign regulators they plan to include within its scope.
Instead, I worry that this kind of process will be used by sponsors of new drugs that have been fast tracked in other countries, such as #aducanumab (often on the basis of surrogate endpoints) and have limited evidence of effectiveness but high prices.
January 19, 2026 at 3:05 PM
Instead, I worry that this kind of process will be used by sponsors of new drugs that have been fast tracked in other countries, such as #aducanumab (often on the basis of surrogate endpoints) and have limited evidence of effectiveness but high prices.
My theory, tho, is that those + other products aren't here because of our relatively small market size and disinterest from sponsors.
I doubt, in other words, that this reliance procedure will attract those manufacturers to Canada.
I doubt, in other words, that this reliance procedure will attract those manufacturers to Canada.
January 19, 2026 at 3:05 PM
My theory, tho, is that those + other products aren't here because of our relatively small market size and disinterest from sponsors.
I doubt, in other words, that this reliance procedure will attract those manufacturers to Canada.
I doubt, in other words, that this reliance procedure will attract those manufacturers to Canada.
I agree those medicines are needed in Canada as @healthlawadamh.bsky.social & co explain here:
www.cmaj.ca/content/195/...
www.cmaj.ca/content/195/...
Time for Canada to align with global innovations in treatment for tuberculosis
KEY POINTS
Despite serious disruptions to tuberculosis (TB) programs during the COVID-19 pandemic, including in Canada,[1][1] the past few years have also seen global advances in TB treatment. Novel d...
www.cmaj.ca
January 19, 2026 at 3:05 PM
I agree those medicines are needed in Canada as @healthlawadamh.bsky.social & co explain here:
www.cmaj.ca/content/195/...
www.cmaj.ca/content/195/...
How you view this proposal to rubber-stamp foreign decisions all depends on which kind of cases you are worried about.
As @healthlawadamh.bsky.social points out in this story in @theglobeandmail.com it *could* help effective #TB drugs to finally reach Canada
www.theglobeandmail.com/canada/artic...
As @healthlawadamh.bsky.social points out in this story in @theglobeandmail.com it *could* help effective #TB drugs to finally reach Canada
www.theglobeandmail.com/canada/artic...
Health Canada considering using decisions of foreign regulators for some drug approvals
Neither Health Minister’s office nor federal regulator ruled out including U.S. FDA on forthcoming list
www.theglobeandmail.com
January 19, 2026 at 3:05 PM
How you view this proposal to rubber-stamp foreign decisions all depends on which kind of cases you are worried about.
As @healthlawadamh.bsky.social points out in this story in @theglobeandmail.com it *could* help effective #TB drugs to finally reach Canada
www.theglobeandmail.com/canada/artic...
As @healthlawadamh.bsky.social points out in this story in @theglobeandmail.com it *could* help effective #TB drugs to finally reach Canada
www.theglobeandmail.com/canada/artic...
I also explain how this mechanism, if in place in 2021, could have allowed the entry of #aducanumab into Canada. A drug USFDA approved for Alzheimer's disease but which our regulator + the European Medicines Agency effectively rejected due to its poor effectiveness and significant safety risks.
January 19, 2026 at 3:05 PM
I also explain how this mechanism, if in place in 2021, could have allowed the entry of #aducanumab into Canada. A drug USFDA approved for Alzheimer's disease but which our regulator + the European Medicines Agency effectively rejected due to its poor effectiveness and significant safety risks.
Which is why I draw the comparison in @thestar.com to the "tainted blood scandal" of the 1980s when Canada relied on the US for blood products (and USFDA licensed for export to Canada) and thousands of Canadians suffered harm as a result.
January 19, 2026 at 3:05 PM
Which is why I draw the comparison in @thestar.com to the "tainted blood scandal" of the 1980s when Canada relied on the US for blood products (and USFDA licensed for export to Canada) and thousands of Canadians suffered harm as a result.
On its face, this mechanism - if implemented - would allow Health Canada to rely on the decisions of the US Food & Drug Administration.
That's the same agency that has been going to hell under President Trump and the anti-vaxxer RJK Jr. that he put in charge of the body that oversees USFDA.
That's the same agency that has been going to hell under President Trump and the anti-vaxxer RJK Jr. that he put in charge of the body that oversees USFDA.
January 19, 2026 at 3:05 PM
On its face, this mechanism - if implemented - would allow Health Canada to rely on the decisions of the US Food & Drug Administration.
That's the same agency that has been going to hell under President Trump and the anti-vaxxer RJK Jr. that he put in charge of the body that oversees USFDA.
That's the same agency that has been going to hell under President Trump and the anti-vaxxer RJK Jr. that he put in charge of the body that oversees USFDA.
It's especially troubling that the list of drugs and foreign regulators that are within the scope of this proposal have NOT been made public.
The GoC is consulting on the proposal till Feb. 28. But how can we comment intelligibly on the proposal when we have no idea of its scope!
The GoC is consulting on the proposal till Feb. 28. But how can we comment intelligibly on the proposal when we have no idea of its scope!
January 19, 2026 at 3:05 PM
It's especially troubling that the list of drugs and foreign regulators that are within the scope of this proposal have NOT been made public.
The GoC is consulting on the proposal till Feb. 28. But how can we comment intelligibly on the proposal when we have no idea of its scope!
The GoC is consulting on the proposal till Feb. 28. But how can we comment intelligibly on the proposal when we have no idea of its scope!
