Market Authorization of Drugs Under the Food and Drug Regulations

AuthorT. Nessim Abu-Zahra/Simon Carvalho/David Edwards
Market Authorization of Drugs Under
the Food and Drug Regulations
As explained in Chapter , the denition of “drug” in the Food and Drugs
Act (FDA) encompasses a variety of products that are regulated under dif-
ferent sets of regulations, including the Natural Health Products Regulations
(NHPRs), the Blood Regulations, and the Food and Drug Regulations (FDRs).
e required form of marketing approval will depend on the regulatory clas-
sication of the drug in question.
With respect to those drugs that are regulated under the FDRs, there are
two relevant types of authorization permitting sale and marketing: a drug
identication number (DIN) and a notice of compliance (NOC). Specic-
ally, all drugs in dosage form that are subject to the FDRs require a DIN to
be lawfully sold. For many older drugs with well-established safety proles,
a DIN is the only form of marketing authorization needed. Examples of
such “DIN-only” products include many common over-the-counter cough
and cold and pain drugs.
RSC , c F-.
SOR/-; see Chapter .
SOR/-; see Chapter .
CRC, c .
As explained in Chapter , there also exist other authorization pathways available
under the FDRs that may permit the lawful sale of a drug for more limited pur-
poses, for example for clinical trials, emergency access for a patient, or public health
The Regulation of Drugs in Canada
However, the requirements are dierent for “new drugs.” As explained
below, a “new drug” is one that has not been sold for sucient time and in
sucient quantity in Canada to establish its safety and eectiveness. Exam-
ples of new drugs include higher-risk or less established products, such as
an injection that may be given in a cancer clinic, a medication given in
preparation for surgery, and many prescription drugs. Drugs that meet the
denition of “new drug” in the FDRs require an NOC as well as a DIN to
be lawfully sold.
In either case, the appearance of a DIN on a product’s labelling indicates
that the drug has received market authorization under the FDRs.
Although all drugs subject to the FDRs require a DIN before they can
be sold, the process for obtaining a DIN diers for products that fall within
the denition of “new drug” and those that do not. For those DIN-only
products that do not fall within the denition of “new drug,” no NOC is
needed, and the FDRs permit a DIN to be obtained based on a more limited
application. For new drugs, an NOC may be obtained by ling with the
Minister of Health a new drug submission (NDS) or, if certain conditions
are met, an abbreviated new drug submission (ANDS). e FDRs provide
that this submission also serves as an application for a DIN, such that if the
NDS or ANDS is satisfactory to the Minister, both an NOC and a DIN
will be issued without the applicant having to apply for a DIN. Furthermore,
rules exist to obtain an NOC that authorizes a change to a new drug that
has already received an NOC by way of ling a supplemental submission.
is chapter will rst describe the rules for seeking an NOC required
to sell a “new drug.” e chapter will then consider the processes for
obtaining a DIN.
is stands in contrast to those products available on the shelf marked with a natural
product number (NPN), such as vitamin C, St John’s wort, and omega- fatty acids,
which are regulated under the NHPRs (discussed in Chapter ).
Pharmascience Inc v Canada (Attorney General),  FC  at para  [Pharma-
science Inc, Trial], a’d  FCA  [Pharmascience Inc, Appeal], where the court
refers to the DIN pathway as a “less stringent drug review framework” that applies to a
“class of low-risk products.”
Market Authorization of Drugs Under the Food and Drug Regulations 
1) Overview of the NOC Scheme
Meaning of “New Drug”
Division  of Part C of the FDRs applies to “new drugs,” which are a subset
of “drugs” as dened in section  of the FDA (see Chapter ). Specically,
C.. of the FDRs denes “new drug” as a drug that consists of a sub-
stance that has not been sold in Canada for “sucient time and in
sucient quantity” to establish its safety and eectiveness as a drug.
Additionally, the “new drug” denition captures () a drug that is a
combination of drugs that have not been sold in Canada for “sucient
time and in sucient quantity” to establish the safety and eectiveness
of that combination or () a drug sold for a therapeutic purpose that
has not be sold in “sucient time and in sucient quantity” to estab-
lish the safety and eectiveness of that therapeutic purpose.
In the context of a judicial review involving the Minister’s deter-
mination that a particular drug was a “new drug,” such that it could
not be sold without rst obtaining an NOC, the Federal Court has
articulated the meaning of “sucient” as follows:
I am satised that the use of the word “sucient” in section C.. of
the Regulations does not mean that the simple passage of a long period
of time or administration of a great many doses in and of itself dictate
that the Minister must be satised as to safety and ecacy. e word
“sucient” implies a standard that may be variable, depending upon the
circumstances. eConcise Oxford Dictionary denes the word in say-
ing“sucing, adequate esp. in amount or number to the need, enough”.It
is appropriate for HealthCanada, as the need arises including, as in the
present circumstances, when it becomes expedient to do so, to make an
assessment as to whether the time and quantity is “sucient” in and of
itself to determine safety and ecacy. In this case, HealthCanadadeter-
mined that such suciency did not exist. I nd no reviewable error in that
determination. HealthCanada’s decision was reasonable.
It is important to note that “new drug” is not synonymous with “pre-
scription drug.” Rather, as explained in Chapter , certain drugs are classied
as “prescription drugs” because the supervision of a practitioner is necessary
Wellesley erapeutics Inc v Canada (Health),  FC  at para  [Wellesley

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