Market Authorization of Drugs Under the Food and Drug Regulations
| Author | T. Nessim Abu-Zahra/Simon Carvalho/David Edwards |
| Pages | 23-60 |
THREE
Market Authorization of Drugs Under
the Food and Drug Regulations
A. OVERVIEW
As explained in Chapter , the denition 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-
sication 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
identication number (DIN) and a notice of compliance (NOC). Specic-
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 proles,
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
objectives.
The Regulation of Drugs in Canada
However, the requirements are dierent for “new drugs.” As explained
below, a “new drug” is one that has not been sold for sucient time and in
sucient quantity in Canada to establish its safety and eectiveness. 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
denition 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 diers for products that fall within
the denition of “new drug” and those that do not. For those DIN-only
products that do not fall within the denition 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
B. DRUG SUBMISSION AND NOC UNDER DIVISION 8
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 dened in section of the FDA (see Chapter ). Specically,
C.. of the FDRs denes “new drug” as a drug that consists of a sub-
stance that has not been sold in Canada for “sucient time and in
sucient quantity” to establish its safety and eectiveness as a drug.
Additionally, the “new drug” denition captures () a drug that is a
combination of drugs that have not been sold in Canada for “sucient
time and in sucient quantity” to establish the safety and eectiveness
of that combination or () a drug sold for a therapeutic purpose that
has not be sold in “sucient time and in sucient quantity” to estab-
lish the safety and eectiveness 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 “sucient” as follows:
I am satised that the use of the word “sucient” 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 satised as to safety and ecacy. e word
“sucient” implies a standard that may be variable, depending upon the
circumstances. eConcise Oxford Dictionary denes the word in say-
ing“sucing, adequate esp. in amount or number to the need, enough”.It
is appropriate for HealthCanada, 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 “sucient” in and of
itself to determine safety and ecacy. In this case, HealthCanadadeter-
mined that such suciency did not exist. I nd no reviewable error in that
determination. HealthCanada’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 classied
as “prescription drugs” because the supervision of a practitioner is necessary
Wellesley erapeutics Inc v Canada (Health), FC at para [Wellesley
erapeutics].
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