prescription medicine registration process performance · 2016-08-17 · prescription medicine...
TRANSCRIPT
Prescription medicine registration process performance The milestone-based process 2010 - 2016
Dr Paul Huleatt Business Review and Reporting Section Prescription Medicines Authorisation Branch Medicines Regulation Division, TGA ARCS Scientific Congress Canberra 2016
11 August 2016
Overview The prescription medicine registration process
• Background
• Process Performance Part 1: Timeliness and Predictability
• Process Performance Part 2: Milestone Analysis
• Process Support: Case management and Enabling Tools
• New initiatives: A simplified pre-submission phase
1
Background The prescription medicine registration process • In 2010 the TGA, in consultation with industry introduced a series of Business Process Reforms (BPR)
that aimed to introduce predictability and improve the timeliness of the registration of prescription medicines.
• A commitment was also made to increase the transparency of the TGA’s internal practices and to
enhance communication with applicants.
• The ‘Streamlined Submission Process’ for prescription medicine category 1 and 2 submissions was introduced.
• This milestone-based process consisting of eight phases with eight milestones is intended to allow
effective planning and tracking of submissions by the TGA and applicants. • The process is underpinned by business rules, mandatory requirements and legislated timeframes.
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Background Volume of Submissions by Quarter (Nov-2010 to Jun-2016)
0
20
40
60
80
100
120
140
Total
A
B
C
D
FJ
Since the July 2014 batch 775 PPFs submitted 95 Type A (12.3%) 13 Type B (1.7%) 97 Type C (12.5%) 297 Type D (38.3%) 96 Type F (12.4%) 162 Type J (20.9%) 15 Type G or H (1.9%)
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Background Relative Submission Volumes
1100
1150
1200
1250
1300
1350
Subm
issi
ons o
n H
and
-80
-60
-40
-20
0
20
40
60
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Sub
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sion
s In/
Out
-80
-60
-40
-20
0
20
40
60
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Sub
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sion
s In/
Out
0
100
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Category 1 Other
Subm
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ons o
n H
and
0
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900
Category 1 Other
Subm
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n H
and
0
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Category 1 Other
Subm
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n H
and
0
100
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Category 1 Other
Subm
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and
0
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Category 1 Other
Subm
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and
0
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Category 1 Other
Subm
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and
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Category 1 Other
Subm
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and
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Category 1 Other
Subm
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and
0
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Category 1 Other
Subm
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and
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Category 1 Other
Subm
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and
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Category 1 Other
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and
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
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and
0
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Category 1 Other
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and
0
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Category 1 Other
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and
0
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
Subm
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0
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Category 1 Other
Subm
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0
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
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Category 1 Other
Subm
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Category 1 Other
Subm
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Category 1 Other
Subm
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Category 1 Other
Subm
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ons o
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and
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Category 1 Other
Subm
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ons o
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Category 1 Other
Subm
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Category 1 Other
Subm
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Category 1 Other
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Streamlined submission process From inception until June 2013
MS2 MS3 MS1 MS4 MS5 MS7 MS8 ACPM
Delegate’s Overview
4-5 months ~ 2-3 months 3 weeks 1 month
MS6
Streamlined submission process All Category 1 Submissions except new generic medicines - July 2013 batch onwards
MS2 MS3 MS1 MS4 MS5 MS7 MS8 ACPM
Delegate’s Overview
5 months 6 weeks 6 weeks ~ 2-3 months
MS6
Streamlined submission process New generic medicines workflow - July 2013 batch onwards
MS2 MS3 MS1 MS4 MS5 MS7 MS8
4 months 6 weeks 6 weeks 2 months
Overview The prescription medicine registration process
• Background
• Process Performance Part 1: Timeliness and Predictability
• Process Performance Part 2: Milestone Analysis
• Process Support: Case management and Enabling Tools
• New initiatives: A simplified pre-submission phase
8
Benchmarking performance – Type A submissions Approval times shown in calendar days
Time from ‘effective’ to ‘decision’
Analysis Performed Registration Process
Number of Type A
Submissions Approved
Average Median Minimum Maximum
May 2015 Pre-BPR (from 2004-2010) 207 434 427 119 968
Cohort 1 (Pre-business rule changes)
60 360 353 270 567
June 2016 Cohort 2 (Post-business rule changes)
68 360 346.5 166 713
Reduction in average approval time of over 2 months
These times do not take into account the three month pre-submission and submission phases of the current process or the 40 working day screening phase of the previous process.
