Risk management plans for medicines and biologicals

12 December 2017

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Submitting RMP updates after regulatory approval

The updated RMP or PSUR are not replacements for normal mechanisms of informing us about safety-related issues.

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.

There is no requirement to send the clinical delegate a copy of updated RMPs.

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

AND

  • 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.

Other requirements

  • 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

Contact information

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
Australia
Phone: 02 6232 8841
Email:   rmp.coordinator@health.gov.au

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