Risk management plans for medicines and biologicals

12 December 2017

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Frequently asked questions

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Yes.

Once each safety issue has been appropriately identified and characterised, the sponsor must propose a plan on how they will manage this risk. In some cases, the sponsor may propose that routine product vigilance will be sufficient.

Yes.

Once each safety issue has been appropriately identified and characterised, the sponsor must propose a plan on how they will manage this risk.

In some cases, the sponsor may propose that routine risk minimisation is sufficient, as defined in

  • EMA/204715 Guideline on good pharmacovigilance practices - Module XVI– Risk minimisation measures: selection of tools and effectiveness indicators

No.

Sponsors are required to comply with the requirements set out in:

Any interventions or activities proposed in the RMP may be additional to routine pharmacovigilance or biovigilance.

The sponsor is responsible for monitoring and evaluating the effectiveness of additional risk minimisation activities.

The proposed activities should be dependent on an assessment of the risk, the population, and how the risk changes during the course of the post‐market period.

Guidance on the measurement of additional risk minimisation activities is in:

  • EMA/204715 Guideline on good pharmacovigilance practices - Module XVI– Risk minimisation measures: selection of tools and effectiveness indicators

Submit both an EU RMP and ASA.

If no EU RMP exists, submit an alternative RMP covering all modules in the EU RMP, preferably in the EU format. (See RMP format)

If you have a TGA‐approved RMP, you should maintain and update it (in accordance with relevant guidance) regardless of its marketing status.

The sponsor is responsible for ensuring compliance with RMP commitments, and should notify us as soon as possible if (for whatever reason) RMP commitments are unable to be met as stated.

Once an RMP has been evaluated, we will undertake periodic audits and monitoring to assess whether post‐marketing commitments contained in the RMP are met.

The AusPAR contains a section on Pharmacovigilance findings, which may include the following information:

  • Safety specification – a summary of the safety concerns and evaluation of the pharmacovigilance and risk minimisation activities described in the RMP. If additional risk minimisation activities are required, these will be included.
  • We will supplement this information with a table containing the proposed pharmacovigilance activities and proposed risk minimisation activities for each identified safety concern.
  • The AusPAR may include timelines for planned activities, such as reporting dates for planned studies, communication program milestones, any differences between the risk minimisation activities undertaken in Australia compared to the EU.
  • RMP Evaluation – important issues raised in the RMP Evaluation Report and the RMP Advice document.
AusPARs are not currently published for biologicals.

Conditions of registration or inclusion:

  • will include the latest reviewed version of the RMP and ASA (taking into account any updates provided during the evaluation process)
  • may include the sponsor's written agreements to the RMP evaluator's recommendations during the s31 process or s32JA process (those not explicitly stated in the RMP document)
  • will include any further requirements determined by the Delegate

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