Parallel Scientific Advice

We offer parallel Scientific Advice in addition to our standard Scientific Advice that is done by only us. Applicants may request one of the following:

• parallel Scientific Advice with us and Canada's regulatory body, Health Canada
• parallel Scientific Advice with us and the UK's National Institute for Health and Care Excellence (NICE)
• standard Scientific Advice (done by only us).

Our health technology assessment partner in Quebec, Institut national d'excellence en santé et en services sociaux (INESSS) will join the parallel process with us and Health Canada, initially in an observatory role.

Benefit of Parallel Scientific Advice

Parallel Scientific Advice offers companies a streamlined approach to obtaining advice from multiple stakeholders. Companies will learn about the similarities in the advice provided by participating organizations and have an opportunity to clarify areas of divergence in order to confirm a single approach that meets the needs of each agency.

Key Timelines for Scientific Advice Offerings

NICE = National Institute for Health and Care Excellence. Note: These are estimated timelines for guidance purposes. Actual timelines will be issued when the application is approved.

Submit Online Application

Please indicate on the Scientific Advice online application form if a request is being made for parallel Scientific Advice with us and Health Canada or us and NICE. For the latter, applicants are required to also apply directly with NICE Scientific Advice. By requesting parallel Scientific Advice, applicants are deemed to give permission to us to disclose or exchange information related to the project with the participating organization(s).

Read more about confidentiality and information sharing in our Scientific Advice Program.

Briefing Book for Parallel Scientific Advice

A single briefing book should be prepared and submitted to each participating organization. The same questions should be posed to each participating organization. You may include one (1) or two (2) questions each, directed specifically to one of the participating organizations.

Briefing Book Template for Health Canada -  Parallel Scientific Advice
Guidance on the Briefing Book for our Scientific Advice

Available upon request:
Briefing Book Template for NICE - Parallel Scientific Advice
Briefing Book Guidance for Company for NICE - Parallel Scientific Advice

Parallel Scientific Advice Meeting

Us and Health Canada

Similar to the Standard Scientific Advice process, the joint Scientific Advice meeting with us and Health Canada provides an opportunity for the company to clarify and discuss preliminary advice presented by each organization. The company is also invited to provide a short presentation on the clinical development plan at the start of the meeting. This meeting will be held in Ottawa, Ontario, Canada* and is three (3) hours in length. INESSS will be invited to participate in an observatory role. Experts engaged by us will also participate in this meeting.

Us and NICE

The joint Scientific Advice meeting with us and NICE occurs earlier in the process compared to our standard process and provides an opportunity for the company to participate in an exploratory discussion based on the issues identified by us and NICE. This meeting is up to four (4) hours in duration and may be held in Toronto, Ontario, Canada or London, England*, based on the availability of meeting rooms and the preference specified by the company. Experts and patients engaged by us and NICE participate in this meeting in person or remotely.

*Please note that until further notice all meetings are being held virtually using video conferencing technology due to COVID-19.

Final Advice Report

For the parallel Scientific Advice process with us and Health Canada, each organization will issue separate advice reports. For the parallel Scientific Advice process with us and NICE, the company will receive a combined report that includes a joint summary that highlights areas of alignment between the organizations, followed by separate detailed advice reports from each organization.

Fees for Parallel Scientific Advice

We will assess its fee based on the complexity and scope of the project following the submission of the Briefing Book. Please read more information on the fee for our Scientific Advice. At this time, no fee is requested by Health Canada. A separate fee will be determined by NICE.

Please contact [email protected] if you have any questions.

Information at a Glance

^aPlease note that until further notice all meetings are being held virtually using video conferencing technology due to COVID-19.