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Parallel Scientific Advice Meeting

CADTH offers parallel Scientific Advice in addition to its standard CADTH-only Scientific Advice. Applicants may request one of the following:

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

Our health technology assessment partner in Quebec, Institut national d'excellence en santé et en services sociaux (INESSS) will join the parallel process with CADTH 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 CADTH Scientific Advice Offerings

Key milestones Standard
CADTH only
Parallel with CADTH and Health Canada Parallel with CADTH and NICE
Submit online application Week -4 Week -4 Week -4
Submit briefing book Week 0 Week 0 Week 0
Joint Scientific Advice meeting Week +14 Week +14 Week +10
Receive advice report Week +18 Week +18 Week +20

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 CADTH Scientific Advice online application form if a request is being made for parallel Scientific Advice with CADTH and Health Canada or CADTH 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 CADTH to disclose or exchange information related to the project with the participating organization(s).

Read more about confidentiality and information sharing in the CADTH 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.

Link to Briefing Book Template for Health Canada — CADTH Parallel Scientific Advice
Link to Guidance on the Briefing Book for CADTH Scientific Advice

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

Parallel Scientific Advice Meeting

CADTH and Health Canada

Similar to the Standard CADTH Scientific Advice process, the joint Scientific Advice meeting with CADTH 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 and one-half (3 ½) hours in length. INESSS will be invited to participate in an observatory role. Experts engaged by CADTH will also participate in this meeting.

CADTH and NICE

The joint Scientific Advice meeting with CADTH and NICE occurs earlier in the process compared to the standard CADTH process and provides an opportunity for the company to participate in an exploratory discussion based on the issues identified by CADTH 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 CADTH 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 CADTH and Health Canada, each organization will issue separate advice reports. For the parallel Scientific Advice process with CADTH 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

CADTH 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 CADTH Scientific Advice. At this time, no fee is requested by Health Canada. A separate fee will be determined by NICE.

Please contact scientificadvice@cadth.ca if you have any questions.

Information at a Glance

Standard CADTH Scientific Advice (CADTH only) Parallel Scientific Advice with CADTH and Health Canada Parallel Scientific Advice with CADTH and NICE
Application
CADTH online application form CADTH online application form CADTH online application form and application with NICE
Briefing book
Single briefing book Single briefing book with the same questions directed to both participating organizations
Up to 2 questions each, directed to CADTH or Health Canada Up to 2 questions each, directed to CADTH or NICE
Scientific Advice meeting (duration, format, locationa)
3 hours 3.5 hours Up to 4 hours
Discussion of preliminary advice Discussion of preliminary advice Exploratory discussion
Ottawa, Ontario or
Toronto, Ontario, Canada
Ottawa, Ontario, Canada Toronto, Ontario Canada or
London, England
Final advice report
CADTH Record of Scientific Advice Separate advice reports issued by CADTH and Health Canada Combined advice report,
includes joint summary and separate advice reports from CADTH and NICE
Fee
CADTH fee only CADTH fee only CADTH fee and NICE fee

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