EMA to Conduct Safety Review of EU and Nationally Approved Drugs

The European Medicines Agency (EMA) has announced a milestone safety review of drugs approved through both the centralized EU procedure and the national procedure, based on the active substance that a drug contains.

The review is slated to begin on 1 April 2013. Until now, the agency's review of the safety of marketed drugs has been limited to medicines authorized through the centralized procedure.  EMA's expanded authority to undertake such a review was granted by European pharmacovigilance legislation enacted in 2010.  The agency will not conduct a safety review of drugs that were solely approved through a national procedure "until after 2013." 

Periodic safety update reports (PSURs) submitted by marketing authorization holders will be the basis for the safety review, EMA said. PSURs are reports that provide an evaluation of a drug's benefit-risk balance, and are submitted by marketing authorization holders at defined time points following a product's authorization. The EMA uses the information in PSURs to determine if new risks have been identified for a drug or whether a product's risk-benefit balance has changed in order to evaluate the need for further investigation or measures to protect the public from harm.

In October 2012, EMA published a list of EU reference dates and frequency of submission of PSURs for active substances contained in medicines in the EU, known as the 'EURD list'. Marketing-authorization holders for drug products that contain the active substances listed must submit PSURs to both national authorities as well as EMA according to the dates published in the list.  The PSUR work sharing and synchronization project has developed the list of active substances found only in nationally authorized medicines.