Press Release: Council ensures funding of strengthened monitoring of medicines

On 8 May 2014, the Council approved a draft regulation aimed at ensuring the funding of strengthened post-authorisation monitoring of medicines for human use ("pharmacovigilance") conducted at EU level. That followed a first-reading agreement reached with the European Parliament in February 2014.

The EU rules on pharmacovigilance had been reinforced in 2010 and, following the Mediator case, in 2012. The agreement endorsed that day was expected to provide the means to finance the work of addressing the safety concerns and maintain high standards of quality, safety and efficacy of medicinal products.

• Primary Source

Website: European Medicines Agency http://www.ema.europa.eu/ema/

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