The Food and Drug Regulations (FDR) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance (NOC) under the FDR. Certain provisions of the amendments came into force on March 18, 2021, while others will come into force on the date that the IO expires.
These amendments are intended as a successor to the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (IO), which is scheduled to expire on September 16, 2021. We reported on the IO and the government’s consultation regarding its transition plan last year.
The following is a general summary of some of the highlights from the amendments discussed in the Regulatory Impact Analysis Statement. Health Canada has also published a guidance document that contains additional information for drug sponsors.
Continued authorization for COVID-19 drugs
The FDR amendments provide a pathway for COVID-19 drugs, whether previously authorized under the IO or not, to be authorized under the FDR. A COVID-19 drug will now be subject to the requirements in Part C, Division 8 of the FDR and approvable via a new drug submission (NDS) or supplemental new drug submission (SNDS) that can result in a NOC.
The FDR amendments include some of the flexibilities for COVID-19 drug NDSs that were previously available for direct filings under the IO, such as exemptions from certain submission requirements and the ability to complete the submission as data becomes available (also known as rolling submissions). These flexibilities are not extended to SNDSs.
Two other approval pathways that were available under the IO (i.e., (i) an approval predicated on the prior authorization by a foreign regulatory authority, and (ii) a mechanism to expand indications of Canadian-approved products) have not been extended to these amendments.
COVID-19 drug authorizations must be regularized by filing an NDS or SNDS and obtaining an NOC in order to be maintained. The NDS or SNDS must generally be filed within:
- 90 days following the coming into force of the amendments, if the holder received authorization prior to the regulatory amendments coming into force; or
- 90 days following issuance of an IO authorization, if the holder receives authorization after the regulatory amendments come into force.
The amendments provide for the circumstances under which IO authorizations will be maintained or revoked throughout the regularization process.
Terms and conditions on DINs
As in the IO, the FDR amendments permit the Minister to impose terms and conditions on a DIN where the manufacturer has relied on certain flexible safety and efficacy requirements available for an NDS under the amendments. These could include specific pharmacovigilance and risk mitigation and management measures, additional quality information, confirmation of effectiveness, and measures for the purpose of preventing or alleviating a shortage.
Intellectual property considerations
Filing a submission and obtaining an NOC under the FDR amendments may allow the manufacturer to benefit from intellectual property protections associated with the submission process, including patent listing under the Patented Medicines (Notice of Compliance) Regulations and access to the Certificate of Supplementary Protection regime, as well as data protection for innovative drugs under the FDR. The amendments clarify that for the purpose of determining innovative drug status, a COVID-19 drug is not considered to have been previously approved on the basis of an IO authorization.
Subsequent-entry (i.e., generic and biosimilar) versions of COVID-19 drugs authorized under the IO have been permitted only in order to address potential shortages. Any such authorizations will expire with the IO.
Once a reference COVID-19 drug has received an NOC under the FDR, the usual pathways for approval of subsequent-entry products based on a comparison to the approved reference product are available.
Drug establishment licensing
The FDR amendments maintain a flexible licensing approach for drug establishment licensing for activities related to COVID-19 drugs following expiry of the IO. Similar to the IO, the amendments require the Minister to consider the public health need when deciding whether to issue or amend an applicant’s DEL. The Minister’s broad authority to impose or amend terms and conditions on these DELs is also maintained. The new provisions are now enforceable under s. 21.7 of the Food and Drugs Act.
The FDR amendments continue to permit the “pre-positioning” of COVID-19 drugs by allowing early importation prior to receiving an NOC under certain circumstances. As in the IO, COVID-19 drugs will only be eligible for pre-positioning if the Government of Canada has entered into a contract with the manufacturer to procure it, the Chief Public Health Officer of the Public Health Agency of Canada has notified the Minister of the COVID-19 drug to be pre-positioned, and the importer holds a DEL. Once the drug receives market authorization in Canada, regular DEL requirements apply to subsequent importation and distribution.