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Risk management plans for medicines and biologicals

Australian requirements and recommendations

29 March 2019

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Monitoring compliance with RMP commitments

You are responsible for:

  • maintaining the currency of your RMP,
  • implementing the risk management activities included in it,
  • collecting and analysing information generated by risk management activities to inform adjustment of your risk management system, and
  • notifying the TGA of important changes to your RMP

We will undertake periodic desktop audits of documents you have submitted to us to ensure that you are undertaking or have completed risk management activities in accordance with your RMP. In addition, if you are selected for a pharmacovigilance inspection you may be required to provide evidence to demonstrate your compliance with RMP commitments.

We may contact you if reporting dates for risk management activities are due and we have not received information from you. For example, we may check that:

  • additional risk minimisation interventions have been implemented and their effectiveness has been assessed, and any required evaluation reports submitted to us
  • you have submitted the study reports of additional pharmacovigilance activities for which submission is required (as described in your ASA or conditions of registration)

You should ensure that your RMP clearly describes the timeframes for completing risk management and pharmacovigilance activities, and how and when the outcomes will be reported to the TGA. You may need to submit an updated RMP to us at the completion of the evaluation process to reflect any changes required during the round 2 evaluation.

If you are unable to meet a commitment described in your RMP, you should notify us as soon as possible, and provide us with a proposal for amendments to your RMP, with a justification (see Submitting RMP updates after regulatory approval).

Compliance and enforcement

The Regulatory Compliance Framework sets out the TGA's overall approach to compliance.

If we identify that you have not undertaken your risk management commitments in accordance with your RMP we will generally, in the first instance, work with you to address the deficiencies.

If we identify significant non-compliance with your risk management commitments we can:

  • cancel or suspend medicines from the ARTG for refusing or failing to comply with a condition of registration or listing, under subsections 29D(1)(b) and 30(2)(c) of the Act
  • prosecute offences related to not complying with conditions of registration or listing, under Section 21A of the Act

We publish information about regulatory compliance decisions and actions, such as compliance undertakings, cancellations and suspensions, on our website.

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