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Presentation: Prescription medicine registration process performance

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TGA Australia
TGA Australia

The presentation provides an update on the streamlined submission process, five years on, including the evolution of the milestone-based process from inception to the present day, and opportunities for future improvements.

Health & 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
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. 2
Background Volume of Submissions by Quarter (Nov-2010 to Jun-2016) 0 20 40 60 80 100 120 140 Total A B C D F J 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%) 3
Background Relative Submission Volumes 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 1100 1150 1200 1250 1300 1350 SubmissionsonHand -80 -60 -40 -20 0 20 40 60 NetSubmissionsIn/Out -80 -60 -40 -20 0 20 40 60 NetSubmissionsIn/Out
Streamlined submission process From inception until June 2013 MS2 MS3MS1 MS4 MS5 MS7 MS8ACPM 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 MS3MS1 MS4 MS5 MS7 MS8ACPM 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 MS3MS1 MS4 MS5 MS7 MS8 4 months 6 weeks 6 weeks2 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 • Process Support: Case management and Enabling Tools • New initiatives: A simplified pre-submission phase 23
Case management and enabling tools Support for applicants • Dedicated staff – 1 case manager per stream • On-going support throughout the registration process (streamlinedsubmission@tga.gov.au) • 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) 24
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 28
Presentation: Prescription medicine registration process performance

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Presentation: Prescription medicine registration process performance

  • 1. 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
  • 2. 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
  • 3. 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. 2
  • 4. Background Volume of Submissions by Quarter (Nov-2010 to Jun-2016) 0 20 40 60 80 100 120 140 Total A B C D F J 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%) 3
  • 5. Background Relative Submission Volumes 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 0 100 200 300 400 500 600 700 800 900 Category 1 Other SubmissionsonHand 1100 1150 1200 1250 1300 1350 SubmissionsonHand -80 -60 -40 -20 0 20 40 60 NetSubmissionsIn/Out -80 -60 -40 -20 0 20 40 60 NetSubmissionsIn/Out
  • 6. Streamlined submission process From inception until June 2013 MS2 MS3MS1 MS4 MS5 MS7 MS8ACPM Delegate’s Overview 4-5 months ~ 2-3 months 3 weeks 1 month MS6
  • 7. Streamlined submission process All Category 1 Submissions except new generic medicines - July 2013 batch onwards MS2 MS3MS1 MS4 MS5 MS7 MS8ACPM Delegate’s Overview 5 months 6 weeks 6 weeks~ 2-3 months MS6
  • 8. Streamlined submission process New generic medicines workflow - July 2013 batch onwards MS2 MS3MS1 MS4 MS5 MS7 MS8 4 months 6 weeks 6 weeks2 months
  • 9. 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
  • 10. 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
  • 11. 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
  • 12. 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
  • 13. 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
  • 14. 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
  • 15. 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
  • 16. 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
  • 17. 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.
  • 18. 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
  • 19. 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
  • 20. 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
  • 21. 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
  • 22. 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
  • 23. 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
  • 24. 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 23
  • 25. Case management and enabling tools Support for applicants • Dedicated staff – 1 case manager per stream • On-going support throughout the registration process (streamlinedsubmission@tga.gov.au) • 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) 24
  • 26. 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
  • 27. 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
  • 28. 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
  • 29. 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 28