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Risk management plans for medicines and biologicals

Australian requirements and recommendations

29 March 2019

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Submitting RMP updates after regulatory approval

The updated RMP is not a replacement for normal mechanisms for informing us about safety-related issues.

Whenever you submit an updated RMP, ensure you:

  • use the form provided to describe why you are submitting the RMP, and provide the form in Module 1.0.1. and
  • clearly indicate all changes from previous RMPs in the documents (preferably in a summary table, which may be in Annex 8 of the EU-RMP and section 1.2 of the ASA)

When to submit an updated RMP

You must submit an updated RMP and/or ASA when we request it and whenever there is significant change, such as:

  • when the summary of safety concerns changes, including when the EMA has approved removal or reclassification of safety concerns
  • when an additional product vigilance or risk minimisation activity is ceased, added, or substantially altered for example,
    • if the objectives, patient population or expected completion date of an additional pharmacovigilance activity change or if the pharmacovigilance activity is ceased early
    • if a new additional pharmacovigilance activity is added
    • if you propose to cease an additional risk minimisation activity, add or remove a safety concern from risk minimisation activities, or implement a new additional risk minimisation activity
  • for provisionally registered products, if there are any changes to the objectives, population or due date of final results for any of the studies listed in the clinical study plan

You do not need to submit an updated RMP on expected completion of a pharmacovigilance activity that appears in the EU RMP if there are no changes to the summary of safety concerns or risk minimisation plan as a result. You should, however, submit an updated ASA +/- RMP on completion of any additional pharmacovigilance activities that have been implemented at the request of the TGA (which are likely to appear only in the ASA).

We may require an updated RMP to incorporate changes that have already been agreed such as through the evaluation process for registration of a new product, extension of indication or variation, or safety-related request.

Submitting an updated RMP is not a substitute for other regulatory requirements, such as submitting minor variations or safety-related requests, or notifying the TGA of significant safety issues.

You should update your risk management plan when new information becomes available regardless of whether your product is marketed. You should ensure that you always keep your RMP and ASA up to date for your own records and because we may request an updated RMP from you at any time.

Timeframes for submitting updated RMPs

You should seek agreement from the TGA before prematurely ceasing or significantly altering:

  • additional risk minimisation that is being undertaken in Australia
  • additional pharmacovigilance that is being undertaken in Australia at the request of the TGA

If you are proposing changes to the risk management system in response to a significant safety issue, you should advise the TGA of the significant safety issue within 72 hours, as per the Pharmacovigilance responsibilities of medicine sponsors. You can submit the updated RMP after the response to the safety issue has been agreed with the TGA.

For changes that have been accepted by the EMA and do not affect additional risk minimisation activities being undertaken in Australia or additional pharmacovigilance activities being undertaken in Australia at the request of the TGA, then we recommended that the updated RMP/ASA is submitted within 3 months of the change being accepted by the EMA. If updates to the RMP coincide with an extension of indication or variation for which submission of an RMP is a requirement, then it is acceptable to submit the updated RMP only in support of the application.

What to include with an updated RMP

Please include:

  • the completed 'submission of an updated RMP' form in module 1.0.1 describing the reasons for submitting the RMP update,
  • an updated ASA with any updated EU RMP submitted, or a statement on the 'submission of an updated RMP' form that the changes to the EU RMP do not warrant any changes to the ASA, and
  • a summary of all changes since the previous version (in the EU RMP and/or the ASA).

If only the ASA has been updated, then it is not necessary to resubmit the EU RMP if you have previously provided the EU RMP to the TGA. Ensure you maintain records of when RMPs were submitted to the TGA and the significant changes between each version of the RMP.

How to submit an updated RMP

Each updated RMP and ASA that you submit to the TGA should be submitted as an eCTD/NeeS sequence. The RMP and/or ASA should be in module 1.8.2. An updated RMP not submitted as part of another regulatory activity should be submitted as a standalone sequence with sequence type 'risk management plan'.

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 wish to seek advice from the TGA on the acceptability of proposed changes to the EU RMP and/or ASA before submitting as a sequence, please email your request for advice to the RMP coordinator, describing the proposed changes using the 'Submission of an updated RMP' form, and providing relevant details of and a justification for the changes. If possible, include the draft updated EU RMP/ASA.

An RMP update does not require a minor variation request or notification.

Evaluation of the updated RMP

We will acknowledge receipt of the updated RMP and evaluate the changes. We will contact you to advise acceptance of the changes or request further information. We will not usually give you an evaluation report.

Submitting risk minimisation materials for review

If you are submitting draft risk minimisation materials for review after regulatory approval and there are no changes to the RMP and/or ASA then you do not need to submit an updated RMP and Submission of an updated RMP form. In these cases you should send the materials to the RMP coordinator (RMP.coordinator@health.gov.au) with a covering email providing background to the request for review and your anticipated timeframe for finalising and disseminating the materials.

If we have not previously reviewed drafts of your materials then we recommend that you allow 6 weeks for review and approval to allow for the possibility of multiple rounds of revisions.

If you require rapid review of materials, please contact the RMP coordinator as early as possible prior to submitting the materials so that we can determine a suitable timeframe for submission and assessment.

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