otc business process review – achievements and opportunities · otc business process review -...

OTC Business Process Review – achievements and opportunities

Dr Mayada Kayali Director, OTC Medicines Evaluation, Office of Medicines Authorisation, Market Authorisation, TGA ARCS Scientific Congress 2014

11 September 2014

Abstract • An update on the progress of the OTC BPR implementation • A look at the next steps and future plans • Common deficiencies seen in applications to date • Where should industry direct our improvement efforts with regards to submissions?

1 OTC Business Process Review - achievements and opportunities

Presenter

Presentation Notes

We commenced the OTC review activity in 2012, After extensive consultation with an industry working group (which continues), we began a gradual implementation in April 2013 Implementation is not complete, for example: The fee restructure is still to happen; And we like to think of the future as one of ‘continuous improvement’ rather than ‘completing implementation’ as if there is nothing more that can be improved.

Recap - objectives of the reforms Include: • More efficient and cost-effective evaluation processes, operating within an appropriate benefit/risk model • Greater transparency and predictability of the regulatory process • Improve the quality of OTC medicine applications lodged


Presenter

Presentation Notes

Improved quality of applications submitted And Efficient processing of applications Are inextricably linked

Recap - prior situation • Application categories very broad. (new products, variations, clones, notifications) • One process target time for all new product applications, ditto all variations • No screening upon submission, new data able to be added at any time • No limit on the number of RFIs Result: • Quality of submissions, and elapsed evaluation days, extremely variable • TGA in effect acting as pro bono consultant to some sponsors • Poor quality submissions diverting TGA effort from high quality submissions


Prior situation • Lack of clarity about expectations • Wide divergence in processing times


Presenter

Presentation Notes

The diagrams here show the impact of the situation as expressed on the previous slide While the most common result was that an application would be processes in a reasonable time, there was too high a percentage of applications that took ands excessive amount of time – some taking years ! The level of variability is a direct reflection of the variability in quality of the submissions, and showed the need for TGA internal processes that would deal better with the situation

The vision - ‘The beacon on the hill’ Perfectly clear guidelines + Perfect quality of applications

= No applications rendered ineffective = No S31 letters and associated ‘rework’ for industry and regulator = Shorter and much more predictable evaluation times

Benefits: • More efficient process for industry and regulator • Reduced time to market • More predictable product launch dates • Greater transparency of progress on the evaluation


Presenter

Presentation Notes

This ‘vision statement’ (with apologies to Ben Chifley) captures the essence of what we are striving to achieve. While we know that this is aspirational and will probably never be achieved, nonetheless it points the way to what we need to be striving for. When this was written we had not progressed to implementing our IT solution for (a) application entry and (b) work process management within the TGA. This is partly complete and refining this aspect is a major focus for us now. More on this later.

Key strategies • Establish nine risk categories for OTC medicines applications • For each category, define:

– application & data requirements – evaluation business process and clear steps within it – target times

• Require applications to be in common technical document (CTD) format (and ‘paperless’) • Upgrade the TGA IT system to:

– support better management by the TGA and industry of timelines and – remove the need for industry and regulator to deal with paper applications


Presenter

Presentation Notes

We always expected that the removal of paper applications would have benefits and cost savings to both industry and the TGA. But it has also had unexpected benefits, in enabling speedier processing of applications especially when we need to utilise and external evaluator.

Simplified table showing 5 new application pathways


Simplified table - 4 change application pathways


Key features of the process • Applications formally screened by the regulator upon receipt • Incomplete applications not accepted for evaluation • A separate target timeline specified for processing each application category • No more than two opportunities (‘RFI’s) to clarify information submitted • Applicants to be able to monitor progress of applications through online access


Presenter

Presentation Notes

Expanding the number of application categories to nine, and having a separate target time for each, has in itself created greater clarity of expectations, and predictability of results. Refining and improving that predictability remains a focus of our improvement efforts.

Overview: the new OTC medicines pre-market business process


Presenter

Presentation Notes

This is the generic work process But each of the nine application categories is a refinement of this general model, each with its own task sequence and internal target times for each step.

