Quality Measures in the International Regulatory Review Process: Results of a CMR International Study

1
Registration in Major Markets
Professor Stuart Walker BSc PhD MFPM FIBiol FRSC
FRCPath FIstD Director CMR International UK
2
New Molecular Entities First Launched Onto World
Market 1990-1999
Region of first launch
IO4 0010 120100
3
Mean Development Times for NASs Launched in
1994-1998
11
61
28
with all dates available
BM2 4220 170999
4
Key Measures of Regulatory Performance
Performance
Efficiency
Quality
Efficiency and quality are inextricably bound to
each other. They are the ying and yang of both
the review process and of the process used by
industry to compile the application.
Lumpkin 1997
RG10 0370
5
Building Quality into the Regulatory Review

• QA methods in use
• Training continuing education of reviewers
• Accreditation of review practice
• Peer committee review
• Reviewer input into drug development
• Shared joint reviews
• Transparency
• Post approval analysis
• Resources
• Australia, Canada, France, Japan, Netherlands,
  Sweden, Switzerland, UK FDA

RG10 0960
6
Quality Assurance Measures Currently in Place
CDER, FDA
7
Level of Contact Reviewers Have With the Sponsor
During Both the Development and Review Process
CDER, FDA
8
Information on Review of New Drug Applications
Made Publicly Available
CDER, FDA
9
Standard Fee for a Review of a New Active
Substance
10
Resources Available to Authorities in Terms of
Full Time Equivalents
11
Proportion of Total Annual Budget Derived From
User Fees
12
Improving the Regulatory Review Process
Benchmarking
Essential strategies for future success in the
Regulatory Review
BM1 0020 210198
13
Proportion of 98 99 Approvals Granted Within
Two Years
14
Median Approval Times in Major Markets 1990-1999
PDUFA I
Evaluation User Fees
Evaluation User Fees
Procedure implemented
PDUFA II
Procedure implemented
Approval times for the MR are from the date of
application to RMS to the end of the 90-day
discussion phase.
15
Comparison of Approval Times for Priority and
Non-priority Compounds Approved in 1998 1999
? median. (n) number of applications. Box
25th and 75th percentiles Whiskers 5th and 95th
percentiles.
PDUFA II targets for 1999
90 in 12 months
30 in 10 months
90 in 6 months
16
Regulatory Approval Time for Compounds Submitted
to the USA and the EU Via the Centralised
Procedure Within 1 Month (1995-1999)