Improving patient safety through more proactive risk management

News 29/02/2016

Revised good pharmacovigilance practices module on risk management systems released for public consultation

The European Medicines Agency (EMA) has published today a revision of PDF icon module V of the good pharmacovigilance practices (GVP) on risk management systems for public consultation until 31 May 2016.

Risk management is a major component of the safety monitoring of medicines. Risk management entails putting in place measures to minimise potential risks and to fill knowledge gaps for medicines (e.g. through post-authorisation data). The goal is to ensure that throughout its lifespan the benefits of a particular medicine exceed the risks by the greatest achievable margin. Marketing authorisation holders are required to present the proposed activities in a risk management plan (RMP) that needs to be approved by the regulators before a medicine can be authorised.

GVP module V, released in 2012, advises developers of medicines, marketing authorisation holders and regulators on the design of effective risk management systems and plans. This first major revision is based on the experience gained since the Agency's Pharmacovigilance Risk Assessment Committee (PRAC) started its operations, which includes the review of risk management plans. It further clarifies the activities a risk management plan should focus on during the life cycle of a product. This will help to ensure that a risk-proportionate planning of activities directs resources to areas where the need for additional information and risk minimisation is greatest. GVP module V highlights principles of risk minimisation and therefore, should be read in conjunction with PDF icon GVP module XVI which focuses on tools for risk minimisation.

Together with the GVP module V, EMA is also consulting stakeholders on an Microsoft Office document icon amended RMP template , to be used by medicine developers. The revision of the RMP template is based on the principles described in the updated GVP module V in the view of getting a focussed risk management system and simplifying the way information is submitted to the regulators. The RMP template includes a format for a summary of the RMP to be made public, and this format incorporates improvements following a one-year pilot phase. The RMP summary aims at further streamlining and contextualising the information and to better meet the information needs and expectations of interested stakeholders.

Comments on the GVP module V should be provided using this template. The completed comments form should be sent to by 31 May 2016.

Comments on the RMP template should be provided using this . The completed comments form should be sent to by 31 May 2016.

After comments have been received from stakeholders during the public consultation, the Agency will publish the final versions of the GVP module V and the RMP template together with an implementation plan. Until this time the current versions of the GVP module V and the RMP template remain applicable.

GVP modules are a set of guidelines to facilitate and strengthen pharmacovigilance in the EU. They apply to marketing authorisation holders, the Agency and medicines regulatory authorities in EU Member States and aim to improve safety for patients. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

The release of the GVP modules is a key deliverable of the 2010 pharmacovigilance legislation. Each module was developed by a team of experts from the Agency and from EU Member States.

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