The document provides an update on recent activities of the Therapeutic Goods Administration's Scientific Evaluation Branch. It discusses the launch of an electronic form for prescription medicine variations and notifications, as well as a comparable overseas regulator report-based process. It also covers work-sharing with international regulators, biological and biosimilar naming conventions, and reforms to the regulation of autologous human cells and tissues. Recent approval times for different drug categories are presented, along with the impact of stopping the approval clock in some cases. Efforts for continual improvement in evaluating generic medicines are also noted.

1. Update on recent TGA activities
Scientific Evaluation Branch
Rochelle Christian, Assistant Secretary, Scientific Evaluation Branch
Therapeutic Goods Administration
ARCS Regulatory Affairs Interest Area Meeting
27 March 2018

2. Presentation overview
Variations e-form and notifications
Comparable Overseas Regulator (COR) reports and work-sharing
Biological and biosimilar medicines naming
Autologous human cells and tissues
Continual improvement – generic medicines
Prescription medicines reforms update 1

3. Prescription Medicines Variations e-Form
• Launched in mid-2017
• Since then > 2,000 submissions
• Changes to manufacturing information –current clearances needed for
all nominated manufacturers
• Modified December 2017
 New change codes and descriptions added
 Allow attachment of supporting data
 Updated print preview
 Introduction of notifications 2

4. Variations to prescription medicines
• Phase 1: Notifications for low risk changes to prescription medicines
– Launched 4 December 2017
– Must be submitted using the e-form
– c. 330 notifications submitted, affecting over 1,000 ARTG entries
• Phase 2: Investigating further risk-based approach to variations
Prescription medicines reforms update 3

5. Comparable Overseas Regulator (COR) report-based process
From 2 January 2018
• For prescription medicines with full marketing approval from a
COR following a de novo evaluation.
• Six overseas regulators identified as CORs.
• Unredacted COR evaluation reports must be provided by the
applicant.
• Two approaches*:
– COR-A 120 working days
– COR-B 175 working days
*depending on extent of TGA evaluation required. 4

6. Work-Sharing
• Simultaneous evaluation between multiple CORs
– Current work with ACSS partners
– Joint evaluation report
– Independent decision-making
– Creation of template documents, alignment between agencies
– Early stages of development
Prescription medicines reforms update 5

7. Biological and biosimilar medicines naming
• Consultation in 2017
– Improve collection of adverse events information
• Government’s decision
– maintain existing convention i.e. continue using the Australian biological name (without
a suffix)
– mandatory reporting of the product's trade name, as well as the non-proprietary name,
when reporting an adverse event to TGA
Prescription medicines reforms update 6

8. Autologous human cells and tissues
• Historically seen as medical practice and outside TGA’s regulatory oversight.
• Growing global concern with direct to consumer advertising of unproven autologous
stem cell interventions.
• Consultation on reforms to regulation in 2015 & 2016
• October 2017 government decision announced
• Level of regulation (as biologicals) determined by the risk posed to patient safety
• Drafting regulatory guidance & amendments to regulations
Prescription medicines reforms update 7

9. Context
Government:
• MMDR reforms – new
pathways, shorter timeframes
• PBS expenditure – more
expensive drugs for smaller
populations
• Affordable & sustainable
health system, especially PBS
• Patient expectations for early
access to cheaper medicines
• Recruitment controls
Sponsors’ feedback:
• Generics take almost as
long as NCEs
• Milestones important for
predictability
• Appreciate cooperative
approach to get products
over the line
• Focus on material
aspects
Industry 4.0:
• Changing profile of
new medicines –
more complex
generics but fewer
overall
• Increase in NCEs &
biosimilars & shift to
immunotherapeutics
& personalised
medicines
8

10. Recent approval times
Category 1 (255 working days)
Jul-Dec 2017 Jan–Jun 2017 Jul-Dec 2016
Application Type Approved Mean Approval
Time
Range Approved Mean Approval
Time
Range Approved Mean Approval
Time
Range
New Chemical Entity 22 209 152-245 14 209 177-232 23 200 161-238
Fixed-dose
Combination
1 178 178 0 N/A N/A 4 204 179-218
Extension of
Indications
21 183 85-223 23 197 106-235 20 199 147-238
Generic medicine 55 190 123-254 59 186 109-254 53 177 124-253
Major Variation 21 195 155-254 22 181 139-226 24 195 134-224
PI Change 41 130 7-242 35 143 46-228 30 142 65-212
9

11. Approval times - Impact of stop clocks
10

12. Continual Improvement – generic medicines
• Discussions with GBMA and other industry representatives :
– Dossier quality
 Common issues
 Options to address
– Options for accelerated review of some generic medicines
11

13. QUESTIONS?
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