Prescription medicine registration process performance · 2016-08-17 · Prescription medicine...
Transcript of Prescription medicine registration process performance · 2016-08-17 · Prescription medicine...
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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
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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
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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)
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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
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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
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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
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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
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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
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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.
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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)
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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.
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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.
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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
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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
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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.
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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.
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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
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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
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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)
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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.
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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
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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.
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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
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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
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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
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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
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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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