The document summarizes the key changes to the 2019 Risk Management Plan (RMP) guidance from the Australian Therapeutic Goods Administration (TGA). It outlines expanded guidance on when to submit an RMP, requirements for generics, and updating RMPs. It also describes changes to the Australia-specific Annex (ASA), including new sections to describe differences from the EU on safety concerns, activities, and risk minimization in Australia. The ASA is intended to document the Australian risk management system and commitments to the TGA.

1. What’s new in the 2019 RMP guidance update?
Elspeth Kay, Director
Risk Management Plan Evaluation Section
Pharmacovigilance and Special Access Branch
Australian Pharmacovigilance Regulatory Requirements and Risk Management Plans Summit
27 March 2019

2. • What’s new in the RMP guidance
• What to include in your Australia-specific annex?
What’s new in the 2019 RMP guidance update? 1

3. • Aims:
– to clarify and provide greater detail on existing requirements for RMPs, PSURs and monitoring of
compliance with RMP commitments
– to describe proposed changes to submission and evaluation of RMP updates
– update template for ASA
• Requirements are essentially unchanged
What’s new in the 2019 RMP guidance update? 2

4. Guidance changes
Expanded and clarified guidance on:
• when to submit an RMP with an application
• RMP requirements for generics
• when to submit an updated RMP
New guidance on:
• how to submit an updated RMP, with a new form to describe changes
• submitting risk minimisation materials for review
• how we determine PSUR conditions of registration
• how we monitor compliance with RMP commitments
3What’s new in the 2019 RMP guidance update?

5. ASA changes
Removed:
– registration history, list of concurrent applications,
comparisons of EU and Australian indications
– requirement to include discussion of epidemiology
for generics and biosimilars
– pharmacovigilance organisation in Australia
section
– request to append follow-up forms if already
attached to EU RMP
– comparison of PI/CMI and SmPC/PL wording
Added:
- sections aligned with EU RMP format
- prompts to describe differences between Australia and the
EU in safety concerns, pharmacovigilance activities and risk
minimisation activities
- sections to propose changes to Australia-only safety
concerns and risk minimisation
- tables to record:
- requirements to submit reports from pharmacovigilance
activities, if any
- details of implementation and evaluation of risk
minimisation in Australia
The ASA describes differences between Australia and the EU in the risk management system, documents reporting
commitments to the TGA, and records details of implementation and evaluation of risk minimisation in Australia.
What’s new in the 2019 RMP guidance update? 4

6. Section 1 – Product overview
• History of RMPs submitted in Australia
– Describe differences between versions (may refer to Annex 8 of the EU RMP)
What’s new in the 2019 RMP guidance update? 5

7. Section 2 – Safety specification
• Epidemiology of the indication(s) and target population(s)
– Brief summary of Australian epidemiology, considering whether there are any notable differences from the
EU
– Provide information on the use of the product in Australia that may be relevant to the risk management
system, such as:
 setting of use? (hospital, home, treatment centre)
 who is involved?
 access to tests or other technologies?
 considerations for specific groups
• Generics and biosimilars
– No need for epi summary BUT consider any risk management issues that may arise from introduction of
the product
What’s new in the 2019 RMP guidance update? 6

8. Section 2 – Safety specification
• Summary of the safety concerns
– Are you proposing any differences from the summary of the safety concerns in the EU RMP? Why?
– Do you propose any Australian safety concerns, or has TGA required them?
 If yes, describe
– Section to propose removal of Australian safety concerns
What’s new in the 2019 RMP guidance update? 7

9. Section 3 – Pharmacovigilance plan
• Routine pharmacovigilance
– Summary of activities beyond adverse reaction reporting and signal detection
– Attach forms to the ASA if not attached to the EU RMP
– Describe how you’ll seek Aboriginal and/or Torres Strait Islander origin, if not on form
• Additional pharmacovigilance
– State any differences from plan for the EU
– Provide a summary of any Australian activity and attach protocol to ASA
• Summary table
– Overview of all additional activities
– Space to record whether submission to the TGA is required
What’s new in the 2019 RMP guidance update? 8

