Search Resources (English): Drug approval

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International harmonisation of new drugs regulation: not in women's best interest  
http://www.cwhn.ca/sites/default/files/PDF/CEWH/RB/bulletin-vol3no2EN.pdf

Examines the question of harmonisation of pharmaceutical regulation and its implications for women and public health. Urges that safety standards be paramount and the particular needs of women and other groups are not lost.

 (See Details)
Published: 2003
Public opinion survey on key issues pertaining to post-market surveillance of marketed health products in Canada: final report  
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_res-rec/2004-decima_2003_final_rep-rapp/index-eng.php

Presents the results of a survey where Canadians were asked to give their views and opinions on the effectiveness of Health Canada's methods to communicate health product safety information.

 (See Details)
Published: 2003
Transparency in drug regulation: mirage or oasis?  
http://www.policyalternatives.ca/documents/National_Office_Pubs/transparency.pdf

Criticizes the Therapeutic Products Directorate (TPD), the arm of Health Canada in charge of testing and approving new drugs, particularly its dependence on funding from the pharmaceutical industry. Finds that these close ties with the pharmaceutical firms has led to the concealment of scientific or technical information about the safety and efficacy of new drugs.

 (See Details)
Published: 2004
Drug regulatory failure in Canada: the case of Diane-35  
http://www.whp-apsf.ca/en/documents/diane35.html

Criticizes federal prescription drug regulation using Diane-35 (cyproterone acetate and ethinyl estradiol) as an example.

 (See Details)
Published: 2004
Transparency and the drug approval process at Health Canada: policy brief  
http://www.whp-apsf.ca/en/documents/trans_policy.html

Argues that the lack of transparency in the drug approval process can lead to inappropriate, unnecessary and sometimes dangerous drug use, and it impedes the development of knowledge and appropriate decision-making.

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Published: 2006
Post-approval surveillace of drug products available to treat infertility
Outlines the work accomplished by the Bureau of Drug Surveillance in response to the concerns of the Royal Commission on New Reproductive Technologies regarding the health effects of drugs to treat infertility.
Published: 1996
How safe are our medicines? Monitoring the risks of drugs after they are approved for marketing  
http://www.whp-apsf.ca/en/documents/how_safe.html
Discusses the drug approval process in Canada, post-approval drug surveillance, adverse drug reactions, and notification of those at risk of harm. Recommends measures to ensure drug safety for Canadian women and their families. (See Details)
Published: 2000
Significant bone loss associated with Depo-Provera use is sadly no surprise; we call for action to make sure this doesn't happen  
http://www.cwhn.ca/pr/11-19-04.html
Discusses the debate surrounding Depo-Provera's approval for contraception use in 1997 when women's groups had already highlighted it's impact on bone mineral density. (See Details)
Published: 2004
Report of the Royal Commission on the Future of Health Care in Canada: response from the Women and Health Protection (WHP) Worki  
http://www.whp-apsf.ca/en/documents/whp_response.html
Addresses six themes found primarily in the "Prescription Drugs" and the "Information, Evidence and Ideas" chapters of The Report of the Royal Commission on the Future of Health Care in Canada. (See Details)
Published: 2003
Same tune, different lyrics: the Vioxx story  
http://www.cwhn.ca/node/39500
Illustrates the flaws in the Canadian drug approval and drug regulatory processes, using the current Vioxx scandal as example. (See Details)
Published: 2005