Early scientific advice to manufacturers

This project will result in Health Canada and Health Technology Assessment (HTA) organizations working together. This will allow them to give scientific advice to manufacturers at the same time early in the drug development process. Patient involvement will be an important part of the process.

At this time, Health Canada and Canadian HTA organizations work independently to give scientific advice to drug manufacturers. Once a drug is developed, Health Canada must give an authorization before the drug can be marketed.

After market authorization the HTA organizations give drug funding recommendations to:

• federal drug plans
• provincial drug plans
• territorial drug plans
• cancer organizations

Examples of Canadian organizations that do HTAs are the:

• Canadian Agency for Drugs and Technologies in Health (CADTH)
• Institut national d'excellence en santé et en services sociaux (INESSS)

By giving early scientific advice at the same time, Health Canada and the HTA organizations will help manufacturers to produce better quality information from clinical trials. Information from clinical trials is used by both Health Canada and the HTA organizations to make drug approval decisions and funding recommendations. Better information will allow for better decisions. This also has the potential to get the drugs that are needed by the health care system to patients sooner.

Tasks for this project include:

• developing a document that analyses the issue
• testing the new process (Mid 2018)
• developing a guidance document for consultation in 2019

We expect that all parts of this project will be fully in place by spring 2020.