Scientific Advice Application

Step 1: Review the Process and Templates

We recommend that you review the general information on the Scientific Advice program, including the Scientific Advice process, before submitting your application. You may also want to review the following guidance and templates for use during the process:

• Patient Drug Information Form
• Briefing Book for Scientific Advice Template
• Briefing Book for Health Canada and Canada's Drug Agency Parallel Scientific Advice Template
• Guidance on the Briefing Book for Scientific Advice
• Briefing Document Template for NICE — Canada's Drug Agency Parallel Scientific Advice (available on request)
• Briefing Book Guidance for Company for NICE — Canada's Drug Agency Parallel Scientific Advice (available on request)
• Clarification on the Briefing Book for Scientific Advice Template
• Addendum to the Briefing Book for Scientific Advice Template
• Clarification on the Record of Scientific Advice Template

In addition, our Frequently Asked Questions may help you with any questions or concerns you may have.

Step 2: Read the Details

An application to the Scientific Advice program constitutes the applicant's agreement with the program policies, guidelines, and processes, as described on the Scientific Advice website. As part of your application, you will be required to declare that your company is aware of and agrees to the following:

• Disclaimer for Scientific Advice
• Confidentiality Guidelines for Scientific Advice
• Fee Schedule for Scientific Advice
• Parallel Scientific Advice process (if applicable): agree to the disclosure and exchange of project information between participating organizations. Please refer to the confidentiality and information sharing.

You will also be asked to indicate the permissions, if any, that your company grants in order for CDA-AMC to share company information and information produced through the Scientific Advice program with patient representatives involved in the program.

Click here for more information on patient involvement in the Scientific Advice program.
 

Step 3: Submit Online Application Form

Complete and submit the online application form.

You will be required to provide specific information about your drug on the application form. You may want to review the application form ahead of time to ensure that you have collected all the information required.

Some notes about the online application form:

• You are encouraged to apply at least 4 weeks before the Briefing Book submission date. An application will also reserve your preferred meeting time period.
• In selecting a time period for your Scientific Advice meeting, consider the time period required before the meeting, for the Briefing Book submission. Customization of timelines can be arranged in advance.
• The date proposed for the Scientific Advice meeting that you indicate in the application does not guarantee that it is available for booking. Please contact [email protected] to discuss the availability of time periods for meetings.

Scientific Advice staff will contact you within 10 business days of receipt of your application to confirm the eligibility of your product, set a time period for the Scientific Advice meeting, discuss next steps, and answer any questions you may have.