Consultation on proposed Phase II of the Summary Basis of Decision Project

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.

The Health Products and Food Branch (HPFB) of Health Canada is seeking your input on proposals for the next phase of the Summary Basis of Decision (SBD) project.

SBD documents describe the rationale for Health Canada's decision to authorize the sale of certain drugs and medical devices. The HPFB of Health Canada launched the SBD Project in 2005 to enhance the transparency of the pharmaceutical, biologic and medical device regulatory review processes. SBD is a joint initiative of the Biologics and Genetic Therapies Directorate and the Therapeutic Products Directorate.

HPFB is now embarking on a proposed Phase II of the SBD Project and wishes to seek the feedback of stakeholders. Changes proposed in Phase II of the SBD Project include a streamlining and reformatting of existing SBD information, as well as the inclusion of a new table listing post-authorization activities. In order to demonstrate these changes, three modified SBD documents (for a drug, a biologic and a medical device) have been posted for your review, along with consultation questions.

Please note that prior knowledge of the SBD Project is not a prerequisite to participation. If you would like more information on the SBD Project, please refer to the SBD section of the Health Canada website.

How to get Involved

This consultation is open for comment starting October 19, 2011 until December 19, 2011. Please review the pilot SBD documents and submit your responses to the consultation questions via email, fax or mail to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2^nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

Telephone: (613) 948-4623
Facsimile: (613) 941-1812
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca

Consultation Questions: To obtain a copy of the document that was consulted upon, please contact Policy_Bureau_Enquiries@hc-sc.gc.ca.

Pilot demonstration documents

• Drug
• Biologic
  • Post-authorization activity table (PAA)
• Medical Device
  • Post-licensing activity table (PLA)

Interested parties are encouraged to provide responses to the consultation questions by December 19, 2011. If you have any questions regarding the consultation, please send them to Policy_Bureau_Enquiries@hc-sc.gc.ca.