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Risk Management Plans: Advice from the TGA

Members of our Drug Safety team were very interested to hear from the TGA at the 2015 ARCS Scientific Congress on the issue of Risk Minimisation Plans.

Risk Management Plans (RMPs) are deemed necessary given that clinical trials generally cannot highlight all the safety issues related to a medicine. RMPs for medicines include risk minimisation activities to inform and educate patients and healthcare professionals, and to help prevent or mitigate adverse effects.

An RMP is always required for:

  • A new chemical/biological entity
  • Higher risk (Class 3 and 4) biologicals
  • Biosimilars
  • Vaccines
  • An RMP is usually required (but may need case-by-case consideration) where there is:

  • A change to indication which includes the following: significantly different population, paediatric patients, significant change in prescriber profile, identification of a new safety concern.
  • A new route of administration, dosage form or strength has an inherently higher risk eg oral tablets vs IV injection.
  • A significant safety issue with one or both active ingredients in combination products.
  • A generic medicine/s where the innovator product has additional risk-minimisation activities.
  • The TGA’s top RMP Tips from Dr Jane Cook, Branch Head, Post-market Surveillance Branch, Monitoring and Compliance Division, TGA, were:

    1. Provide the EU RMP (if there is one) and an Australian Specific Annex (ASA)
    2. Make sure all the info asked for in the ASA template is provided
    3. Provide all documents referred to in the RMP and ASA
    4. Address all RMP evaluator recommendations
    5. Whenever there is an update, state clearly what has changed and why
    6. Ask if uncertain via: [email protected]

    It was noted that the population of Australia can be considered different to other regions due to our indigenous population, large Asian population, rurality/lack of access to specialist services and state vs federal control over health matters.

    For help with your RMP requirements, call us on +61 3 9251 0777.

    This article was written by Tina Mason from our Drug Safety team.

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