Proposed Plan for

the Future of DEL

& GMP Regulatory
Flexibilities

Health Canada

Proposed Plan for the Future of DEL & GMP Regulatory Flexibilities 1|Page
Table of Contents
Background ....................................................................................................................................................................... 3
Proposal – Future of DEL and GMP Regulatory Flexibilities ........................................................................... 4
Foreign evidence regulatory flexibilities ............................................................................................................ 4
Extending new evidence requirement by (NERBY) dates for foreign buildings ............................. 4
Extending foreign evidence validity periods ............................................................................................... 5
Accepting corporate/consultant audit reports to demonstrate GMP compliance of foreign
buildings .................................................................................................................................................................... 5
Domestic testing ......................................................................................................................................................... 6
Deferral of confirmatory testing ....................................................................................................................... 6
Modified identity testing..................................................................................................................................... 7
Quality risk assessment regulatory flexibilities ................................................................................................ 8
Deferring minor or low-risk investigations for drugs with a shortage concern ............................. 8
Using electronic signatures that are not fully validated.......................................................................... 8
Future Health Crisis Response.................................................................................................................................... 9
Next steps .......................................................................................................................................................................... 9
Contact Information ....................................................................................................................................................... 9
Annex: Proposed plan at a glance ......................................................................................................................... 10

Proposed Plan for the Future of DEL & GMP Regulatory Flexibilities 2|Page
Background
In March 2020, the World Health Organization declared a global pandemic related to severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2), commonly known as COVID-19. The
COVID-19 pandemic created an unprecedented demand on Canada's health care system,
directly affecting the pharmaceutical sector. Urgent and immediate action was necessary to
minimize disruptions of the global drug supply chain and importation of drug products into
Canada. Over the course of the pandemic, Health Canada has aimed to ease the regulatory
challenges facing the pharmaceutical industry.

Health Canada introduced a number of regulatory flexibilities for Drug Establishment Licences
(DEL) and Good Manufacturing Practices (GMP) in response to challenges created by the global
pandemic, and to safeguard the timely access to high quality drug products for the people of
Canada.

The DEL and GMP regulatory flexibilities related to licensing and inspection of health products
include:
• Foreign evidence
o Extending new evidence requirement by (NERBY) dates for foreign buildings
o Accepting corporate/consultant audit reports to demonstrate GMP compliance of
foreign buildings
o Extending foreign evidence validity periods (from 3 years to 5 years)

• Domestic testing
o Deferring confirmatory testing for drugs imported from non-Mutual Recognition
Agreement (MRA) countries
o Modifying identity testing requirements for drugs imported from non-MRA countries

• Quality risk management

o Deferring minor or low-risk investigations for drugs with a shortage concern
o Using electronic signatures that are not fully validated

In January 2022, Health Canada solicited industry feedback, using an anonymous online
questionnaire, about the state of the pharmaceutical industry in maintaining business operations
during the pandemic and the usage and usefulness of the available flexibilities. Over half of
active DEL holders responded, representing all licensable activities. In general, respondents felt
the flexibilities were successful in helping to mitigate some challenges and would like Health
Canada to adopt certain flexibilities as part of normal regulatory operations.

While the flexibilities were initially intended to be a temporary measure, Health Canada
recognizes the benefits of having certain flexibilities available to respond to emergency
situations and supply chain disruptions (i.e., drug shortages). In determining the future use of
these flexibilities, Health Canada’s review considered the current state of the industry, supply
chains, stakeholder perspectives, alignment with our international regulatory partners and future
health crises preparedness.

Proposed Plan for the Future of DEL & GMP Regulatory Flexibilities 3|Page
Proposal – Future of DEL and GMP Regulatory Flexibilities
The purpose of this plan is to provide timelines and scope of use for DEL and GMP regulatory
flexibilities. Health Canada will continue to monitor the current state of the industry and adjust
the plan, as necessary.

Foreign evidence regulatory flexibilities

Regional restrictions and isolation measures caused the deferral of onsite inspections by most
regulatory authorities across the globe. This affected the availability of recent GMP evidence to
support the addition or renewal of manufacturing sites on DELs.

To address this, Health Canada introduced several flexibilities related to foreign evidence
requirements.

