ARCHIVED Consultation on amending the Food and Drug Regulations to expedite access to COVID-19 drugs: Notice to stakeholders

Health Canada is proposing to amend the Food and Drug Regulations to provide an application pathway for COVID-19 drugs. Stakeholders have until December 21^st, 2020, to comment on the proposed amendments.

On this page

• Purpose of the consultation
• The transition process
• About the proposed amendments
• Transition timelines
• Transition considerations
• Transition DEL and GMP
• Key questions for discussion
• Contact us

Purpose of the consultation

Health Canada developed the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 to expedite the authorization for importing, selling and advertising COVID-19 drugs during a public health emergency without compromising patient safety. This interim order (IO) introduced regulatory pathways with flexibilities in the drug authorization process. We published a notice and a guidance document to accompany the IO.

The IO expires on September 16, 2021. On this date, drugs approved through the IO will no longer be legally permitted to be sold in Canada, unless we implement transition measures.

We’re proposing to amend the Food and Drug Regulations to allow for modifications to the New Drug Submission (NDS) pathway for COVID-19 drugs. The amendments will incorporate features from the IO’s regulatory pathways, in order to continue to provide Canadians with quick access to safe and effective COVID-19 drugs. Once amended, new drug submissions can be filed under the Regulations.

Industry plays an important role in facilitating early access to these drugs. Through this consultation, Health Canada wants to make sure that stakeholders:

• are aware of the transition approach chosen to ensure COVID-19 drugs can continue to be authorized and marketed once the IO expires
• will identify any concerns they have about these proposed measures

The transition process

By amending the Regulations to include many of the same regulatory flexibilities found in the IO, sponsors will be able to:

• submit a new drug submission for review and
• receive a notice of compliance (NOC) for COVID-19 drugs authorized under the IO before it expires

These amendments provide Canadians with quick access to COVID-19 drugs without compromising safety and efficacy. Unlike the IO, data protection, the Patented Medicines (Notice of Compliance) Regulations and the Certificate of Supplementary Protection scheme apply to eligible drugs that are granted an NOC.

The period for reviewing and processing submissions and DEL applications filed under the amended Regulations for COVID-19 drugs will be expedited. These submissions would support the issuance of the NOC, along with applicable terms and conditions. Applicants will be able to add key additional information that was not available at the time of filing the submission.

Regulatory advice on this process will be contained in guidance, which will be posted as a draft once the amended Regulations are published. After the consultation period, we will release a final guidance document.

There will be flexibility for DEL applications for new licences or amendments where there is limited evidence of compliance with good manufacturing practices (GMP). Terms and conditions will be imposed to complement this flexibility, where necessary, to maintain appropriate oversight on drug quality.

About the proposed amendments

The proposed amendments will be limited to COVID-19 drugs and will involve flexibilities to Part C, Divisions 1, 1A, 2 and 8 of the Regulations. Many of the measures provided by the IO will be carried forward through amendments to the Regulations, with the exception of:

• the use of foreign decisions and expanded indications
• the authorization of generics/biosimilars to address shortages and certain GMP requirements

The proposed regulatory 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 DELs that authorizes regulated activities for COVID-19 drugs

The Regulations will be amended to include the following key components.

Notice of compliance and terms and conditions

Regulatory flexibilities introduced in the IO regarding the level of evidence required to support a new drug submission will be implemented in the Regulations,along with terms and conditions (T&C).

Proposed regulatory amendments would provide the Minister with the authority to impose and/or amend terms and conditions on COVID-19 drug identification numbers (DINs) at any time, upon authorization or while on-market.

Rolling submissions

COVID-19 drug applicants will be able to continue to use the rolling submission approach. This involves submitting a new dug submission (NDS) with limited evidence at the time a submission is filed, followed by providing new evidence when it becomes available. Applicants would still have to include a plan outlining the timing and content of incoming data packages in the case of an NDS with limited evidence. Health Canada will assess the application based on the information submitted. Terms and conditions will be applied as appropriate to satisfy approvals based on limited evidence. Submissions comparing an already approved drug, such as an NDS for a biosimilar or an abbreviated new drug submission (ANDS), wouldn’t be eligible for a rolling submission.

Pre-positioning

Through the pre-positioning mechanism, the Minister may allow the Public Health Agency of Canada (PHAC) to continue to import promising COVID-19 drugs for placement in Canadian facilities before authorization. This mechanism will be maintained after the IO expires through the following amendments to Division 8 of the Regulations:

• pre-positioning COVID-19 drugs is only possible if the federal government has entered into a contract with the manufacturer to procure it and PHAC’s Chief Public Health Officer (CPHO) has notified the Minister of the COVID-19 drug being pre-positioned
• information provided by the CPHO and the DEL holder responsible for the importation is to be consistent with the information requirements set out in the IO

DELs and GMP

Amendments to Division 1A of the Regulations would continue to allow DELs to be issued in a manner that considers the public health need of the drug. These amendments involve:

• terms and conditions imposed or amended on a DEL for a COVID-19 drug or activity at any time, to mitigate potential risks when limited evidence of GMP compliance is available at the time of issuance
  • for example, providing evidence of GMP compliance for a foreign building
• transitional provisions to allow DELs, activities and buildings to be added for an IO application even after the IO expires, to maintain minimal disruption

The modified GMP requirements for confirmatory testing and record-keeping will continue throughout the IO. Once it expires, testing requirements in C.02.019 would apply, with an exception introduced into the Regulations when the drug is subject to a written request under the Lot Release program. This exception would be similar to the one afforded when drugs are entirely manufactured and tested in Canada or in a Mutual Recognition Agreement (MRA) jurisdiction.