9
Benchmarking performance – Type A Submissions Stop Clocks
Pre-BPR (2004-2010) An average of 7 clock stops per NCE submission were applied. Combined SSP Cohorts (Type A Submissions) Of the 128 submissions: - 103 were processed with the single, planned stop clock phase (80%) - 17 submissions experienced an additional Mutual Stop the Clock (i.e. a total of 2 stop clock events) - 5 submissions were processed with two Mutual Stop the Clocks (i.e. a total of 3 stop clock events) - 3 submissions were processed with three Mutual Stop the Clocks (i.e. a total of 4 stop clock events)
10
Benchmarking performance – Extensions of indications Approval times shown in calendar days
Time from ‘effective’ to ‘decision’
Analysis Performed Registration Process
Number of Type C
Submissions Approved
Average Median Minimum Maximum
June 2016 Cohort 1 (post business rule changes)
73 331 334 187 510
Average approval time around 1 month less than for Type A submissions
These times do not take into account the three month pre-submission and submission phases of the current process.
11
Benchmarking performance – New generic medicines Time from ‘effective’ to ‘decision’
Analysis Performed Registration Process
Number of Type D
Submissions Approved
Average Median Minimum Maximum
June 2015 Pre-BPR 145 428 432 61 891
June 2016 Cohort 1 (Pre-business rule changes)
82 316 317 196 608
June 2015 Cohort 2 (Post-business rule changes)
77 297 293 210 394
February 2016 Cohort 3 74 352 301.5 217 874
June 2016 Cohort 4 60 348 291 226 802
Approval times shown in calendar days
Reduction in average approval time of over 2 months. These times do not take into account the three month pre-submission and submission phases of the current process or the 40 working day screening phase of the previous process.
12
Benchmarking performance – New generic medicines Timeframe: acceptance of the dossier for evaluation until decision
• Pre-BPR (145 submissions)
– 20% took longer than 500 calendar days – 66% took longer than 400 calendar days – 91% took longer than 300 calendar days – Average of 3 stop clock events
• Combined SSP cohorts (293 submissions)
– 6% took longer than 500 calendar days – 12% took longer than 400 calendar days – 54% took longer than 300 calendar days 13
Overview The prescription medicine registration process
• Background
• Process Performance Part 1: Timeliness and Predictability
• Process Performance Part 2: Milestone Analysis
• Process Support: Case management and Enabling Tools
• New initiatives: A simplified pre-submission phase
14
Methodology
• Planned dates were taken from the Notification Letter issued at Milestone 2.
• Actual dates were taken from the letter sent to applicant (last correspondence on record for that Milestone).
• The difference between ‘planned’ and ‘actual’ dates was determined in calendar days.
• All of the submissions included in this analysis were approved within the legislated 255 working days.
15
Analysis of performance – Type A submissions
• No notable delays were recorded at Milestones 1 and 2.
• The ACPM meeting outcomes comprise Milestone 6 and are based on the relevant ratified ACPM calendar dates. This Milestone is met with respect to the Delegate’s Overview.
• Focus on Milestones 3, 5, 7, 8 and the planned ACPM meeting.
Type A Submissions
Milestone 3 Milestone 5 ACPM Milestone 7 Milestone 8
Cohort 1
Cohort 2
Not sent to ACPM
Moved to earlier meeting
Met planned meeting
Mutually agreed deferral
Deferred due to delays
On time and early
Day after public holiday/weekend
Within 1 week
1-2 weeks
More than 2 weeks
On time and early
Day after public holiday/weekend
Within 1 week
1-2 weeks
More than 2 weeks
Comparative performance – Type A submissions Pre- and post-business rule changes
• Overall predictability of the approval date (Milestone 7) has improved.
• Delays experienced at end of evaluation rounds (Milestones 3 and 5).
• Delays at Milestone 5 reflect provision of final evaluation reports with the Delegate’s overview
• ACPM target met for 86% of submissions.
• Planned registration date now being met for >80% of submissions. 18
Analysis of performance – Type A submissions Difference between actual and planned dates
The reasons for these differences were sought and the following factors were identified:
• Applicant submits additional information (which may require a mutual stop clock)
• TGA requests additional data requiring evaluation (which may require a mutual stop clock)
• Post-ACPM negotiation (involving, for example, the PI or RMP)
19
Analysis of performance – New generic medicines
Time from ‘effective’ to ‘decision’
Registration Process Number of Type D Submissions
Approved Average Median Minimum Maximum
Cohort 1 (Pre-business rule changes)
82
316 317 196 608
Cohort 2 (Post-business rule changes)
77 297 293 210 394
Cohort 3 74 352 301.5 217 874
Cohort 4 60 348 291 226 802
• No notable delays were recorded at Milestones 1 and 2 for the generic medicines analysed. • Focus on Milestones 3, 5, 7 and 8.
20
New Generic Medicines
On time and early
Day after public holiday /weekend
Within 1 week
1-2 weeks
More than 2 weeks
Milestone 3 Milestone 5 Milestone 7 Milestone 8
Cohort 1
Pre-business rule changes
Cohort 2
Post-business rule changes
Cohort 3
Cohort 4 21
Analysis of Performance – New generic medicines Combined cohort analysis – 293 submissions
• <10% of submissions were on time or early at every milestone
• 49% of submissions were on time or early at Milestone 3
– Pre-business rule changes: 75% of submissions on time at Milestone 3 were also on time at Milestone 7 – Post-business rule changes: 49% of submissions on time at Milestone 3 were also on time at Milestone 7
• 43% of submissions were on time or early at Milestone 7
– 88% of those submissions were subsequently on time or early at Milestone 8 – 10% of those submissions were subsequently late at Milestone 8 and the average delay was 134 days.
22
Overview The prescription medicine registration process
• Background
• Process Performance Part 1: Timeliness and Predictability
• Process Performance Part 2: Milestone Analysis
• New initiatives: A simplified pre-submission phase
• Process Support: Case management and Enabling Tools
23
Case management and enabling tools Support for applicants
• Dedicated staff – 1 case manager per stream
• On-going support throughout the registration process ([email protected])
• Correspondence at all milestones, e.g. Milestone letters and evaluation reports • Evaluation plan estimation tool https://www.tga.gov.au/prescription-medicine-evaluation-plan-
estimator) (
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Overview The prescription medicine registration process
• Background
• Process Performance Part 1: Timeliness and Predictability
• Process Performance Part 2: Milestone Analysis
• Process Support: Case management and Enabling Tools
• New initiatives: A simplified pre-submission phase
25
Pre-submission Pilot - Overview • From 1 Feb 2016 until 30 September 2016
• No ‘Module 2 or equivalent’ provided with Pre-submission Planning Form
• Reduced processing time (single filter)
• No Milestone 1 planning letter
• Standard business rules apply once dossier is accepted for evaluation
• Eligible applications:
NCEs or New Generic Medicines with Version 3.0 eCTD dossier (AU specification) 26
Pre-submission Pilot vs standard process Comparative submission timelines
PPF lodgement PPF Filter Dossier Filter
Month 1 Month 2 Month 3 Month 4 Month 5
Milestone 1 Milestone 2
Dossier lodgement Evaluation
Dossier lodgement Dossier Filter
Milestone 2
PPF lodgement
15th of month
Standard Process
Pilot Process
Evaluation
Summary The prescription medicine registration process
• Background
• Process Performance Part 1: Timeliness and Predictability - Significantly improved
• Process Performance Part 2: Milestone Analysis - Clear areas for future focus
• Process Support: Case management and Enabling Tools - Key to all stakeholders
• New initiatives: A simplified pre-submission phase - Continual process improvement
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