Risk management plans for medicines and biologicals
Submitting RMP updates after regulatory approval
Whenever you submit an updated RMP, ensure you:
- clearly indicate all changes from previous RMPs in the documents (preferably in a summary table)
- include a cover letter stating the reason for submission
This will allow for a more efficient evaluation of the updated RMP.
Ensure you maintain records of when RMPs were submitted to the TGA and the significant changes between each version of the RMP.
When to submit an updated RMP
Submit an updated RMP:
- when we request it
- whenever there is a significant (material) change to the RMP, including but not limited to:
- when the RMP is modified as a result of new information that may lead to a change to the benefit-risk profile
- when an important (product vigilance or risk minimisation) milestone is reached, or an activity is terminated, added, or substantially altered
- when changes to the summary of ongoing safety concerns are made
In addition, we may require an updated RMP after registration to incorporate the changes agreed prior to approval.
If the date for the submission of a Periodic Safety Update Report (PSUR) and the need to update an RMP coincide, both can be submitted at the same time.
If you are uncertain whether an updated RMP should be submitted
Contact the RMP coordinator for advice.
What to include with an updated RMP
Ensure you include:
- an updated ASA with any updated EU RMP submitted
- a summary of all changes since the previous version
If no change or update to the ASA is required, identify this at the start of the ASA by including a statement that all Australian specific information is unchanged.
Where RMPs are not required
Where RMPs are not required, but voluntarily submitted by sponsors (that is, no RMP evaluated in Australia for that product), ensure you summarise the reasons for:
- an updated RMP being required in the EU
- the change (if any) in the safety information
Periodic Safety Update Reports (PSUR)
The TGA has adopted the EU PSUR guidelines with annotations:
- EMA/816292 Guideline on good pharmacovigilance practices (GVP) Module VII - Periodic safety update report
Where we have identified additional safety concerns and these have been included in the ASA, ensure you report these in an attachment to the PSUR.
- An RMP update or PSUR does not necessarily require a minor variation request or notification. However, other regulatory processes may need to occur, such as a safety-related request (a type of minor variation).
- For Product Information (PI), Consumer Medicine Information (CMI) or Patient Information Leaflet changes with no impact on the RMP, include a sentence in the updated document package for the PI or CMI change justifying why an RMP change is not required.
Acknowledgement, evaluation and feedback of the updated RMP
Where updated RMPs are required, we will:
- acknowledge receipt
- conduct the review
- contact the sponsor if there is a query or an issue that needs to be discussed
Please direct any questions and advice relating to Risk Management Plans (RMPs) to:
Post: RMP Coordinator
Pharmacovigilance and Special Access Branch
PO Box 100 Woden ACT 2606
Phone: 02 6232 8841