20160411 innovative medicines_canada_cadth_symp_panel_kmc

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Regulatory & Reimbursement Harmonization April 11, 2016

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Page 1: 20160411 innovative medicines_canada_cadth_symp_panel_kmc

Regulatory & Reimbursement Harmonization

April 11, 2016

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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

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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

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Improving Access to Medicines

Health Technology Assessment

Clinical Development

Regulatory Approval Access

Health Technology Assessment

Clinical Development

Regulatory Approval

Access

Natural Option for Consideration

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Adjust how we measure

• NOC/c

• Priority Review

• Progressive Licencing – 2007

• Drug for Rare Diseases – 2012

• C-17 – 2014

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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

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Progressive Licencing

FutureLife-Cycle Approach

TodayPoint-in-Time Approach