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Presentation: Prescription medicine registration process performance

TGA presentations: ARCS Scientific Congress Canberra, 10-11 August 2016

18 August 2016

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Presentation

  • Presented by: Dr Paul Huleatt
  • Presented at: ARCS Scientific Congress Canberra
  • Presentation date: 10-11 August 2016
  • Presentation summary: 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.

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, 10-11 August 2016

Slide 1 - 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

Slide 2 - 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.

Slide 3 - Background

A line graph displaying the volume of submissions by quarter from November 2010 to June 2016.

Since the July 2014 batch

775PPFs 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%)

Slide 4 - Background

A bar graph displaying the Submissions on Hand  of Category 1 and Other submissions.

Graph displaying Submissions on Hand.

Graph displaying Net Submissions In/Out from 3 May 2016 to 27 July 2016.

Slide 5 - Streamlined submission process

From inception until June 2013

This is the original SSP. There is a single workflow for all category 1 applications. Round 1 evaluation length was for 4 or 5 months based on the size and complexity of the dossier determined during screening prior to milestone 1 (e.g. regular dossier would have a 4 month round 1, a large dossier, e.g. greater than 200/300 volumes of Module 5 data would have a 5 month round 1). Typically not all evaluation reports (module 3 evaluations excepted) were provided to the applicant when the consolidated S31 request was made at Milestone 3. The round 2 evaluation phase was 1 month and all final evaluation reports provided at this point. An ACPM cycle was included for all category 1 applications regardless of the submission being referred to the committee or not. The decision was due at the end of the month in which the ACPM meeting was held and registration (Milestone 8) was at the end of the following month.

Slide 6 - Streamlined submission process

All Category 1 Submissions except new generic medicines - July 2013 batch onwards

New generic medicines workflow - July 2013 batch onwards

Slide 7 - Streamlined submission process

All Category 1 Submissions except new generic medicines - July 2013 batch onwards

Following the business rule changes, all category 1 submissions except generics were given a standard 5 month first round of evaluation. Frist round evaluation reports from every evaluation area were then routinely provided with the consolidated S31 request was made at Milestone 3. Round 2 remained 1 month in duration, however, final evaluation reports were no longer sent at Milestone 5 but were sent with the delegates overview (~1 or 2 months after milestone 5). Sponsor's notification of errors of fact or omission in relation to the evaluation report was then due back to the TGA at the same time as their pre-ACPM response to the delegate's overview. The decision date was moved to 6 weeks from the ACPM meeting to accommodate the time required for post-ACPM negotiations and the registration date was made 6 weeks after that.

Slide 8 - 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

Slide 9 - 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.

Slide 10 - 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)

Slide 11 - 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.

Slide 12 - Benchmarking performance - New generic medicines

Approval times shown in calendar days

Time from 'effective' to 'decision'
Analysis Performed Registration Process Number of Type D Submissions Approved Average Median Minimum Maximum
June 2015 Pre-PBR 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

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.

Slide 13 - 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

Slide 14 - 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

Slide 15 - 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.

Slide 16 - 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.

Slide 17 - Type A Submissions

A series of pie charts displaying time frames for Type A submissions for Milestone 3, Milestone 5, ACPM, Milestone 7 and Milestone 8.

Slide 18 - 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.

Slide 19 - 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)

Slide 20 - 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.

Slide 21 - New Generic Medicines

A series of pie charts displaying time frames for New Generic Medicines for Milestone 3, Milestone 5, ACPM, Milestone 7 and Milestone 8.

Slide 22 - 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.

Slide 23 - 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

Slide 24 - Case management and enabling tools

Support for applicants

Slide 25 - 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

Slide 26 - 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)

Slide 27 - Pre-submission Pilot vs standard process

Comparative submission timelines

Diagram showing the Pre-submission Pilot vs standard process: Comparitive submission timelines.

Slide 28 - 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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