But other parts of the proposal, esp. the provision that would allow certain classes of drugs that have received approval in another country to enter the market through a 'General Deeming' (read: rubber stamping) process is completely novel.
January 19, 2026 at 3:05 PM
But other parts of the proposal, esp. the provision that would allow certain classes of drugs that have received approval in another country to enter the market through a 'General Deeming' (read: rubber stamping) process is completely novel.
Some of what's being proposed has happened for the past several years. Health Canada already collaborates with regulators in other countries to review products. We've written about that here, for eg.:
www.sciencedirect.com/science/arti...
www.sciencedirect.com/science/arti...
Competitive interdependence: A critical political economy of regulation during the COVID-19 pandemic
This article investigates Canada's health product regulatory authority, Health Canada (HC), and other major national regulators' responses to COVID-19…
www.sciencedirect.com
January 19, 2026 at 3:05 PM
Some of what's being proposed has happened for the past several years. Health Canada already collaborates with regulators in other countries to review products. We've written about that here, for eg.:
www.sciencedirect.com/science/arti...
www.sciencedirect.com/science/arti...
Just before the holidays, the GoC introduced a proposal that *could* create a pathway for new drugs (+ generics) to enter the Canadian market without the regulator vetting their evidence of safety & effectiveness.
That's a landmark change in Cdn law and creates risks to Canadians' health.
That's a landmark change in Cdn law and creates risks to Canadians' health.
January 19, 2026 at 3:05 PM
Just before the holidays, the GoC introduced a proposal that *could* create a pathway for new drugs (+ generics) to enter the Canadian market without the regulator vetting their evidence of safety & effectiveness.
That's a landmark change in Cdn law and creates risks to Canadians' health.
That's a landmark change in Cdn law and creates risks to Canadians' health.
December 19, 2025 at 9:29 PM
And so for a GoC that is hell bent on standing up for Canada in the face of threats from south of the border, I'm worried that our government will end up both relying on their (decimated) regulator & doing things in the name of efficiency that are downright DOGE-esque.
//end.
//end.
December 19, 2025 at 9:29 PM
And so for a GoC that is hell bent on standing up for Canada in the face of threats from south of the border, I'm worried that our government will end up both relying on their (decimated) regulator & doing things in the name of efficiency that are downright DOGE-esque.
//end.
//end.
I wonder what the scientific reviewers at Health Canada who have dedicated their lives to ensuring the safety of new drugs think about the proposed Order?
If implemented and frequently used, their jobs might soon be in jeopardy.
If implemented and frequently used, their jobs might soon be in jeopardy.
December 19, 2025 at 9:29 PM
I wonder what the scientific reviewers at Health Canada who have dedicated their lives to ensuring the safety of new drugs think about the proposed Order?
If implemented and frequently used, their jobs might soon be in jeopardy.
If implemented and frequently used, their jobs might soon be in jeopardy.
Why do I say that?
The proposed Order seems in keeping with the spirit of Division 5 of Bill C-15, which as @althiaraj.bsky.social wrote would give sweeping powers to exempt certain products from regulatory safeguards.
www.thestar.com/politics/pol...
The proposed Order seems in keeping with the spirit of Division 5 of Bill C-15, which as @althiaraj.bsky.social wrote would give sweeping powers to exempt certain products from regulatory safeguards.
www.thestar.com/politics/pol...
Althia Raj: Mark Carney is quietly giving sweeping new powers to his ministers
Sneaking a change of this magnitude into a 600-page bill that will not get parliamentary scrutiny raises a red flag, Althia Raj writes.
www.thestar.com
December 19, 2025 at 9:29 PM
Why do I say that?
The proposed Order seems in keeping with the spirit of Division 5 of Bill C-15, which as @althiaraj.bsky.social wrote would give sweeping powers to exempt certain products from regulatory safeguards.
www.thestar.com/politics/pol...
The proposed Order seems in keeping with the spirit of Division 5 of Bill C-15, which as @althiaraj.bsky.social wrote would give sweeping powers to exempt certain products from regulatory safeguards.
www.thestar.com/politics/pol...
But it seems this GoC is full steam ahead on the theory that this might drive industry to launch in Canada and save costs at the same time.
It's part of a larger trend with the Carney government.
It's part of a larger trend with the Carney government.
December 19, 2025 at 9:29 PM
But it seems this GoC is full steam ahead on the theory that this might drive industry to launch in Canada and save costs at the same time.
It's part of a larger trend with the Carney government.
It's part of a larger trend with the Carney government.
That should be reason enough not to go down this road.
But when you take into account the risk of industry capture and what's happening at the @usfda.bsky.social of late, the idea that we would rely upon another regulator looks even worse.
CC @reshmagar.bsky.social @jsross119.bsky.social
But when you take into account the risk of industry capture and what's happening at the @usfda.bsky.social of late, the idea that we would rely upon another regulator looks even worse.
CC @reshmagar.bsky.social @jsross119.bsky.social
December 19, 2025 at 9:29 PM
That should be reason enough not to go down this road.
But when you take into account the risk of industry capture and what's happening at the @usfda.bsky.social of late, the idea that we would rely upon another regulator looks even worse.
CC @reshmagar.bsky.social @jsross119.bsky.social
But when you take into account the risk of industry capture and what's happening at the @usfda.bsky.social of late, the idea that we would rely upon another regulator looks even worse.
CC @reshmagar.bsky.social @jsross119.bsky.social