Search Resources (English): Drug approval, Women and Health Protection (WHP)

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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
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.

 (See Details)
Published: 2006
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
Women and adverse drug reactions: reporting in the Canadian context  
http://www.whp-apsf.ca/pdf/fullerReport.pdf
Provides an overview of how Canada's program for reporting Adverse Drug Reactions (ADRs) supports-or doesn't support-an effective women's health strategy related to prescription drug use. (See Details)
Published: 2002, 2003
Who benefits: international harmonisation of the regulation of new pharmaceutical drugs  
http://www.whp-apsf.ca/en/documents/who_benefits.html
Explains how the push to streamline the drug approval process in the world's three largest pharmaceutical markets is neglecting the special needs of women. (See Details)
Published: 2002
International harmonisation of pharmaceuticals: key issues of concern for public health  
http://www.whp-apsf.ca/en/documents/harmon.html
Focuses on the activities and implications of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Identifies specific areas of concern for public health and the public interest in the realisation of health. (See Details)
Published: 2001
Evra and the environment  
http://www.whp-apsf.ca/en/documents/evra.html
Explains, by using the Evra patch as an example, how the drug approval process does not take drug disposal into account. Lists ways to prevent unused or expired medications from entering the ecosystem. (See Details)
Published: 2004
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
Transparency and the drug approval process at Health Canada  
http://www.whp-apsf.ca/en/documents/transparency.html
Argues that the federal government is protecting drug companies instead of the public by keeping information about the drug approval process secret. Examines the impact of this on women's health. (See Details)
Published: 2005