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EMA expands adverse event reporting website

Opens it up to all nationally-authorised medicines
EMA expands adverse event reporting website

The EMA has expanded the remit of its adverse event reporting website – allowing patients, the public and healthcare professionals to report suspected side effects on any nationally-authorised medicine.

The move allows any problems with an additional 1,700 active substances to be reported on www.adrreports.eu, which was first launched in 2012 and previously accepted suspected side effects associated with centrally authorised medicines.

In addition to filing reports on suspected problems with medicines, the site also lets the public obtain information on suspected adverse drug reactions - ie, those that have been reported but may not be related to, or caused by, the medicine.

The EMA said in a statement: “Spontaneous reports of suspected side effects provide regulatory authorities with important information which is used to monitor the safety of a medicine.”

The reports are sent electronically to the EMA”s EudraVigilance database of suspected side effects and each report on the public website provides aggregated data that can be viewed by a patient's age and sex, the type of suspected side effect and its outcome.

Wide-reaching changes to the EMA's approach to pharmacovigilance in 2012 significantly increased the number of side effects that patients reported directly to either national regulatory authorities or pharma companies within the European Economic Area.

EudraVigilance received 35,600 patients reports in the 2013, compared to 21,600 in 2011 - the year before the pharmacovigilance changes came into effect.

15th October 2014

From: Regulatory

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