Screening - more detail • Applications formally screened upon receipt • Target screening time 20 working days (C1 = 5 WD) • One opportunity for applicant to remedy ‘minor oversights’ - these to be corrected within 5 working days • On completion of screening, formal letter of acceptance or otherwise Result: • Only ‘good’ applications are evaluated • Wastage of evaluation time is minimised • Processing of ‘good’ applications is quicker and more predictable


Presenter

Presentation Notes

Screening is a critical element of achieving predictable processing times. With the best willing the world, each application is unique and requires a different level of input to process. Screening helps us to identify that in the beginning and plan accordingly. Also it helps ensure that defective applications to not enter the evaluation stream and clog it up for good quality applications.

Progress so far? Further opportunities? • Efficient and cost-effective evaluation processes, operating within an appropriate benefit/risk model? • Greater transparency and predictability of the regulatory • Process? • Improve the quality of OTC medicine applications lodged?


Presenter

Presentation Notes

So this is a recap of what we are aiming for How far have we progressed in achieving it? And what are our main remaining opportunities for improvement? This is the subject of the following slides

First stage targets (2012 consultation paper)


New Product Applications Preparation

and Lodgement

Preparation and

Lodgement

Preparation and

Lodgement

Preparation and

Lodgement

Preparation and

Lodgement

Evaluation1

Evaluation1

Evaluation1

Evaluation1

Evaluation1

Screening

Screening

Screening

Screening

Screening Finalisation

150 days

75 days

45

days

170 days

38 %*

15 %*

30 %*

15 %*

Decision Finalisation 210 days 2%

Decision

Leve

l 1

Leve

l 2

Leve

l 5

Leve

l 4

Leve

l 3

Changes to previously approved OTC Medicines Preparation

and Lodgement

Preparation and

Lodgement

Preparation and

Lodgement

Preparation and

Lodgement

Decision

Evaluation1

Evaluation1

Evaluation1

Evaluation1

Screening

Screening

Screening

Finalisation

Finalisation

64 days

170 days

20 days

120 days

70 % *

25% *

4% *

1% *

Decision

Leve

l C1

Leve

l C2

Leve

l C3

Leve

l C4

All target times are expressed in working days, and refer to the time taken for evaluation and decision by the TGA only

Presenter

Presentation Notes

These show the target times that the TGA committed to in the consultation paper in September 2012. They cover the process from the time the application is accepted for evaluation, to the time that a decision is communicated to the applicant. As said earlier, with the guidelines that clarified in advance where any given application would fit in the overall framework, sponsors now have a first estimate of how soon their application should be processed. Along with these target times, ‘aspirational’ target times for mid 2016 were posted. These present a considerable decrease in target times. Whether we will be able to achieve these remains to be seen.

Last half year results - evaluation times*


*Acceptance of application to Delegate’s decision

Elapsed working days

Application type Number evaluated

Range Average Median

Target time (WD)

%within target time (KPI=80%) Minimum Maximum

N1 - clone 136 1 114 21 7 45 98

N2 - monograph 2 49 49 49 49 75 100

N3 39 33 147 97 91 150 100

N4 17 78 133 105 104 170 100

N5 3 na na na na 210 na

C1 – notifications 194 1 130 16 11 20 84

C2 170 1 129 40 33 64 98

C3 6 9 122 33 9 120 100

C4 3 69 69 69 69 170 100

Total 570

Presenter

Presentation Notes

This slide shows the results for the 6 months to (Dec 2013? June 2014? Need to check) What is shows is that on average the processing times are well within the target. In April this year we reduced the target for C2 applications from 75 working days to 64. As time and further performance history emerges, prudent reductions in other target times will be considered. Our focus at present is to reduce the distance between the maximum and minimum times, but this is not a practical objective until we have made further progress in bedding down internal IT systems for managing work flow. We are devoting considerable time to this aspect.

Results of evaluations - last half year


Result

Application category Returned Withdrawn Rejected Approved Total

N1 – clone 0 5 0 131 136

N2 – monograph 0 0 0 2 2

N3 6 1 0 38 45

N4 6 0 1 17 24

N5 2 2 0 1 5

Average % 7% 4% 0% 89% 100%

C1 – notifications 0 10 0 184 194

C2 0 1 0 169 170

C3 0 0 0 6 6

C4 0 0 0 3 3

Average % 0% 3% 0% 97% 100%

Total 14 19 1 551 585

Presenter

Presentation Notes

This slide shows the results of completed applications for the last half year. As you can see most were approved. What is not shown is the number of applications where the TGA had to ask the applicant to address minor defects at screening stage. These are far higher than the number returned as not acceptable for evaluation.

