Group Calls for EU Pharmacovigilance Regulations to Cover Unlicensed Medications

Posted 21 March 2012 | By Alexander Gaffney, RAC 

A coalition of patient groups is calling for the inclusion of unlicensed medication in the next version of the Pharmacovigilance Directive, reports The Pharma Times.

The call, led by the European Alliance for Access to Safe Medicines (EAASM), is in response to reports of adverse events occurring with off-label drugs, including Avastin (bevacizumab).

"The Alliance says urgent action is needed to address patient safety issues around the use of unlicensed and off-label medicines, which it says should only be used in cases where there is no licensed product available that meets the medical need," writes The Pharma Times.

Among the proposals called for by EAASM:

  • a system to track adverse events in off-label medicinal use
  • professional codes of practice to mandate reporting of off-label adverse events
  • public awareness of off-label prescribing

EAASM has reportedly already met with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) regarding its proposals, and found MHRA to be amicable to its requests.

Read more:

The Pharma Times - EU pharmacovigilance reg "must cover unlicensed medicines"

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