Canada's streamlined approval process raises protests

Wed, 09 Apr 2008 06:59:55 -0400

Canadian officials are batting down critics who say that the country's new, streamlined drug approval process will let unsafe therapies onto the market. The dispute centers on Canada's new standard for drug approval: The benefits offered by a new drug have to outweigh the harm it does. And critics see the shift as a significant retreat from earlier safety standards. The changes come as Health Canada adopts a "progressive licensing" approach, which calls for ongoing trials both before and after approvals to judge the safety of new therapies.

"I think that's a pretty dangerous thing to be doing," Joel Lexchin, a health policy professor at York University and drug safety expert tells the Globe and Mail. "This is part of a general trend in a lot of countries, at least with respect to the drug-approval system, [which] is deregulation, turning over more responsibility to the drug companies."

- read the article in the Globe and Mail

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Canadian regulators forging new biosimilar pathway

Tue, 25 Mar 2008 07:59:55 -0400

While U.S. lawmakers jawbone about a regulatory pathway for biosimilars, or biogenerics, Canada has moved to do it. Health Canada has posted draft guidelines for its regulatory approach to biosimilars. Manufacturers would have to show their products were similar to an existing biologic with interchangeability and substitutability decided on a case-by-case basis. New guidances are being drafted for various product classes.

In the U.S., meanwhile, there have been growing signs that any new legislation on biosimilars could be delayed past the current election year. But in Europe, regulators are busily approving a new slate of follow-on therapeutics.

- check out the report from FDA News
- read the article on the EMEA's approvals in Motley Fool

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