Results so far - efficiency, timeliness, visibility • Eradication of backlog over 18 month period, of approximately 500 applications that was present at the

beginning of the OTC reforms • Weighted average processing times for new medicine applications have reduced from approximately 131

working days to approximately 76 working days* • Weighted average processing times for variation applications have reduced from approximately 64 working

days to approximately 33 working days* • Upgrade to online application system

– eradicates need for applications on paper (reducing dossier creation, transport, processing and storage costs in industry and the TGA)

– provides enhanced online tracking of progress for each application for the applicant

*(baseline, calendar 2011)


Presenter

Presentation Notes

In early 2012 we had over 500 application on hand, some of which had been in the system for years. I hasten to add, not solely due to the TGA. By early this year these ‘old’ application had been reduced to 2, while continuing to reduce the average processing time for incoming applications. As of last week we have under 200 applications in process, of which 5 are in danger of exceeding the target time. This does not mean we are satisfied, but it is a considerable improvement. The upgrade to the on line application entry system commenced operation in April this year. Generally it has been a great benefit internally, and has had good comment from industry.

Remaining opportunities - TGA systems • Upgraded IT systems are still in their infancy • Fix elements of the industry interface that are still causing problems • Refine the internal system to streamline work practices further

– (this is likely to be ongoing ‘continuous improvement’)


Presenter

Presentation Notes

But the application portal has only been in place since April. Key concerns at present involve the initial and final validation and write process, and some elements of composite packs and Multichange applications. (Mayada, some further detail follows. I would avoid going to tis level if possible – just say you are aware but have specialists who are responsible for the details. Initial write: strange and often irrelevant warning messages. Final write: sponsor verification, final validation by TGA. Composite packs particularly multi dosage forms: container and shelf life details, manufacture details, for each dosage form. Multichange applications: system allows some applications in Multichange that are not in reality available). We are also paying considerable attention to improving internal work flow management systems make individual accountability for target times more visible, and to provide daily updates of status on every application to management on an exception basis. (Mayada I am talking about the systems that will replace the spreadsheets: evaluator interface, supervisor summary)

Remaining opportunities - evaluation process • Reduce variation in processing times to improve predictability

– introduction of workflow management – internal target times for each step in the evaluation phase – reorganise the internal handling of Clone applications

• Review total evaluation process target times – already done in April this year for C2 category – need further bedding down of internal IT systems before extending to other categories

• Introduce a target time for the initial evaluation phase – already introduced in April this year for C2 category – next candidates: N3, N4, N5 categories


Presenter

Presentation Notes

Provided we can successfully implement these internal management IT platforms, we expect to see the improvements shown in this slide. We are experiencing a major increase in N1 (clone) applications, and coming at the same time as retirement of an experienced person , it is creating a challenge for us that we expect to be short term.

Remaining opportunities - streamline • Create additional monographs • Extend use of monographs, e.g.

– a monograph based N4 application with an umbrella segment • Looking to Health Canada for further ideas in adoption of the monograph concept


Remaining opportunities - industry Be well versed in the guidelines before making a submission! • Comprehensive covering letter summarising all key points • LB submissions - fully consistent with the guideline (ARGOM Appendix 1) • Check - is there a need for equivalence data? • Stability studies: design, data, test methods

– eg. PET, minimum data requirements, etc. • Product Information document (PI) is in the required format


Comprehensive covering letter - some points New registration applications • Product description, application level and why • Relationship with other products of Sponsor (e.g. line extension) • If a generic, nominate the originator product or a generically similar product Change applications • Describe nature and scope, and reason for wanting the change

– (do not simply rely on the change code) • If changes are complex/numerous, provide a changes table

– eg. current details, proposed details, reasons, comments, assurances, etc.


Other aspects - some realities for industry C2 applications • More C2’s evaluated (year to June 30) than other application types • Individual C2 applications vary from extremely simple to quite complex • Hence working days for evaluation, and queue times, may vary considerably • So - target times will be met, but otherwise, total flexibility is needed Declarable excipients database • Never intended, nor possible, for it to be totally comprehensive • So (continuous improvement):

– if an ingredient is not on the database, please let us know – we will organise for it to be incorporated for the future

• Accessible documentation – no built in security that inhibits TGA access


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