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DEL and GMP temporary measures due to COVID-19

Health Canada has reviewed the good manufacturing practices and drug establishment licence temporary regulatory flexibilities we put in place during the pandemic. Our review process involves many considerations, including stakeholder feedback.

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Overview

Over the course of the pandemic, Health Canada introduced interim measures that provided regulatory flexibility for drug establishment licences (DEL) and good manufacturing practices (GMP).

In January 2022 and March 2023, we sought feedback from industry stakeholders on these measures. These measures were intended to be temporary to mitigate the impacts of the pandemic.

However, we recognize the benefits of having certain flexibilities available to respond to emergency situations and supply chain disruptions, such as drug shortages. During our review on how we can use these measures in the future, we considered stakeholder feedback as well as:

Planning for post-pandemic operations and new approaches

We have set out timelines for these measures to help DEL holders return to routine DEL and GMP processes and requirements. We have also implemented a more risk-based approach, where appropriate.

Onsite inspections have resumed to pre-pandemic levels. We will assess compliance with the applicable regulatory requirements in accordance with the following expectations. This includes taking action when we find a company is non-compliant.

Foreign evidence regulatory flexibilities

Due to regional restrictions and isolation measures, most regulatory authorities across the globe deferred onsite inspections.

Extending new evidence required by (NERBY) dates for foreign buildings

NERBY dates are assigned to foreign buildings conducting activities related to drug manufacturing. The dates normally follow a 4-year review cycle using a risk-based approach. During the pandemic, we granted extensions to drug companies for all NERBY dates.

Going forward

Regulatory authorities have resumed onsite inspections after these were postponed during the pandemic. However, as a considerable number of these inspections still need to be conducted, we are extending all expired NERBY dates until December 31, 2024. We are re-evaluating our risk-based approach to assigning NERBY dates after January 1, 2025. We will communicate any changes to the approach in 2024.

Extending foreign evidence validity periods

Importers must submit evidence of current GMP compliance (within the last 3 years) to add or maintain foreign buildings on their DEL. An example of this evidence would be a final inspection report conducted by a trusted foreign regulator.

During the pandemic, we extended the validity period of inspection reports conducted by trusted foreign regulators to 5 years.

Going forward

To provide time for inspection cycles to return to normal post-pandemic, extended validity periods for GMP evidence will remain in place until December 31, 2024. We will address any changes to evidence validity periods in the updated version of the following guidance:

We expect to publish this revised guidance in the fall of 2024.

DEL holders are expected to submit available, recent GMP evidence promptly, and not wait until December 31, 2024, to ensure timely compliance.

Accepting corporate/consultant audit reports to demonstrate GMP compliance of foreign buildings

We only consider corporate/consultant audit reports for foreign buildings that:

During the pandemic, we considered corporate/consultant audits to demonstrate foreign building GMP compliance on a case-by-case basis.

Going forward

This flexibility will remain in place until December 31, 2024. We will address any changes to the acceptance of corporate/consultant audits in the updated version of GUI-0080.

Domestic testing regulatory flexibilities

Staffing issues and laboratory testing capacity constraints resulting from the pandemic meant that some Canadian importers could not access testing facilities and meet confirmatory testing requirements.

Deferral of confirmatory testing

All importers of drugs from countries with whom Canada does not have a mutual recognition agreement (MRA) must conduct periodic confirmatory testing of the drugs they import. This is set out in section C.02.019 of the Food and Drug Regulations (regulations).

During the pandemic, licensed importers could defer periodic confirmatory testing requirements if they could not conduct such tests. However, they had to meet all other product release requirements.

Going forward

Given that access to testing services is now widely available, importers are expected to have resumed periodic confirmatory testing of the drugs they import. This includes any testing that was deferred during the pandemic. This flexibility will end on March 31, 2024.

Exemptions from this requirement are outlined in subsection C.02.019 of the regulations.

We will be updating the List of non-prescription drugs for which the testing requirements set out in subsections C.02.019 (1) and (2) of the Food and Drug Regulations do not apply . This is part of our ongoing work on modernizing the regulations. Consultations on these updates are planned for 2024.

Modified identity testing

All importers of drugs from countries with whom Canada does not have an MRA must conduct identity testing of the drugs they import. This is set out in section C.02.019 of the regulations.

As an interim measure, we allowed licensed importers to modify current unique identifier principles to confirm the imported drug's identity.

Going forward

Importers are expected to conduct identity testing of the drugs they import as per the regulations. This flexibility will end on March 31, 2024.

Quality risk management regulatory flexibilities

The pandemic limited availability of staff and contract service providers onsite. This limited the work that could be performed and affected the ability to carry out some process controls.

Deferring minor or low-risk investigations for drugs with a shortage concern

All investigations involving each batch of drug are to be completed before the product is released in Canada.

As a temporary measure, companies were able to defer completing minor or low-risk investigations (for example, investigations that have no impact on product quality) to:

Going forward

This flexibility will end on March 31, 2024.

Some shortages may have critical impacts on the Canadian drug supply. We will continue to work with companies on a case-by-case basis to take necessary steps to mitigate these impacts.

Using electronic signatures that are not fully validated

Electronic signature systems must be qualified and validated before they are used.

The requirements for electronic signatures are explained in the Good manufacturing practices guide for drug products (GUI-0001).

During the pandemic, as long as steps were taken to ensure authenticity, we allowed companies to use electronic systems that did not fully meet electronic signature controls. We also required companies to qualify and validate these electronic systems as soon as they could.

Going forward

DEL holders are expected to qualify and validate electronic systems as soon as reasonably possible. This flexibility will end on June 30, 2024. After this date, electronic signature systems must be qualified and validated before they may be used.

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