As we have previously reported, the Minister of Health (Minister) approved the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order for Drugs and Vaccines) on September 16, 2020 and the Interim order respecting the importation and sale of medical devices for use in relation to COVID-19 (Interim Order for Medical Devices) on March 18, 2020.
Both interim orders are set to expire 1 year after they were issued, or sooner if withdrawn by the Minister. Any authorization for drugs, vaccines, and medical devices issued pursuant to the interim orders are also set to terminate when the respective interim order expires or is withdrawn.
Health Canada has now begun the consultation process to transition drugs, vaccines and medical devices that were authorized under the interim orders to a more permanent market authorization under the relevant regulatory regime.
Drugs and Vaccines
Health Canada has published a proposal titled “Consultation on amending the Food and Drug Regulations (FDR) to expedite access to COVID-19 drugs”. The proposed amendments to the FDR will allow COVID-19 products that were previously approved under the Interim Order for Drugs and Vaccines to apply for a notice of compliance (NOC) using a similar streamlined regulatory process. This includes amendments that will:
- provide the Minister with the authority to impose and/or amend terms and conditions on COVID-19 drugs at any time, upon authorization or while on the market;
- allow COVID-19 drugs to submit a New Drug Submission (NDS), but not a biosimilar product application or an abbreviated new drug submission, on a rolling basis;
- allow for the early importation (i.e., pre-positioning) of a COVID-19 drug before that drug receives market authorization in Canada, in specified circumstances;
- allow the Minister to impose terms and conditions on a drug establishment licence for a COVID-19 drug or activity at any time;
- require market authorization holders to meet post-marketing regulatory requirements; and
- continue to exclude COVID-19 drugs from brand-name assessments, including a look-alike/sound-alike assessment and labeling mock-ups, at the time of submitting an NDS.
The FDR amendments mean that COVID-19 drugs and vaccines will now be entitled to data protection, as well as rights under the Patented Medicines (Notice of Compliance) Regulations and the Certificate of Supplementary Protection regime.
The FDR amendments will not completely mirror the regulatory pathways that were permitted under the Interim Order for Drugs and Vaccines. Sponsors will be required to file an NDS with a complete data package for products previously authorized through the foreign decision pathway, or a supplemental NDS for drugs previously authorized under the expanded indication pathway.
Subsequent entry drugs (i.e., generics and biosimilars) addressing shortages under the Interim Order for Drugs and Vaccines will also not be reflected in the FDR amendments. Shortages will be addressed by other means. Subsequent entry sponsors will still be able to apply, but will need to respect the timelines provided for the existing data and patent protections.
Once the FDR amendments are in effect, all COVID-19 drugs applying for a new authorization will be required to apply for an NOC under the amended FDR pathway, rather than proceeding under the Interim Order for Drugs and Vaccines pathway.
Where authorizations granted under the interim order lapse and are not eligible for an NOC under the FDR amendments, Health Canada proposes using the following regulatory mechanisms to ensure continued access to the Canadian market:
- an application under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19;
- an application to be listed on the List of drugs for an urgent public health need; or
- an authorization or expanded indication through a product-specific interim order issued by the Minister.
Health Canada anticipates that the FDR amendments will be in effect by March 16, 2020, in order to give manufacturers 6 months to file and obtain their NOC prior to the expiry of the Interim Order for Drugs and Vaccines on September 16, 2021.
The FDR amendments are anticipated to remain in effect indefinitely, pending the status of the pandemic.
Consultation on the transition approach is open until December 21, 2020.
The Interim Order for Medical Devices provides a streamlined regulatory process to authorize the importation or sale of medical devices used to diagnose, treat, mitigate or prevent COVID-19. This interim order will expire on March 18, 2021 as will any device authorizations issued under the interim order. Health Canada is developing a transition plan to ensure these products can continue to be imported and sold into Canada.
The first phase will see a second interim order issued in March 2021 to maintain the current regulatory flexibility and continue the authorization for devices approved under the Interim Order for Medical Devices. The new interim order is expected to introduce the following changes.
- Importers and distributors of authorized devices would be given 6 months to apply for and obtain a medical device establishment licence.
- Manufacturers would be required to provide bilingual labelling under certain circumstances. Current authorized devices would have 6 months to comply with the new labelling requirements.
In the fall of 2021, regulatory amendments to the Medical Device Regulations (MDR) are expected take effect and remain in force for 2 years.
Under the MDR amendments, Class I devices (e.g., face masks and nasal swabs) authorized under the Interim Order for Medical Devices would be permitted to be imported and sold under a temporary licence for 18 months. After that time, manufacturers would need to comply with the standard MDR requirements for Class I devices.
For Class II, III, and IV medical devices, (e.g., test kits and ventilators), the MDR amendments will deem active authorizations under the Interim Order for Medical Devices to be valid medical device licences under the MDR for up to 2 years. Manufacturers of these devices will be able to ‘opt out’ if they do not want a deemed medical device licence.
Manufacturers would be issued a standard medical device licence only after they:
- receive a Medical Device Single Audit Program Quality Management System certificate;
- demonstrate that they have completed or made satisfactory progress on any terms and conditions placed on their interim order authorization; and
- for Class III and IV devices, include any additional clinical evidence, marketing history reports, or post-marketing data that builds on the information already submitted for the initial authorization.
Health Canada has reached out to manufacturers who have applied under the Interim Order for Medical Devices for their input on the proposed transition plan.