The Government of Canada introduced amendments to the Food
and Drug Regulations (the "Regulations") and the
Patented Medicines (Notice of Compliance) Regulations
which provide an application process for the market authorization
and protection of Extraordinary Use New Drugs ("EUNDs").
These amendments took effect on March 25, 2011.
EUNDs are used to treat, mitigate or prevent a life threatening
or serious health conditions in humans which result from exposure
to a chemical, biological, radiological or nuclear substance
("CBRN Substances") in an emergency situation such a
pandemic or a terrorist attack.1
Under the Regulations, manufacturers are required to demonstrate
the safety and efficacy of a "new drug" in order to
receive market authorization in Canada. However, in most instances,
the safety and efficacy of an EUND cannot be studied in human
clinical trials prior to filing a drug submission due to time
pressures and ethical concerns. This lack of clinical evidence has
typically prevented manufacturers from meeting the requirements
needed for market authorization as a "new drug". Hence,
the sale of EUNDs was typically authorized under Health
Canada's Special Access Programme ("SAP").
The Government of Canada has determined that the SAP is not an
appropriate mechanism to regulate the sale of EUNDs for use in
pandemics or other emergencies. The amendments establish a new type
of drug submission for these products.
Under the new Regulations, a drug manufacturer may file a EUND
submission if the new drug is intended for: (a) emergency use in
situations where persons have been exposed to a CBRN Substance and
action is needed to treat, mitigate or prevent a life-threatening
or other serious disease, disorder or abnormal physical state; or
(b) preventative use in those persons who are at risk of exposure
to a CBRN Substance that is potentially lethal or permanently
The EUND manufacturer must also demonstrate that the safety of
the new drug cannot be established because: (a) exposing human
volunteers to the CBRN Substance would be potentially lethal or
permanently disabling; and (b) the circumstances in which exposure
to the CBRN Substance occur on a sporadic or infrequent basis.
If a drug substance is classified as an EUND, the manufacturer
may file a submission that is supported by: (a) certifications from
the manufacturer's senior executive officer and senior
scientific officer stating that the drug meets the EUND criteria;
(b) data from in vitro or animal studies; (c) the
drug's mechanism of action (d) draft labels; and (e) detailed
plans for post-market safety and efficacy studies etc.
EUND submissions must meet all other requirements for new drug
submissions (e.g., serious adverse reaction reporting, good
manufacturing practices, data and patent protection). Since EUNDs
are intended as countermeasures against pandemics and terrorist
attacks, these products can only be sold to federal, provincial,
territorial and municipal governments. Generic drug manufacturers
are permitted to submit abbreviated EUND submissions for products
that meet the EUND criteria. The PM(NOC) Regulations and
Data Protection Regulations have been amended to account
for new EUND and abbreviated EUND submissions.
Health Canada plans to provide a guidance document for
manufacturers in late 2011.
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