20160411 innovative medicines_canada_cadth_symp_panel_kmc
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Transcript of 20160411 innovative medicines_canada_cadth_symp_panel_kmc

Regulatory & Reimbursement Harmonization
April 11, 2016



4
Objectives
• The Board of Innovative Medicines Canada adopted a new set of focused organizational objectives centered on:• Improving Access to medicines for patients
Health Technology Assessment
Clinical Development
Regulatory Approval Access

5
Average days to NOC – Health Canada
19871988
19891990
19911992
19931994
19951996
19971998
19992000
20012002
20032004
20052006
20072008
20092010
20112012
20132014
0
300
600
900
1200
1500
Source: Innovative Medicines Canada, HC Performance Reports
Post-NOC environment is more complicated

6
Improving Access to Medicines
Health Technology Assessment
Clinical Development
Regulatory Approval Access
Health Technology Assessment
Clinical Development
Regulatory Approval
Access
Natural Option for Consideration

7
Adjust how we measure
• NOC/c
• Priority Review
• Progressive Licencing – 2007
• Drug for Rare Diseases – 2012
• C-17 – 2014

8
NOC/c
2006 2007 2008 2009 2010 2011 2012 2013 2014 20150
2
4
6
8
10
12
14
16
18
20
Number of NOC/c

9
Progressive Licencing
FutureLife-Cycle Approach
TodayPoint-in-Time Approach