Risk management plans for medicines and biologicals
What to include in the RMP
An RMP submission that is acceptable for evaluation will contain the following:
- study protocols (or current drafts) for all studies referred to in the product vigilance or risk minimisation plans: the aims, methodology, limitations and practical applications
- all attachments, annexes and appendices referred to in the RMP, in full (see Mandatory requirements for an effective application)
- plans for all communication and/or education programs proposed as risk minimisation activities, including aims of the program, methods, evaluation or monitoring of the effectiveness of the program, and timelines for the provision to the TGA of relevant documents (for example: health professional and consumer letters, educational materials)
- timelines for planned activities, for example estimated start, end and reporting dates for planned studies, or communication program milestones
This is necessary to allow us to assess the appropriateness and value of the planned activities.
If you anticipate an updated RMP will be available during the evaluation process, please identify this in the RMP documentation (for example, by including the due date for the updated RMP).
Examples of activities or interventions that may be included
Various activities may be considered, for example:
- Additional pharmacovigilance activity - an observational cohort study to further identify the occurrence of adverse events that were equivocal or not observed during pre‐marketing trials. Although not detected during product development, they may be associated with the class of medicine, and therefore represent a potential safety concern
- Risk minimisation activities - beyond the routine these may include communication programs, such as providing educational material to prescribers or performing specific tests. For instance, where a medicine is suspected to be teratogenic, there may be a requirement to perform a pregnancy test prior to prescription, and to ensure adequate contraception.
Any additional risk minimisation activity needs to include a detailed outline of how the effectiveness of the activity to minimise the risk will be evaluated. Examples of measures to assess this include:
- cross sectional surveys with results evaluated against established criteria
- post‐authorisation studies
If an educational program is accredited with a learned college, this usually includes/provides an acceptable measure of effectiveness of risk minimisation activity.
Guidance on the measurement of the effectiveness 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.