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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

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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

1

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SLIDE 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

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SLIDE 4

Background

Volume of Submissions by Quarter (Nov-2010 to Jun-2016)

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%)

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Background

Relative Submission Volumes

1100 1150 1200 1250 1300 1350 Submissions on Hand

  • 80
  • 60
  • 40
  • 20

20 40 60 Net Submissions In/Out

  • 80
  • 60
  • 40
  • 20

20 40 60 Net Submissions In/Out 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand 100 200 300 400 500 600 700 800 900 Category 1 Other Submissions on Hand

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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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SLIDE 7

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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SLIDE 8

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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SLIDE 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

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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

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SLIDE 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

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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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SLIDE 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

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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.

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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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SLIDE 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.

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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 Cohort 4

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SLIDE 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.

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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

23

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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 (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) (

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SLIDE 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

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SLIDE 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)

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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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