Medical
literature is an important source of information on suspected adverse reactions
reported on medicines. The European Union's (EU) pharmacovigilance legislation
has given EMA responsibility for the monitoring of selected medical literature
for a defined list of active substances used in medicines and for entering
identified reports of suspected adverse reactions in EudraVigilance, the EU
adverse drug reaction collection and management system.
This
initiative aims to improve the safety monitoring of medicines by enhancing the
quality and consistency of data reported in EudraVigilance. It is provided as a
service to industry which, for the active substances and literature covered by
the EMA activities, will no longer be obliged to enter the information on
suspected adverse reactions into EudraVigilance. Individual cases of suspected
adverse reactions found in the literature will be made available to
marketing-authorisation holders so they can include them in their safety
databases and meet their reporting obligations outside the European Economic
Area.
Posted by Tim Sandle
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