10. Section 4 – Clinical study plan for provisional registration
• Only for applications in provisional pathway
• Refer to guidance on provisional registration process
What’s new in the 2019 RMP guidance update? 9

11. Section 5 – Risk minimisation plan
• Routine risk minimisation
– Sections of PI and CMI for each safety concern
– Any other routine risk min for each safety concern
– Is the CMI in the pack? Is there a patient alert card or IFU in the pack?
• Additional risk minimisation
– State whether there are any differences from EU RMP or the innovator (if generic)
– Space to propose removal of an activity (may refer to information in the EU RMP)
– Describe Australia-only additional risk minimisation activities
What’s new in the 2019 RMP guidance update? 10

12. How additional risk min will be implemented
• Summarise
– what will be implemented
– for whom
– how
– when
Additional risk minimisation
activity
Target audience Implementation details, including method(s) of dissemination Time-points for and frequency of dissemination
e.g. health professional guide and
checklist
GPs
pharmacists
Paper copies posted to GPs and pharmacists on sponsor-held mailing
list
At launch
Mailing list reviewed every 6 months and brochure mailed
to new additions
Repeat mail at 18 months after launch
e.g. patient guide patients Paper copies posted to GPs to provide to patients (initial mailing of 5
copies); GPs can re-order through sales reps and Medical Information
Electronic copies available through patient support program website
At launch
Mailing list reviewed every 6 months and brochure mailed
to new additions
Repeat mail at 18 months after launch
What’s new in the 2019 RMP guidance update? 11

13. How additional risk min will be evaluated
• How will each activity be evaluated?
• How and when will evaluation results be reported to TGA?
Additional risk minimisation
activity
Evaluation plan and criteria for success Submission of results to TGA: deliverable and
timeframe
eg Health professional guide and
checklist
Initial and 2nd distribution completed to at least 90% of target audience
EU survey of GP and pharmacist knowledge, criteria as per protocol in EU
RMP
Australian drug utilisation study using GP prescribing data (see attached
protocol)
Evaluation report (incl PASS results, DUS outcomes and
distribution information) to be submitted to TGA by 24
months after first supply
eg Patient guide Guide tested with consumers prior to finalisation and distribution
Initial and 2nd distribution to GPs completed
Final materials provided for TGA review with results of
testing, prior to distribution
Distribution information to be included in evaluation
report to be submitted to TGA by 24 months after first
supply
What’s new in the 2019 RMP guidance update? 12

14. Section 6 – Summary of the RMP in Australia
Important Risks and Missing
Information
Safety concern
Routine
pharmacovigilance
activities
Additional
Pharmacovigilance
Activities
Routine risk
minimisation
activities
Additional Risk
Minimisation
Activities
Important
identified risks
Hepatotoxicity Targeted follow-up None Yes HCP education
…
Important
potential risks
Medication error Targeted follow-up EU patient registry Yes Dosing card;
Patient alert card
QT prolongation Clinical Trial ####
(includes Australian
patients)
None
…
Missing
information
Use in pregnancy EU patient registry Yes None
Use in children None Yes None
…
What’s new in the 2019 RMP guidance update? 13

15. Section 7 - Annexes
• Attach relevant documents that are not already attached to the EU RMP, such as
– Follow-up forms (Annex 1)
– Study protocols (Annex 2)
– Additional risk min materials (Annex 3)
What’s new in the 2019 RMP guidance update? 14

16. Summary
• The updated RMP guidance contains more information about
– when an RMP is required
– when and how to submit an updated RMP
• If in doubt, contact the RMP coordinator rmp.coordinator@health.gov.au
• The ASA
– describes the risk management system for Australia with reference to the EU RMP
– documents reporting commitments to the TGA
– records details of implementation and evaluation of risk minimisation in Australia
What’s new in the 2019 RMP guidance update? 15