Documents and Reports Summer 2006 e-consultation report Stakeholder Consultation Workshop Summary Report - March 2007 Discussion document - March 2007 Presentation - March 2007 Related information Food and Drugs Act Food and Drug Regulations Regulatory Amendments and RIAS Good Clinical Practices Guidelines

Review of the Regulatory Framework for Clinical Trials

In 2001, Health Canada established a new clinical trial regulatory framework to strengthen its existing regulations, particularly in the areas of compliance and enforcement.

The 2001 amendments to Part C, Division 5 of the Food and Drug Regulations (Drugs for Clinical Trials Involving Human Subjects) had two objectives:

• to strengthen protections for human research participants, and
• to attract and sustain investment in research and development in Canada.

In the Regulatory Impact Analysis Statement (RIAS), which accompanied the 2001 amendments, Health Canada committed to assessing the impact of the regulations within three to five years. In response to this commitment, Health Canada:

1. launched a public e-consultation in June 2006 in the form of an online questionnaire, with two primary objectives: to receive input from the public and stakeholder community on the impact and effectiveness of the 2001 clinical trial regulatory framework, and to seek advice to improve the clinical trial framework design or implementation for the future.
   
   The report Clinical Trials Regulatory Framework Review - Results of 2006 E-consultation summarizing the results of the summer 2006 e-consultation is now available.
   
   
2. held a stakeholder workshop on March 26, 2007 in Ottawa to seek specific input from stakeholders on ways to improve Canada's regulatory framework for clinical trials, building on the results of the summer 2006 e-consultation. The Discussion Summary Report, Discussion Document, and Presentation are now available.

Next steps

Results from the electronic consultation and the stakeholder workshop will help inform the development of short, medium and long-term measures to strengthen the regulatory framework for clinical trials. Additional consultations will be undertaken by the Branch as necessary as we move forward on this initiative, including through the Canada Gazette process if regulatory amendments are being considered. We invite you to visit this web site regularly to obtain more information as we progress on this initiative.

Engaging Canadians

We invite you to continue providing your views and suggestions on ways to improve the clinical trials regulatory framework for the future by using the following email address: clinical_trials_regulatory_review@hc-sc.gc.ca.

Need more information?

If you have any questions, contact us at clinical_trials_regulatory_review@hc-sc.gc.ca.