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

Current status: Open

Opened on November 30^th, 2020, and closed on December 21^st, 2020.

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 is proposing to amend the Food and Drug Regulations.

Join in: how to participate

Review the proposal

Consultation on amending the Food and Drug Regulations to expedite access to COVID-19 drugs

Send us an email

hc.hpfb-covid19-dgpsa.sc@canada.ca

Who is the focus of this consultation

The Government of Canada will engage with:

importers
distributors
manufacturers
health system partners
other stakeholders

Key questions for discussion

Industry plays an important role in facilitating early access to these drugs. Through this consultation, Health Canada wants 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
will identify any concerns they have about these proposed measures

Your ideas and input are sought:

Are there any comments or concerns with the implementation of these measures?
Have you experienced challenges as it relates to your ability to satisfy division 2 good manufacturing practice (GMP) requirements, either currently or in the early days of the pandemic? If yes:
- what measures would be useful to help you overcome these challenges?
- do you anticipate challenges in satisfying GMP requirements as the pandemic progresses?
Are there any 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.

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