Consultations launched on fast-track reviews for rare disease medications
Health Canada has launched consultations on draft guidance it has published identifying new criteria aimed at accelerating reviews of new drugs for patients suffering from rare or debilitating diseases.
"Canadians with rare diseases already face enough challenges, without having to worry about lengthy approvals and regulatory delays,” said Ginette Petitpas Taylor, Minister of Health in a May 13 statement. “By streamlining the review process, we will ensure they get can access to treatments they need as quickly as possible."
The draft guidance proposes to take into consideration the needs of patients and the health care system when deciding whether to fast-track a particular review, says Health Canada.
For example, the current priority review process allows only the first drug in a certain class or the first drug for a specific condition to be prioritized. The proposed guidance “aims to broaden the eligibility criteria for accelerated review, allowing more drugs to go through a fast-track review to get them to the patients who need them sooner, while still ensuring safety,” says Health Canada.
To learn more, consult the guidance here. The consultation is accepting feedback on the draft guidance until July 21.