Post-market RMP/ASA updates Vicky Dong RMP Evaluation Section Post-market Surveillance Branch March 2015
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) Post-market RMP/ASA updates 1
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) Post-market RMP/ASA updates 2
Don’t submit an updated RMP for the following: • Routine document updates (EU guideline) • Updates unrelated to product’s safety profile Post-market RMP/ASA updates 3
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 Post-market RMP/ASA updates 4
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) Post-market RMP/ASA updates 5
If you are uncertain… • Email: rmp.coordinator@tga.gov.au • Phone: 02 6232 8841 Post-market RMP/ASA updates 6
• 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 Presentation title 7
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
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? Post-market RMP/ASA updates 9
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
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? Post-market RMP/ASA updates 11
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? Post-market RMP/ASA updates 12
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