Drug approval

Drug approval

Unsafe by any name

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Resource Language: 
English
Owning Org: 
Canadian Women's Health Network (CWHN)
Media Type: 
Paper
Author: 
Carla Marcelis
Mira Shiva
Edition: 
Vol 7, No.4
Publisher: 
Women Healthsharing
Publication Date: 
1986
Publication Place: 
Toronto, ON

This article discusses how the marketing of controversial drugs in developing countries demonstrates the power and priorities of the pharmaceutical industry. Example highlighted: Estrogen-Progesterone combination drugs. 

Working for consumer rights, safe medicines and products

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Resource Language: 
English
Media Type: 
Online
Publisher: 
Pharmawatch Canada

PharmaWatch’s blog seeks to shed light on some of the most significant policy, research, legislative and program issues related to the safety and efficacy of prescription drugs, vaccines and medical devices in Canada. They believe that the Canadian public, patients, physicians, policy analysts, researchers, academics, authors, politicians and the media have a right to know how our drug approval and monitoring system works, how it compares to other international jurisdictions, the factors influencing decision making and whether Health Canada is protecting our health and safety.

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Keeping an eye on prescription drugs, keeping Canadians safe

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Resource Language: 
English
Media Type: 
Online
Author: 
Mary Wiktorowicz
Joel Lexchin
Kathy Moscou
Leslie Dan
Ann Silversides
Laura Eggertson
Publisher: 
Health Council of Canada
Publication Date: 
2010
Publication Place: 
Toronto, ON

Finds that testing for safety and effectiveness of prescrption drugs in Canada takes place almost exclusively before medications are approved and that there are “few regulatory obligations once a product reaches the market.”Assesses the Canadian post-market systems of drug surveillance -  “pharmacovigilance” - and finds that there is no national system to test drugs for safety after they reach the market.

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Contact their office to order a copy. Also available online
ISBN/ISSN: 
ISBN 978-1-897463-84-0 PDF
ISBN 978-1-897463-85-7 Print
Notes: 
Includes bibliographical references.

MedEffect Canada

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Resource Language: 
English
Translated Title: 
MedEffet Canada
Media Type: 
Online
Publisher: 
Health Canada

MedEffect, launched in 2009, is Health Canada’s initiative to make it easier for consumers, patients, and health professionals to report adverse reactions and side effects, obtain new safety information on drugs and other health products, and learn and better understand the importance of reporting side effects.

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Available online.

Regulatory requirements for advertising: the distinction between advertising and other activities

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Resource Language: 
English
Translated Title: 
Politique: direction générale des produits de santé et des aliments: distinction entre les activités publicitaires et les autres activités
Media Type: 
Online
Publisher: 
Health Canada
Publication Date: 
1996
Publication Place: 
Ottawa, ON

Describes the distinction between advertising to promote the sale of a drug and activities that are not primarily intended to promote the sale of a drug (e.g., education, scientific exchange). These are the regulations that prohibit Direct-to-Consumer Advertising (DTCA) of prescription drugs.

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Available online.

Access to therapeutic products: the regulatory process in Canada

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Resource Language: 
English
Translated Title: 
L'accès aux produits thérapeutiques: le processus de réglementation au Canada
Media Type: 
Online
Publisher: 
Health Canada
Publication Date: 
2006

Explains how drugs and other therapeutic products are regulated by the Health Products and Food Branch of Health Canada.

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Order Information: 
Contact their office to order a copy. Also available online.
ISBN/ISSN: 
ISBN: 0-662-49101-7

The push to prescribe (webinar)

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Resource Language: 
English
Owning Org: 
Canadian Women's Health Network (CWHN)
Media Type: 
Online
Publisher: 
Canadian Women's Health Network
Publication Date: 
Recorded November 4, 2009

Online discussion with The Push to Prescribe (Women’s Press, 2009) editor Anne Rochon Ford and contributors Colleen Fuller and Abby Lippman on how drugs are produced, regulated, marketed, and used in ways that affect many aspects of everyday life, and the extent of these effects, and their special meaning for women.

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Available online.

The push to prescribe: women & Canadian drug policy

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Resource Language: 
English
Media Type: 
Paper
Author: 
Anne Rochon Ford, Ed.
Diane Saibil, Ed.
Publisher: 
Women’s Press (Now owned by Canadian Scolar's Press)
Publication Date: 
July 2009
Publication Place: 
Toronto, ON

Delves into the world of prescription drugs in Canada, and considers the impact on the health of women. From the inadequate testing of many drugs on women in clinical trials, to the sometimes questionable portrayal of women in illegal prescription drug advertising, Canadian drug policy has not always paid attention to how women and men are affected differently. 297pp, Paperback

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Order Information: 
Contact the publishing company to order.
ISBN/ISSN: 
ISBN -13 978-0-88961-478-9
Notes: 
Includes bibliographical references and index.

Submission from WHP to Health Canada in response to Blueprint for Renewal: Transforming Canada's Approach to Regulating Health Products and Food

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Resource Language: 
English
Translated Title: 
Soumission d'APSF à Santé Canada en réponse au Plan de renouveau : transformer l'approche de la réglementation des produits de santé et des aliments au Canada
Owning Org: 
Centres of Excellence for Womens Health (CEWH)
Women and Health Protection (WHP)
Media Type: 
Online
Author: 
Women and Health Protection
Publisher: 
Women and Health Protection
Publication Date: 
2006
Publication Place: 
Toronto, Ontario

Critique of Health Canada's “Blueprint for Renewal: Transforming Canada 's Approach to Regulating Health Products and Food.” Discusses direct-to-consumer advertising and the harms to women.

 

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Transparency and the drug approval process at Health Canada: policy brief

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Resource Language: 
English
Owning Org: 
Centres of Excellence for Womens Health (CEWH)
Women and Health Protection (WHP)
Media Type: 
Paper
Online
Author: 
Women and Health Protection
Publisher: 
Women and Health Protection
Publication Date: 
2006
Publication Place: 
Toronto, ON

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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