Last Updated : September 30, 2020
CADTH offers parallel Scientific Advice in addition to its standard CADTH-only Scientific Advice. Applicants may request one of the following:
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.
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 milestones||Standard CADTH only||Parallel with CADTH
and Health Canada
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.
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.
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 - CADTH Parallel Scientific Advice
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
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 (3) hours in length. INESSS will be invited to participate in an observatory role. Experts engaged by CADTH will also participate in this meeting.
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.
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.
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 email@example.com if you have any questions.
|Standard CADTH Scientific Advice (CADTH only)||Parallel Scientific Advice with CADTH and Health Canada||Parallel Scientific Advice with CADTH and NICE|
|CADTH online application form||CADTH online application form||CADTH online application form and application with NICE|
|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 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
|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
|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.