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Risk Management for Medicinal Products in the EU
Over the last few decades many important pharmacovigilance issues
have been identified through spontaneous reporting of adverse drug
reactions. At the same time, consideration has been given to ways
in which the current reporting systems might be augmented and strengthened.
A strong contender is that planning of pharmacovigilance activities
might be improved if it were more closely based on product specific
issues identified from pre- or post-authorisation data and from pharmacological
principles. Such planning would also guide the use of routine electronically
collected data within health services to provide rapid investigation
of predicted or emerging safety concerns.
In 2005, new Community Legislation introduced a requirement for
the submission in the application for authorisation of a medicinal
product, of the risk management system, when appropriate, by applicants
and/or marketing authorisation holders.
A risk management system is as a set of pharmacovigilance activities
and interventions designed to identify, characterise, prevent or
minimise risks relating to medicinal products, including the assessment
of the effectiveness of these interventions. A risk management system
for an individual medicinal product or a series of medicinal products
can be presented to Competent Authorities in the form of an EU Risk
Management Plan.Information on the format, contents and when it should be submitted can be found in Module V – Risk management systems of the guidelines on good pharmacovigilance practices (GVP).
Risk management is a continuing process throughout the life-cycle
of a medicinal product. A medicine is authorised on the basis that
in the specified indication(s), at the time of authorisation, the
benefit-risk is judged positive for the target population. However,
not all actual or potential risks may have been identified when an
initial authorisation is sought. In addition, there may be subsets
of patients for whom the risk is greater or different than that for
the population as a whole.
The management of a single risk consists of four steps, risk detection,
risk assessment, risk minimisation and risk communication. However,
a typical individual medicinal product will have multiple risks attached
to it and individual risks will vary in terms of severity, and individual
patient and public health impact. Therefore, the concept of risk
management must also consider the combination of information on multiple
risks with the aim of ensuring that the benefits exceed the risks
by the greatest possible margin both for the individual patient and
at the population level.
More information about Risk Management in the EU can be found in:
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Last update: Monday, 26 October 2015.