Information on post-market RMP/ASA updates

1. Post-market RMP/ASA updates
Vicky Dong
RMP Evaluation Section
Post-market Surveillance Branch
March 2015

2. Guidelines
• EU Guideline on good pharmacovigilance practices Module V – Risk
management systems (Rev 1) (15 April 2014)
• Risk management plan (RMP) questions & answers (March 2015)
1Post-market RMP/ASA updates

3. Do submit an updated RMP for the following:
• Request made by the TGA
• Significant changes to the RMP, eg:
– New information that may lead to a change to the risk/benefit profile
– Changes to safety concerns
– Pharmacovigilance and/or risk minimisation activities added,
terminated, or substantially altered
(RMP Q & A, March 2015)
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4. Don’t submit an updated RMP for the following:
• Routine document updates (EU guideline)
• Updates unrelated to product’s safety profile
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5. What should an updated RMP look like?
• A complete document
• In required format for EU-RMP, ASA
• Changes from the previous version in a summary table
• Accompanied by a cover letter: who, what, why
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6. You’ve submitted the update, then what?
• TGA will acknowledge receipt
• Review will be conducted
• You will be contacted if:
– questions remain
– Issues need discussion
(RMP Q & A)
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7. If you are uncertain…
• Email: rmp.coordinator@tga.gov.au
• Phone: 02 6232 8841
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8. 7Presentation title
• Significant changes to the RMP, eg:
– New information that may lead to a
change to the risk/benefit profile
– Changes to safety concerns
– Activities added, terminated, or
substantially altered

9. Example A:
• My company received 3 reports of liver function abnormality related to
product A last year. All patients’ liver function returned to normal within 4
weeks without stopping the treatment. There were multiple confounding
factors to establish causality in all 3 cases. ‘Effects on liver function’ is
listed as missing information in the RMP and in the PI for product A. No
change to the PI is planned because no causal relationship could be
established. Do I need to submit an updated RMP for product A?
Post-market RMP/ASA updates 8

10. Example B:
• We have recently completed a clinical study listed as an additional
pharmacovigilance activity to monitor the risk of ‘systemic infection’ for
product B. The study showed that patients taking product B did not have a
higher incidence of systemic infection compared to placebo. We have
included the study report and a summary of findings in the latest PSUR.
We plan to update the RMP and remove ‘systemic infection’ from the
safety concerns list. Do I need to submit the updated RMP?
9Post-market RMP/ASA updates

11. Example C:
• ‘Use in patients above 65 years of age’ has been listed in the RMP as
missing information for product C. Last month, we received the final study
report for a cohort study conducted on patients taking product C. This
study was listed as a pharmacovigilance activity in the RMP. The study
results showed that patients above 65 years of age did not have a higher
incidence of adverse events compared to younger patients. We plan to
remove the study from the RMP. Do I need to submit an updated RMP?
Post-market RMP/ASA updates 10

12. Example D:
• Our product D has been approved for weight control in obese adults.
‘Lower seizure threshold’ has been listed as an identified risk in the RMP. In
the last 6 months, we received 12 reports of seizure related to product D.
This was more frequent than what we expected. We plan to send a ‘Dear
Healthcare Professional Letter’ to provide warning against this risk. Do I
need to submit an updated RMP for product D?
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13. Example E:
• Over the last 12 months, we delivered the physician educational material
with a physician survey for product E as outlined in the RMP. In return,
we only received survey responses from 2% of the physicians. We plan
to stop the supply of the educational material and update the RMP to
remove the educational activity. Do I need to submit an updated RMP to
the TGA?
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