Presentation: Prescription medicine registration process performance
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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.
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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