Regulating Drugs in Canada provides an overview of Health Canada's regulation of pharmaceuticals and medical devices. There are three main access streams for therapeutic products: pre-market review and approval; clinical trials for investigational testing; and special access for non-marketed products to treat serious conditions. Health Canada regulates over 14,000 marketed pharmaceutical products and 35,000 medical device licenses. The drug review and approval process has evolved significantly over time to incorporate more clinical and post-market safety data, international harmonization, and earlier access to promising new therapies for serious diseases.

1. Regulating Drugs in Canada:
An Overview
Barbara J Sabourin
Director General, Therapeutic Products
Directorate, HPFB, Health Canada
November 2015

2. Therapeutics Access Streams
Pre-market Review (Market Authorization)
• Pharmaceuticals: After receiving a Notice of Compliance and/or a
Drug Identification Number, a manufacturer/sponsor may sell a
therapeutic product in Canada (Drug Product Database)
• Medical Devices: After receiving a license, a manufacturer/sponsor
may sell a medical device product in Canada
Clinical Trials/Investigational Testing
• Qualified participants have access to experimental therapies prior
to the drug/medical device being authorized for sale to the larger
population (Clinical Trials Database)
Special Access Program
• Provides access to non-marketed drugs/medical devices for
practitioners treating patients with serious or life-threatening
conditions when conventional therapies have failed, are unsuitable,
or unavailable
2

3. Numbers of Approved Products
Pharmaceuticals*
Marketed 14,578 DINs
13,473 Human Drugs
547 Biologics
§ Rx 212
§ Non-Rx 335
12,926 Pharma
§ Rx 8,875 (8,159 RX + 716 Controlled & Narcotic)
§ Non-Rx 4,051 ( 3,152 OTC + 899 Ethical)
1,105 Disinfectants
Approved, but not marketed 5,305 (DINs)
4,829 Human drugs
154 Biologics
Rx 49
§ Non-Rx 105
4,675 Pharma
§ Rx 2,415 (2,255 RX + 160 Controlled & Narcotic)
§ Non-Rx 1,788 (1,615 OTC + 173 Ethical)
§ No schedule 472
418 Disinfectants
58 Radiopharmaceuticals
*Cumulative numbers as of Nov 13, 2015
Medical Devices**
3,670 Device Manufacturers
35,091 Active device licences
Class I – unknown, no
requirement to file
Class II – 25,480
Class III – 8,058
Class IV – 1,553
1,112,118 Catalogue numbers
**Active licenses as of November 12, 2015
3

4. Clinical
Trials
11
137
33
68
16
18
90
182
3
9
138
200
26
32
Total
317
Total
646
Total
408
0
100
200
300
400
500
600
700
BGTD
TPD
"Innovator"
TPD
"Generic"
No.
of
CTAs
Received
Clinical
Trial
ApplicaCons
Received
FY
2014-­‐15
by
class,
with
associated
number
of
sites
PHASE
OTHER
PH3
-­‐
30
DAYS
PHASE
2
/3
30
DAYS
PH2
-­‐
30
DAYS
PHASE
1
/2
-­‐
30
DAYS
PH1
OTHER
-­‐
30
DAYS
PH1
HEALTHY
HUMAN-­‐30
PH1
BIOEQUIVALENCE-­‐7
No.
of
Sites
1006
822
315
Totals
CTA
1,
371
Sites
2,143
CTA
-­‐
Amendments
1,608

5. 5
Lifecycle Approach to Regulating Drugs
5
Before Vanessa’s Law

6. Over 100 Submission
Evaluation components
1 NDS
7 SNDS
1 Admin NDS
2 Pre-SNDS meetings
2 Scientific Advisory
Meetings
2 SNDS
8 Labelling NCs
12 C&M NCs
63 CTA(-A)s
9 Post Clearance Data
12 ongoing monitoring and
communication components
6 DHPLs
4 PSUR
2 PVPs
Other interactions
- Listing of Patent on registry
Litigation (2008 - present)
Media Requests
Correspondence/Briefings
Work with Int. RAs
Life Cycle of one drug between 1998 and 2009:
Over 120 regulatory interactions
6

7. Statins submissions workload 1985-2013
Total number of ingredients = 8
Total number of submissions (all types) =
1801
• 159 brand name submissions
(NDS/SNDS)
• 235 generic submissions (ANDS/
SANDS)
Total number of DINs issued = 654
Total number of companies = 135
Total number of clinical trials (all types) =
953 (high percentage of bioequivalence studies done
by generic companies)
ANDS 204
generic
products
CTA, CTA-A,
INDS 953
clinical
trials
MPNDS/SNDS 20
submission
meeCngs
NC 416
noCfiable
changes
NDS 59
new
drug
submissions
PRNDS 1
priority
request
PSURPV 24
safety
reports
SANDS 31
Generic
supplements
SNDS 100
Brand
supplements
Grand Total 1801
Breakdown of Statin
Submissions by types

8. Earlier Access to Promising
Therapies
8
Ø Priority Review (180 days)
Provides for the "fast-tracking" of eligible New Drug Submissions (NDS)
and Supplemental New Drug Submissions (SNDS) intended for the
treatment, prevention or diagnosis of serious, life-threatening or
severely debilitating diseases or conditions for which there is
substantial evidence of clinical effectiveness
Ø Notice of Compliance with Conditions (NOCc) – (200 days)
To facilitate earlier access to a drug by physicians and patients for a
serious, life-threatening or severely debilitating disease or condition for
which there is promising evidence of clinical effectiveness
Provides the means to monitor and report on the safety and efficacy of
promising new therapies through enhanced post-market surveillance
initiatives

9. 9
Pharma Assessment process:
What information is considered?
Information provided by the sponsor (ICH, eCTD):
- Efficacy: “substantial evidence of the clinical effectiveness of the new drug for the
purpose and under the conditions of use recommended”
- Pivotal clinical studies
- Possibly also “supportive” clinical studies
- Phase I data
- Safety: “detailed reports of the tests made to establish the safety of the new drug
for the purpose and under the conditions of use recommended”
- All relevant clinical studies when at least one dose of study drug
administered
- All relevant non-clinical data
- Phase I data
- Post-marketing data if available
-Quality: chemistry and manufacturing process information
Information outside the submitted dossier (eg. Expert advice, medical literature, treatment
guidelines, info from other regulatory bodies)

10. Reviewer Competencies
10

11. A drug submission in 1960
11

12. A drug submission in 2004
12

13. A Drug Submision Now
13

14. 14
Concluding Comments
• Evaluation processes and practices continue to evolve for regulators
and stakeholders
• The goal:
• Evidence based decisions
• Transparency and cooperation among partners
• Lack of duplication
• The result: safe, effective high quality therapeutic products available to
Canadians
Thank you!