Transparency is a fundamental good regulatory practice and a clear expectation of the Canadian public. Health Canada is committed to enhancing the transparency of the regulatory review process for drugs and medical devices. The Summary Basis of Decision initiative was developed in 2004 in demonstration of this commitment to transparency. As part of the Summary Basis of Decision initiative, Health Canada publishes Notice of Decision and Summary Basis of Decision documents.
Health Canada is undertaking an evaluation of phase I of the Summary Basis of Decision initiative. As part of this evaluation, we are asking stakeholders to complete this workbook and submit it to OBT_enquiries@hc-sc.gc.ca by May 15, 2009.
The consultation workbook can be completed and submitted on-line starting April 7, 2009 until May 15, 2009 inclusive.
Interested stakeholders are encouraged to complete and submit the consultation workbook by May 15, 2009.
If you have any questions, contact us at:
Office of Business Transformation
Phone: 613-941-1248
Fax: 613-957-1483
Email: obt_enquiries@hc-sc.gc.ca
The results of the evaluation of phase I of the Summary Basis of Decision initiative will be published on the Health Canada Web site in summer/fall 2009.