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

See the regulations notice  about the new Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations . These new Regulations, published in the Canada Gazette II on March 2, 2022, came into effect on February 27, 2022, following the repeal of the Interim Order No. 2.

Health Canada consulted with stakeholders about our transition approach to ensure that COVID-19 drugs can continue to be authorized. The consultation has ended and this report is a summary of the responses we received.

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About the interim order

For a drug to receive market authorization for the treatment of a specific indication, manufacturers are required to submit a drug submission under Part C, Division 8 of the Food and Drug Regulations. Health Canada then reviews the submission, which must contain enough evidence to show how their drug meets the safety, efficacy and quality requirements of the Regulations. Health Canada grants an authorization in the form of a notice of compliance (NOC) if it is determined that the benefits of the drug outweigh its potential risks.

To introduce new regulatory pathways to expedite the authorization of COVID-19 drugs, including vaccines, the Minister of Health created the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (ISAD IO). These pathways were created to meet a public health emergency without compromising patient safety.

To facilitate timely access, the interim order (ISAD IO) also introduced:

This IO expires on September 16, 2021, one year after it was introduced. Drugs approved through the IO will no longer be legally permitted to be sold in Canada, unless transition measures are implemented.

About the transition approach

To ensure uninterrupted access to these drugs, Health Canada published a proposal to amend the Food and Drug Regulations and the Fees for Drugs and Medical Devices Order on November 30, 2020. Once in place, the transition provisions will allow an NOC to be issued to manufacturers of COVID-19 drugs authorized under the IO. There will be no disruptions to market access once the IO expires in the fall of 2021.

The amendments will incorporate features from the IO’s regulatory pathways so that Health Canada can continue to provide Canadians with quick access to safe and effective COVID-19 drugs, and ensure the appropriate fees are charged. Once amended, new drug submissions can be filed under the Regulations.

Specifically, the amendments will:

About the consultation

Stakeholders were invited to submit comments on this proposal by December 21, 2020. They could submit in writing by accessing the online consultation or take part in an interactive stakeholder webinar session on December 11, 2020. Health Canada provided stakeholders with a set of questions ahead of time to facilitate the development of comments.

Forty-eight individuals participated in the webinar, including representatives from the pharmaceutical industry, professional associations and provincial health authorities. Health Canada also received 10 sets of written comments from pharmaceutical industry associations, companies and one professional association.

What stakeholders said

Overall comments

There was consensus on the transition proposal as a whole and strong support for the initiative to provide an orderly transition of drugs authorized under the IO.

Industry stakeholders also strongly encouraged Health Canada to consider keeping key aspects of the IO and transition provisions. They felt it is important to have a flexible regulatory framework for drugs to address future pandemics. They also stressed the need for:

Transition process and submission filing/processing procedures

Most of the comments and requests for clarification concerned the following items:

Health Canada will address these process-based questions in the guidance documents, which will be published as part of the regulatory package.

Stakeholders also stressed the importance of aligning Canadian requirements with those of our international regulatory partners. Harmonization will ensure Canada is not at a disadvantage when it comes to providing urgently needed drugs.

Next steps

Health Canada is grateful for all of the feedback provided on the transition process proposal, especially considering the short timelines. All comments have been considered and will help inform the guidance document that will accompany the regulations.

The regulations are intended for publication in the Canada Gazette, Part II in early 2021.

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