EMA Issues Risk Management Module

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-02-2016 09:24


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

GVP Module V, released in 2012, advises developers of medicines, marketing authorization 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 lifecycle 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 minimization is greatest," said the EMA. The GVP Module V highlights principles of risk minimization and therefore, should be read in conjunction with GVP module XVI which focuses on tools for risk minimization.

Together with the GVP Module V, the EMA is also consulting stakeholders on an amended risk management plan (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 focused 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 contextualizing the information and to better meet the information needs and expectations of interested stakeholders.

After comments have been received from stakeholders during the public consultation, the EMA 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 European Union (EU). They apply to marketing authorization holders, the agency and medicines regulatory authorities in EU member states and aim to improve safety for patients. They cover medicines authorized centrally via the agency as well as medicines authorized at the national level.

Source: EMA


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