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Regulating Drugs in Canada: An Overview
Barbara J Sabourin Director General, Therapeutic Products Directorate, HPFB, Health Canada November 2015
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
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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
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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 C
TAs R
eceived
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
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Lifecycle Approach to Regulating Drugs
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Before Vanessa’s Law
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
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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
Earlier Access to Promising Therapies
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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
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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)
Reviewer Competencies
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A drug submission in 1960
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A drug submission in 2004
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A Drug Submision Now
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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!
