Release of revised guidance document: considerations for inclusion of women in clinical trials and analysis of data by sex


The online consultation is now closed. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period.

This Health Canada guidance document updates the 1997 Guidance Document on the Inclusion of Women in Clinical Trials and has been developed to address the following:

  • To clarify the scope of the original guidance, including the populations to which it applies;
  • To provide further guidance to sponsors on issues not addressed or minimally addressed in the 1997 guidance document. These include: inadvertent pregnancy in the course of a clinical trial and inclusion of pregnant and breastfeeding women in clinical studies/trials;
  • To support and encourage good therapeutic product development practices, including new approaches and methodologies, to identify and analyze potential sex differences across the product life cycle;
  • To provide guidance within the current regulatory environment.

How to Get Involved

This consultation is open for comment starting January 9, 2012 until April 16, 2012. Please select and read through the link below titled "Consultation Document". Once read please submit your comments using the "Form for Comments" below or using similar formatting via email, fax or by mail to:

Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Health Canada
Building 7, Tunney's Pasture
Ottawa, ON K1A 0K9
Address Locator: 0702B

Fax: (613) 952-5364

Interested parties are encouraged to provide comments and suggestions by April 16, 2012.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.

If you have any questions, contact us at

Page details

Date modified: