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.
On this page
- About the interim order
- About the transition approach
- About the consultation
- What stakeholders said
- Next steps
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:
- certain flexible measures for drug establishment licensing and good manufacturing practices (GMP) and
- a mechanism to allow pre-positioning of promising COVID-19 drugs before their authorization in Canada
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:
- allow continued and timely access to safe and effective COVID-19 drugs for Canadians by supporting continued flexibilities in the review, authorization and oversight of COVID-19 drugs
- enable the sale and advertising of COVID-19 drugs that were authorized under the IO to continue after the IO expires
- enable new COVID-19 drugs that hadn’t been authorized under the IO to seek authorization under the Regulations with similar flexibilities as those provided under the IO
- permit continuity of the post-market regulatory obligations placed on authorization holders, manufacturers and importers after the IO expires
- continue to allow the early importation (pre-positioning) of a promising COVID-19 drug for which a federal government contract for its procurement is in place, before that drug receives market authorization in Canada
- continue an agile approach for drug establishment licences (DELs) that authorizes regulated activities for COVID-19 drugs
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
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:
- a guidance document that will accompany the regulatory amendments, to be issued as soon as possible for comment and
- clarification on interpretations of the amendments in the guidance document
Transition process and submission filing/processing procedures
Most of the comments and requests for clarification concerned the following items:
- submission filing procedures
- applicable fees
- timelines for bringing a drug authorized under the ISAD IO through a submission under the Regulations
- the type and amount of information that would need to filed
- the extent of the Health Canada review of a product that had already received an authorization under the IO
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.
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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