From the Globe and Mail:
The pharmaceutical industry, health experts and patient groups across Canada are strongly divided over whether the federal government's proposed new system for approving and monitoring drugs will result in harm or benefit to Canadians.
Under the proposed new "progressive licensing" system, Health Canada "will shift the focus from pre-market assessment to continuous assessment" of drugs, according to an article written by departmental officials and published last June in the Canadian Medical Association Journal.
The new system will "support timely access to drugs and provide a mechanism for the continuous monitoring and reassessment of a drug's safety" throughout its life cycle, states the article.
Some advocacy groups say the move is a much-needed development that will improve access to breakthrough, live-saving drugs or treatments for rare diseases. ...more
Showing posts with label drug approvals. Show all posts
Showing posts with label drug approvals. Show all posts
Sunday, April 13, 2008
Wednesday, April 09, 2008
Experts sound alarm on drug-approval plan
From the Globe and Mail:
The federal government moved yesterday to meet intense pressure to get new drugs on the market faster while maintaining rigorous safety requirements, but health experts warned that Canadians could be exposed to medicines that are approved too quickly to ensure safety.
The government introduced sweeping changes to the way drugs are approved and monitored such that they will require safety checks before and after they reach the market. The changes are among consumer-product safety measures unveiled in Ottawa.
Health Minister Tony Clement said the rules won't water down safety requirements for new drugs, and the continued monitoring will improve the government's ability to spot problems.
"I can assure you we are not going to change our standards or change our stringent review," Mr. Clement said in an interview. "Our work is going to remain as intense." ...more
The federal government moved yesterday to meet intense pressure to get new drugs on the market faster while maintaining rigorous safety requirements, but health experts warned that Canadians could be exposed to medicines that are approved too quickly to ensure safety.
The government introduced sweeping changes to the way drugs are approved and monitored such that they will require safety checks before and after they reach the market. The changes are among consumer-product safety measures unveiled in Ottawa.
Health Minister Tony Clement said the rules won't water down safety requirements for new drugs, and the continued monitoring will improve the government's ability to spot problems.
"I can assure you we are not going to change our standards or change our stringent review," Mr. Clement said in an interview. "Our work is going to remain as intense." ...more
Mixed reactions to Ottawa's new drug safety proposals
From CBC News:
Federal government proposals to change the way drug safety is monitored in Canada have drawn a mixed response.
On Tuesday, consumer safety legislation was tabled in the House of Commons that includes requirements for health-care institutions to report adverse drug reactions, demands continuing surveillance of drugs after they've been approved and raises fines for unsafe drugs from $5,000 to a minimum of $5 million.
While some experts say the new rules will improve the government's ability to protect the public, critics say it has the potential to expose Canadians to more risk.
Dr. Joel Lexchin, a York University professor in Toronto, says he's concerned that the bill would give the federal health minister the ability to fast-track drug approvals. ...more
Federal government proposals to change the way drug safety is monitored in Canada have drawn a mixed response.
On Tuesday, consumer safety legislation was tabled in the House of Commons that includes requirements for health-care institutions to report adverse drug reactions, demands continuing surveillance of drugs after they've been approved and raises fines for unsafe drugs from $5,000 to a minimum of $5 million.
While some experts say the new rules will improve the government's ability to protect the public, critics say it has the potential to expose Canadians to more risk.
Dr. Joel Lexchin, a York University professor in Toronto, says he's concerned that the bill would give the federal health minister the ability to fast-track drug approvals. ...more
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