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

Normal practice Summary of the flexibility
NERBY dates are assigned to foreign Health Canada granted extensions for all
buildings conducting activities related to New Evidence Required By (NERBY) dates.
finished dosage forms and follow a four-
year inspection cycle using a risk-based
approach.

Proposal and transition

Reinstate NERBY dates as per normal practice, taking a phased approach to allow DEL holders to
transition back to normal cycle of providing new evidence for foreign buildings.

This flexibility will no longer be available as of August 1, 2023, with a phased transition period
until May 1, 2025.

A fixed transition NERBY date will be assigned based on the date of expiry.
When did the FB Expire Fixed Transition NERBY Date

< December 2020 August 1, 2023

January 2021 – June 2021 January 1, 2024
July 2021 – December 2021 May 1, 2024
January 2022 – June 2022 August 1, 2024
July 2022 – December 2022 January 1, 2025
January 2023 – July 2023 May 1, 2025

DEL holders with expired foreign buildings will be required to either:

• submit new evidence, as per normal process and expectations; or,
• submit a request to seek an extension.

Proposed Plan for the Future of DEL & GMP Regulatory Flexibilities 4|Page
DEL holders that have new GMP evidence available before the fixed transition NERBY date
should submit it as soon as possible.

DEL holders who do not submit new evidence or submit a request for extension by
their fixed transition NERBY date will undergo the regular foreign building removal
process from their DEL.

Requesting a NERBY extension: Health Canada will be introducing an updated

way to request an extension to the NERBY date for a foreign building. The NERBY
Extension Request Form will facilitate the transition of the NERBY flexibility so that
DEL holders return to normal evidence cycles. Details about the new NERBY
extension process are included in this consultation package.

Extending foreign evidence validity periods

Normal practice
Importers must submit evidence of GMP
compliance (i.e., final inspection report
conducted by a trusted foreign regulator)
issued within the last three years to add or
maintain foreign buildings on their DEL.
Summary of the flexibility
Health Canada extended the validity period
of inspection reports conducted by trusted
foreign regulators from three years to five
years.

Proposal and transition

Extended validity periods for evidence of GMP compliance will remain in place until December
31, 2023; however, DEL holders are encouraged to submit evidence that is within the last three
years when possible.

This flexibility will no longer be available as of January 1, 2024, and DEL holders will be expected
to submit evidence of GMP compliance with the last three years.

Accepting corporate/consultant audit reports to demonstrate GMP compliance of

foreign buildings
Normal practice
Health Canada only considers
corporate/consultant audit reports for
foreign buildings sterilizing packaging
materials for drugs that will be aseptically
filled without terminal sterilization, and
foreign buildings fabricating,
packaging/labeling, or testing:
• over the counter (OTC) drugs
• medical gases
• ethical drugs
Summary of the flexibility
Health Canada considered
corporate/consultant audits to demonstrate
foreign building GMP compliance for all
activities and product types, on a case-by-
case basis, where there was no other means
available to obtain GMP evidence for a
foreign building.

Proposed Plan for the Future of DEL & GMP Regulatory Flexibilities 5|Page
Proposal and transition
Continue to consider corporate/consultant audits to demonstrate foreign building GMP
compliance for all activities and product types, on a case-by-case basis, until December 31,
2023.

When considering a corporate/consultant audit, Health Canada takes into account the following
risk-based criteria:
• nature of the product (i.e., if the product is medically necessary)
• compliance history of the foreign building
• the method of audit (i.e., remote or onsite)
• whether there is other evidence available from a regulatory/qualified authority

This flexibility will no longer be available as of January 1, 2024 and Health Canada will only
consider corporate/consultant audit reports as outlined in Guidance: How to demonstrate
foreign building compliance with drug good manufacturing practices (GUI-0080).

Domestic testing
Some Canadian importers were unable to access testing facilities and meet confirmatory testing
requirements (i.e., testing to confirm drug product meets specifications) due to staffing issues
and laboratory testing capacity constraints because of the pandemic.

To ensure the people of Canada had continued access to the medications they rely upon,
flexibilities were introduced to prevent delays in the release of product to the Canadian market,
specifically those imported from countries with whom Canada does not have a MRA.

