Parallel Scientific Advice Process

Benefit of the Parallel Scientific Advice Process

Parallel Scientific Advice offers applicants a streamlined approach to obtaining advice from 2 agencies. Applicants 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.

Canada’s Drug Agency (CDA-AMC) offers Parallel Scientific Advice with the National Institute for Health and Care Excellence (NICE). Parallel Scientific Advice may be requested with Health Canada and is offered on a case-by-case basis.

“Joint scientific advice from NICE and CADTH helped ensure we designed our phase III trial in the right way, setting ourselves up for success in the UK and Canada.”

-    Market Access Manager, Canadian Affiliate of Global Pharma Company 

Key Timelines for Scientific Advice Offerings

NICE = National Institute for Health and Care Excellence.
^aParallel Scientific Advice with Health Canada follows the standard process and is available on a case-by case basis.
^bCustomization in the process and/or timelines can be considered.
Note: These are estimated timelines for guidance purposes. Actual timelines will be issued when the application is confirmed.
 

Submit Online Application

Please indicate on the Scientific Advice online application form  if a request is being made for Parallel Scientific Advice. For requests with NICE, applicants are required to also apply directly with NICE Advice. For requests with Health Canada, applicants are required to contact us in advance to determine feasibility.

By requesting Parallel Scientific Advice, applicants are deemed to give permission to CDA-AMC to disclose or exchange information related to the project with the participating organization(s).

Read more about confidentiality and information sharing in the 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

Scientific Advice Meeting

Canada's Drug Agency

The Standard Scientific Advice process, includes a Scientific Advice meeting with CDA-AMC and experts engaged by CDA-AMC. The company is invited to provide a short presentation on the clinical development plan at the start of the meeting. This meeting will be virtual (unless otherwise requested) and is three (3) hours in length.

The same process is used for Parallel Scientific Advice with CDA-AMC and Health Canada. Additionally, INESSS will be invited to participate in an observatory role.
 

Canada’s Drug Agency and NICE

The joint Scientific Advice meeting with CDA-AMC and NICE occurs earlier in the process compared to the Standard Scientific Advice process and provides an opportunity for the sponsor to participate in an exploratory discussion based on the issues identified by CDA-AMC and NICE. This meeting will be virtual and is up to 4 hours in duration. Experts and patients engaged by CDA-AMC and NICE participate in this meeting.

Final Advice Report

For the Parallel Scientific Advice process with CDA-AMC and Health Canada, each organization will issue separate advice reports. For the Parallel Scientific Advice process with CDA-AMC 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

CDA-AMC 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 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

Note: for Parallel Scientific Advice with Health Canada, the standard process is followed with the following exceptions: a single Briefing Book with the same questions directed to both organizations and up to 2 questions each directed to either organization; separate advice reports from each agency.