On April 16, 2019, Health Canada released a notice inviting drug submissions containing high quality real world evidence along with a document providing principles for the collection and evaluation of real world evidence.
Submissions containing real world evidence are encouraged in the following circumstances: to “expand evidence-based indications for populations often excluded from clinical trials”; “for drugs/diseases where clinical trials are unfeasible”; or “where clinical trials are unethical”. Sponsors must clearly identify that a submission contains real world evidence. When real world evidence is used as pivotal evidence, a sponsor must also (i) provide a rationale for its use; (ii) provide a detailed explanation of its collection/analysis; (iii) demonstrate how biases in data collection were mitigated; and (iv) contact Health Canada to determine whether a pre-submission meeting would be beneficial.
A further joint document regarding the use of real world evidence is in development by Health Canada, CADTH and INESSS with an anticipated release date of later this year.
Related Publications & Articles
-
Federal Court of Appeal dismisses appeal of SPRAVATO “innovative drug” decision
On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data...Read More -
CIPO will not issue patents on July 9 or July 16
The Canadian Intellectual Property Office (CIPO) will be launching a new online portal for patent services, MyCIPO Patents, on July 15, 2024.Read More -
2024 mid-year highlights in Canadian life sciences IP and regulatory law
In the first half of 2024, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories ...Read More