As previously reported here, on September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order), which introduced a new pathway to expedite the authorization for importing, selling and advertising of COVID-19 drugs. As of April 15, 2021, Health Canada had granted seven (including five vaccine) authorizations under the ISAD Interim Order. As the ISAD Interim Order expires on September 16, 2021, the Food and Drug Regulations (FDR) were amended on March 18, 2021 - Regulations Amending the Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19) - to allow, among other things, continued sale of COVID-19 drugs authorized under the ISAD Interim Order. See accompanying Notice and Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19.
Generally, amendments to the FDR related to the authorization pathways and associated submission flexibilities, including the modified safety and efficacy information requirements, rolling submissions, and terms and conditions, came into force on March 18, 2021. Most amendments relating to drug establishment licencing (DEL), good manufacturing practices (GMP), pre-positioning and other provisions relating to authorization pathways will come into force upon expiry of the ISAD Interim Order, on September 16, 2021.
As explained in the Regulatory Impact Analysis Statement:
“These amendments to the FDR will allow for continued and timely access to safe and effective COVID-19 drugs for Canadians by normalizing the review, authorization and oversight of these drugs under the FDR by
Intellectual property consequences –Sponsors may now benefit from intellectual property protections available in connection with submissions resulting in a notice of compliance (NOC), namely data protection, protection under the Patented Medicines (Notice of Compliance) Regulations, and protection under the Certificate of Supplementary Protection regime.
Deadlines - To maintain the ability to sell, import or conduct other licensable activities related to a COVID-19 drug, manufacturers holding an authorization are required to submit a New Drug Submission (NDS) or Supplement to a New Drug Submission (SNDS) within
An authorization under the ISAD Interim Order will be revoked if
A manufacturer will be permitted to continue selling, within the scope of their authorization, the COVID-19 drug once the ISAD Interim Order ceases to have effect if
If the holder of an Interim Order authorization is not able to file an NDS or an SNDS, as applicable, within the given timeline, the Interim Order authorization is revoked, and the manufacturer will have to wait until receiving an NOC to continue sale.