Transcript Access - CADTH

Regulatory & Reimbursement
Harmonization
April 11, 2016
Objectives
•
The Board of Innovative Medicines Canada adopted a new set
of focused organizational objectives centered on:
•
Clinical
Development
Improving Access to medicines for patients
Regulatory
Approval
Health
Technology
Assessment
Access
4
Average days to NOC – Health Canada
1500
1200
900
600
300
Post-NOC environment
is more complicated
0
1987
1992
1997
2002
2007
2012
Source: Innovative Medicines Canada, HC Performance Reports
5
Improving Access to Medicines
Clinical
Development
Regulatory
Approval
Health
Technology
Assessment
Access
Natural Option for Consideration
Clinical
Development
Regulatory
Approval
Health
Technology
Assessment
Access
6
Adjust how we measure
•
NOC/c
•
Priority Review
•
Progressive Licencing – 2007
•
Drug for Rare Diseases – 2012
•
C-17 – 2014
7
NOC/c
Number of NOC/c
20
18
16
14
12
10
8
6
4
2
0
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
8
Progressive Licencing
Today
Point-in-Time Approach
Future
Life-Cycle Approach
9