The Process Of Regulatory Pharmacovigilance In The Eu

Regulatory pharmacovigilance is dependent on the availability of information on the clinical effects of medicines in representative populations as used in normal practice. In addition to systems for collecting and handling suspected ADRs, processes for generating and investigating signals are necessary. All potentially important hazards are investigated with a view to taking appropriate action based on the available scientific evidence. The most important outputs of the process are actions to promote safer use of medicines. These include, for example, introducing warnings, contraindications, information on adverse effects or changes to dosing recommendations. Indications or methods of supply may be also restricted, although withdrawal of a medicinal product from the market on safety grounds is relatively unusual (Jefferys et al., 1998). Informing users and explaining the reasons for the action taken is a critical determinant of the effectiveness of these measures. The process of regulatory pharmaco-vigilance is summarised in Figure 14.1.

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