Risk management plans for medicines and biologicals

12 December 2017

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RMP format

Risk management plans should comply with all of the following:

  • EMA/838713/2011 Guideline on good pharmacovigilance practices (GVP) Module V — Risk management systems (with the exception of section V.C.3.1‐Requirements in specific situations)
  • EMA/PRAC/613102 Guidance on the format of the risk management plan (RMP) in the EU — in integrated format

Include an Australian-specific Annex (ASA) to document all differences between the plan for Australia and the submitted EU, global or core RMP (See Australian‐specific Annex to the EU RMP).

Risk management plans for biologicals should include additional sections about possible risks specific to a biological. Refer to Additional requirements for RMPs for biologicals.

Provide an EU RMP

You should provide an unadapted EU RMP (if one exists), including V.B.8.6 RMP Module SVI: Additional EU requirements for the safety specification.
If no EU RMP exists, and you submit an alternative RMP (for example, a global or core RMP):

  • ensure it covers all the modules of the EU RMP
  • preferably, present it in the current EU RMP format

Additional requirements for RMPs for biologicals

In a Risk Management Plan for biologicals, include discussion of possible risks specific to biologicals that may not apply to other therapeutic products. Refer to:

  • EMA/838713/2011 Guideline on good pharmacovigilance practices (GVP) Module V — Risk management systems (with the exception of section V.C.3.1‐Requirements in specific situations)
  • EMEA/149995/2008 Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products, which contains guidance about:
    • the possible risks specific to biologicals
    • biovigilance, efficacy follow-up and risk minimisation activities of particular relevance to biologicals

The concepts and information in these EMA guidelines are applicable to biologicals, despite the EMA guidelines being focused on medicines and advanced therapy medicinal products (ATMPs), which include a narrower group of products than those regulated under the Australian biologicals framework.

The following information is required for RMPs for biologicals. These additions may be included in the EU RMP or included as an attachment to the Australian-specific annex.

If an RMP section is not applicable to a particular product, do not omit the section, but instead state this in the RMP and provide a justification.

  • Consider the specific risks of biologicals. This can be in the safety specification in the EU RMP or in a separate attachment to the Australian-specific annex. For guidance on risks to address refer to:
  • EMEA/149995/2008 Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products, Section 8.1 Safety specifications.
  • Include a section ‘Evaluation of the need for efficacy follow-up' in either RMP Part II or attached to the Australian-specific annex. When a need for efficacy follow-up is identified, the efficacy follow-up plan should be included in Annex 9 of the RMP or as an attachment to the Australian-specific Annex. Refer to:
  •  EMEA/149995/2008 Guideline on safety and efficacy follow-up – risk management of advanced therapy medicinal products, Section 8.4 Evaluation of the need for efficacy follow-up.
  • Provide a detailed description of the sponsor's biovigilance system in Australia either in the Australian-specific Annex (where an EU, global or core RMP is provided) or in RMP Part III Pharmacovigilance plan (when an Australian RMP is provided). Refer to:
  • Biovigilance responsibilities of sponsors of biologicals: Australian requirements and recommendations (under development).

The description of the biovigilance system should include:

    • a summary of the sponsor's routine biovigilance activities
    • details of the elements of the biovigilance system needed to support the additional biovigilance activities included in the RMP
    • details of procedures for traceability of products from donor to recipient, and recipient to donor, to investigate and act on possible disease transmission
  • In the biovigilance plan described in RMP Part III or in the Australian-specific annex,   include consideration of safety follow-up issues relevant to biologicals. Refer to:
  • EMEA/149995/2008 Guideline on safety and efficacy follow-up – risk management of advanced therapy medicinal products, Section 8.3 Pharmacovigilance plan (incorporating safety follow-up)
  • When developing the risk minimisation plan, consider the guidance provided on reducing particular risks of a biological product. Refer to:
  • EMEA/149995/2008 Guideline on safety and efficacy follow-up – risk management of advanced therapy medicinal products, Section 8.5 Risk Minimisation plan

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