Cost recovery

There will be cost-recovery fees and remittances for drugs transitioning to the Regulations. As a result, we’re proposing the following, which will require some changes to the Fees in Respect of Drugs and Medical Devices Order:

• fees will be remitted in full when a company files a drug submission to transition from the IO
• existing fees will apply when a company files a drug submission for a COVID-19 drug under the revised Regulations, unless the drug was filed under the IO
• existing fees apply for subsequent filings for any supplemental new drug submission (SNDS)
• the Drug Right to Sell fee will be applicable, as per the current fee order, when a drug receives a DIN under the FDR
• existing small business mitigation measures are available for COVID-19 drug submissions, including full waiver of evaluation fee for the company’s first drug submission with Health Canada and a 50% reduction in all other evaluation fees or a 25% reduction in the Drug Right to Sell fees or Establishment Licence fees

Fee remission through the Establishment Licence Fees Remission Order (Indication of an Activity in respect of a COVID-19 Drug) only applies to DEL applications received in respect of the IO. After the IO expires, regular DEL fees will apply.

Penalties and accountability standards for COVID-19 drug submissions will stay the same as those set out in the performance standards for this order. We expect that most submissions will be processed as priority review submissions.

Similar to joint reviews, rolling submissions will not be eligible for penalties for missed performance standards (for instance, credits to sponsors). The information would be submitted according to the plan provided by the company rather than all data being submitted at the beginning, making it inappropriate to start the review clock at that time.

Post-market requirements

All COVID-19 drugs will be subject to the post-market reporting requirements under the Regulations.

Labelling

Similar to the IO, the proposed amendments to the Regulations will exclude COVID-19 drugs from brand-name assessment and a label mock-up at the time of submission. Submissions based on a comparison to an already approved drug, such as an NDS for a biosimilar or an ANDS, would not be exempt from the requirement to provide a label mock-up. The manufacturer is not expected to provide a LASA assessment for the original NDS but they are encouraged to submit it to Health Canada later.

While the intent is not to hold up the authorization of the COVID-19 drug, we encourage manufacturers to complete their LASA assessment. A T&C could be made for LASA assessment within a specified period of time.

Transition timelines

We are aiming to complete the amendments to the Regulations in 6 months following the publication of the IO. This will give manufacturers enough time to file and obtain their NOC. It will also ensure that Canadians continue to have quick access to safe and effective COVID-19 drugs.

Applicants who wish to continue selling their product will be required to file an NDS under the new pathway.

Applicants will have to file:

• within 90 days of receiving their IO authorization or
• 90 days after the amendments take effect if IO authorization was issued before this time

To avoid delays in application processing and market authorization, IO applications being reviewed when the amendments come in force will need to file under the amended Regulations pathway. Failure to file within the allotted timeframe may delay authorization.

After the transition regulations come into force, manufacturers of new COVID-19 drugs will be able to seek authorization by filing an NDS directly under the amended pathway.

Once an NOC is issued, the sponsor will be informed that the IO authorization is no longer in effect. Future filings related to the drug will be dealt with under the Regulations.

There is no end date for these amendments. We have no way of predicting how long the pandemic will last and the drugs that will be needed to address COVID-19.

Transition considerations

The amendments to the Regulations will enable COVID-19 drugs (including a drug previously approved under the IO) to apply for an NOC. Data protection, the Patented Medicines (Notice of Compliance) Regulations and the Certificate of Supplementary Protection scheme would apply to eligible drugs that are granted an NOC.

Subsequent entry drugs addressing shortages after the IO expires will not be reflected in the Regulations. Shortages will be addressed by other means. Sponsors of subsequent entry drugs will still be able to apply while respecting the timelines outlined for the existing data and patent linkage protections.

Drugs authorized under the Use of Foreign Decisions (UFD) and expanded indication provisions of the IO will no longer be available when the IO expires. The amended Regulations would contain requirements to file an NDS, with a full data package, in the case of submissions for UFDs. For expanded indications, applications for a supplement to a new drug submission (SNDS) would be filed under the existing Division 8 regulations.

If there is a continued or new need for COVID-19 drugs that were authorized under these IO pathways, the following regulatory mechanisms will continue to be available:

• Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19
• list of drugs for an urgent public health need
• authorization through a product-specific interim order or add/modify an indication by way of an interim order, as was the case during the H1N1 pandemic, if needed

Health Canada will continue to collaborate with other regulatory authorities and engage with industry stakeholders to address the urgent public health need. We will take action if we identify issues that pose a significant risk to Canadians and the health care system.

Transition for DEL and GMP

Under the transition regulations, a DEL holder whose licence was issued or amended through an application submitted under the IO will be required to notify Health Canada that they intend to continue conducting activities related to the COVID-19 drug. This would avoid the automatic cancellation of the DEL or amendments ceasing to have effect. In these cases, any terms and conditions associated with those DELs or amendments would be maintained after the IO expires.

Amendments to Division 1A will come into force when the IO expires. Until then, applicants may continue to submit a new DEL application or amendment application under subsections 20(1) and 20(2) of the IO, respectively.

The modified GMP requirements in the IO resulted from a temporary situation. They were meant to mitigate the challenges faced by industry during the early stages of the pandemic and facilitate rapid access. Health Canada has since introduced a number of measures for regulated parties to provide regulatory flexibility in regards to drug establishment licensing and compliance with GMP for all drugs.

Key questions for discussion

• Are there any comments or concerns with the implementation of these measures?
• Have you experienced challenges concerning your ability to satisfy division 2 GMP requirements, either now or in the early days of the pandemic? If yes:
  • what measures would be useful to help you overcome these challenges?
  • do you anticipate challenges in satisfying GMP requirements as the pandemic progresses?
• Are there any comments or concerns concerning the proposed approach to fees for COVID-19 drugs?

Contact us

Please contact us by email: hc.hpfb-covid19-dgpsa.sc@canada.ca.