Prescription medicine registration process performance The - PowerPoint PPT Presentation

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 Since the July 2014 batch Volume of Submissions by Quarter (Nov-2010 to Jun-2016) 140 775 PPFs submitted 120 100 Total 95 Type A (12.3%) A 80 13 Type B (1.7%) B 60 97 Type C (12.5%) C D 297 Type D (38.3%) 40 F J 96 Type F (12.4%) 20 162 Type J (20.9%) 0 15 Type G or H (1.9%) 3

Background Relative Submission Volumes 1350 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 900 1300 Submissions on Hand 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 800 1250 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 700 1200 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand Submissions on Hand 1150 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 1100 60 60 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 400 40 40 Net Submissions In/Out Net Submissions In/Out 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 300 20 20 0 0 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 200 -20 -20 -40 -40 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 -60 -60 -80 -80 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Category 1 Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other Other

Streamlined submission process F rom inception until June 2013 4-5 months 3 weeks 1 month ~ 2-3 months MS6 MS1 MS2 MS3 MS4 MS5 MS7 MS8 ACPM Delegate’s Overview

Streamlined submission process All Category 1 Submissions except new generic medicines - July 2013 batch onwards 5 months 6 weeks 6 weeks ~ 2-3 months MS6 MS1 MS2 MS3 MS4 MS5 MS7 MS8 ACPM Delegate’s Overview

Streamlined submission process New generic medicines workflow - July 2013 batch onwards 4 months 2 months 6 weeks 6 weeks MS1 MS2 MS3 MS4 MS5 MS7 MS8

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’ Number of Analysis Type A Performed Registration Process Average Median Minimum Maximum Submissions Approved Pre-BPR (from 2004-2010) 207 434 427 119 968 May 2015 Cohort 1 60 360 353 270 567 (Pre-business rule changes) Cohort 2 June 2016 68 360 346.5 166 713 (Post-business rule changes) 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