Deferral of confirmatory testing

Normal practice
All importers of drugs from countries with
whom Canada does not have a MRA, are
required to conduct periodic confirmatory
testing of the drugs they import (i.e., as per
C.02.019 of the Food and Drug Regulations).
Summary of the flexibility
Health Canada allowed licensed importers
to defer periodic confirmatory testing
requirements if unable to conduct such
tests, provided all other product release
requirements were met.

Proposal and transition

This flexibility is modified to permit deferral of periodic confirmatory testing by importers of
drugs from qualified authority’s jurisdictions (i.e., a member of the Pharmaceutical Inspection
Cooperation/Scheme [PIC/s]) if unable to conduct such tests prior to planned release, provided
all other product release requirements are met. This modified flexibility is available until
December 31, 2023.

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Confirmatory testing must be completed within three months of the product released to the
market.

Importers of drugs imported from countries who are not from qualified authority’s jurisdiction
are required to conduct period confirmatory testing.

This flexibility will no longer be available as of January 1, 2024.

There are existing exemptions from this requirement that are outlined in the Food
and Drug Regulations (C.02.019): drugs imported from a country with whom
Canada has a MRA, and COVID-19 drugs if subject to a written request made
under section C.04.015 (lot release program).

Modified identity testing

Normal practice Summary of the flexibility
All importers of drugs from countries with Health Canada allowed licensed importers
whom Canada does not have a MRA, are to modify current unique identifier
required to conduct identity testing of the principles to confirm the imported drug’s
drugs they import (i.e., as per C.02.019 of identity to include:
the Food and Drug Regulations). • a visual inspection of the labelling on
samples of product taken from each batch
received against approved product
labelling
• a visual comparison of the drug in dosage
form against that of previously retained
samples or other comparative information
• an application of physical measurements
(dimensions, volume) of a sample of the
drug in dosage form.
Proposal and transition
This flexibility is modified to permit modified unique identifier principles for identity testing by
importers of drugs from qualified authority’s jurisdictions (i.e., a member of PIC/S) if unable to
conduct such tests prior to planned release. This modified flexibility is available until December
31, 2023.

Importers of drugs imported from countries who are not from qualified authority’s jurisdiction
are required to conduct identity testing as per normal practice.

This flexibility will no longer be available as of January 1, 2024.

Proposed Plan for the Future of DEL & GMP Regulatory Flexibilities 7|Page
Quality risk assessment regulatory flexibilities
The pandemic created several challenges, including limited availability of staff and contract
service providers onsite. This restricted the work that could be performed and affected the
ability to perform services, such as software validation.

Health Canada recognized the drug product industry needed to adjust its operations
temporarily to address pandemic challenges. By applying good quality risk management (QRM)
principles, industry was able to maintain product safety and manufacturing standards.

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

Normal practice Summary of the flexibility
All investigations involved with each batch Companies were permitted to defer the
are to be completed before the release of completion of minor or low-risk
the product to the Canadian market. investigations (e.g., investigations that have
no product quality impact), as to avoid
holding up batches of products with
shortage concerns and to prevent delays in
the release of products to the Canadian
market.
Proposal and transition
This flexibility is modified so that only products in actual shortage (i.e., published shortage
report on drugshortagescanada.ca) can defer minor or low-risk investigations as to prevent
delays in the release of the products to the Canadian market. The flexibility will remain available
until December 31, 2023. DEL holders are encouraged to complete all investigations before the
release of the product to the Canadian market.

This flexibility will no longer be available as of January 1, 2024.

Using electronic signatures that are not fully validated

Normal practice
Electronic signature systems must be
qualified and validated before use.
Proposal and transition
This flexibility will return to normal practice. As of August 1, 2023, electronic signature systems
must be qualified and validated before use.
Summary of the flexibility
So long as steps were taken to ensure
authenticity, Health Canada permitted the
use of electronic systems that did not fully
meet electronic signature controls. There
was also a requirement to qualify and
validate these electronic systems as soon as
reasonably possible.

Proposed Plan for the Future of DEL & GMP Regulatory Flexibilities 8|Page
Future Health Crisis Response
Building from our experience during the COVID-19 pandemic, Health Canada is strengthening
its emergency preparedness capabilities to facilitate efficient and effective response to future
health crises.

