Amending the Food and Drug Regulations to provide expedited access to COVID-19 drugs: Closed consultation 

From: Health Canada

The Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 introduced new regulatory pathways to expedite the authorization of COVID-19 drugs to meet a public health emergency without compromising patient safety. The interim order (IO) expires on September 16, 2021. To ensure uninterrupted access to these drugs, Health Canada proposed to amend the Food and Drug Regulations.

Who was the focus of this consultation

We engaged with:

• Canada.ca
• Departments and agencies
• Health Canada
• Programs and policy development – Health Canada

Key questions for discussion

Industry plays an important role in facilitating early access to these drugs. Through this consultation, Health Canada wanted to make sure key stakeholders:

• are aware of the transition approach we want to take to ensure COVID-19 drugs can continue to be authorized and marketed once the IO expires
• identify any concerns they have about these proposed measures

Ideas and input were sought on:

• comments or concerns with the implementation of these measures
• challenges as it relates to stakeholder ability to satisfy division 2 good manufacturing practice (GMP) requirements, either currently or in the early days of the pandemic
• useful measures to help overcome these challenges
• challenges anticipated in satisfying GMP requirements as the pandemic progresses
• comments or concerns about the proposed approach to fees for COVID-19 drugs

The input gathered through this process will help Health Canada’s work on amending the Food and Drug Regulations to ensure that Canadians continue to have access to COVID-19 drugs.

What we heard

Final report

• What was heard: Consultation on interim order transition for COVID-19 drugs

Contact us

Contact us by email: hc.hpfb-covid19-dgpsa.sc@canada.ca

Related links

• Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
• Explanatory note
• Information and application requirements for drugs authorized under the interim order: Guidance document
• Subsection 30.1(1) of the Food and Drugs Act