While the GMP and DEL flexibilities were intended to be a temporary measure in response to the
unique challenges presented by the COVID-19 pandemic, Health Canada recognizes the benefits
of having certain flexibilities available to respond to emergency situations and supply chain
disruptions (i.e., drug shortages).

On a case-by-case basis, Health Canada will allow temporary measures to address immediate
issues while maintaining oversight and safeguarding health and safety. This is normally reserved
for shortages and medically necessary health products; however, it could also be applied to
supply chain disruptions that are caused by climate events and crises in key manufacturing
areas.

Next steps
Health Canada invites DEL holders and industry stakeholders to submit feedback on this
proposed plan by April 3, 2023.

Health Canada will provide advance notification to impacted regulated parties when this plan is
final and in force.

Contact Information
You may direct any questions or comments about this proposal to:

Health Products Inspection and Licensing Division

Email: del.questions-leppp@hc-sc.gc.ca

Proposed Plan for the Future of DEL & GMP Regulatory Flexibilities 9|Page
 Annex: Proposed plan at a glance
Below is a summary of Health Canada’s proposal for the future of each regulatory flexibility,
transition plan and associated timelines for implementation.

Proposal Expectations Timelines

Extending new evidence requirement by (NERBY) dates for foreign buildings
Reinstate NERBY dates and A phased approach to transition DEL The flexibility is no longer
return to normal cycle of holders back to normal cycle of available as of August 1, 2023,
providing new evidence for providing new evidence for foreign with a phased transition period
foreign buildings. buildings. until May 1, 2025.

DEL holders that have new GMP

evidence available before the Fixed
Transition NERBY Date should submit
it as soon as possible.
Extending foreign evidence validity period
Foreign Evidence

Continue to allow extended DEL holders can submit evidence of Flexibility to remain in place until
validity periods for evidence of GMP compliance issued within the last December 31, 2023.
GMP compliance; however, DEL five years to add or maintain buildings
holders are encouraged to on their DEL. As of January 1, 2024, DEL holders
submit evidence that is within will be expected to submit
the last three years when evidence of GMP compliance with
possible. the last three years.

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

Continue to consider, on a DEL holders can submit certain Flexibility to remain in place until
case-by-case basis, corporate/consultant audits to December 31, 2023.
corporate/consultant audits to demonstrate foreign building GMP
demonstrate foreign building compliance, on a case-by-case basis, As of January 1, 2024, Health
GMP compliance for all where there is no other means Canada will only consider
activities and product types. available to obtain GMP evidence for corporate/consultant audit
a foreign building. reports as outlined in GUI-0080.

Deferral of confirmatory testing

Modify to only permit deferral
of confirmatory testing by
importers of drugs from PIC/s
jurisdictions, if unable to
conduct such tests.
Domestic testing
Deferred confirmatory testing must be
completed within three months of the
product released to the market.
Importers of drugs imported from
countries who are not from qualified
Modified flexibility available until
December 31, 2023.
This flexibility will no longer be
available as of January 1, 2024.

authority’s jurisdiction are required to

conduct periodic confirmatory testing
as per normal practice.

Modified identity testing

Modify to only permit modified Importers of drugs imported from Modified flexibility available until
unique identifier principles by countries who are not from qualified December 31, 2023.
importers of drugs from PIC/s authority’s jurisdiction are required to
jurisdictions, if unable to conduct identity testing as per This flexibility will no longer be
conduct such tests. C.02.019 of the Food and Drug available as of January 1, 2024.
Regulations.
Deferring low-risk investigations for drugs with a shortage concern
Modify so that only products in DEL holders are encouraged to Modified flexibility available until
Quality risk management

actual shortage (i.e., published complete all investigations before the December 31, 2023.
shortage report on release of the product to the
drugshortagescanada.ca) can Canadian market. This flexibility will no longer be
defer minor or low-risk available as of January 1, 2024.
investigations. Unless the drug product is in actual
shortage, DEL holders must complete
all investigations before the release of
the product to the Canadian market.
Using electronic signatures that are not fully validated
Electronic signature systems must be Flexibility no longer available as
Return to normal practice. qualified and validated before use. of August 1, 2023.

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