Guideline provides for a harmonised approach across Europe when dealing with requests for access to marketing authorisation applications The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have adopted a joint guidance document, providing for the first time for a consistent Europe-wide approach to the identification of commercially confidential information and personal [...]

Strengthened policies on handling of conflicts of interest Following its implementation in September 2011, the Management Board reviewed the initial experience with the Agency’s revised policy on the handling of conflicts of interest for scientific-committee members and experts. The Board endorsed a proposal from the Executive Director to further strengthen the policy taking into account [...]

The European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control (ECDC) have published the second joint EU report on antimicrobial resistance in zoonotic bacteria affecting humans, animals and food. The report makes an important contribution to current work being carried out at EU-level to fight antimicrobial resistance. EFSA and ECDC [...]

The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its applications for an extension of the therapeutic indication for the centrally authorised medicines Exelon and Prometax (rivastigmine), 4.6 mg/24 h and 9.5 mg/24h transdermal patches. On 30 March 2011, Novartis Europharm Ltd submitted an application to extend [...]

The European Medicines Agency has been formally notified by Alkermes Pharma Ireland Limited of its decision to withdraw its application for a centralised marketing authorisation for the medicine Megestrol Alkermes (megestrol), 125 mg/ml oral suspension. Megestrol Alkermes was intended to be used for the treatment of anorexia, cachexia or an unexplained significant weight loss in [...]

Hygiene Worldwide H5N1 Avian Bird Flu is a type of influenza virus that is hosted by birds, but strains of avian influenza virus has already affected pigs, horses, seals, whales and humans.Avian Influenza can survive for considerable lengths of time outside of the host and birds are infected through contact with other birds, vehicles and [...]

The European Food Safety Authority (ESFA) is today launching a pilot project allowing Observers to attend some meetings of its Scientific Committee and a number of its Scientific Panels. Underpinning EFSA’s commitment to openness and transparency, the pilot phase aims to promote better understanding of how scientific risk assessment works at EFSA and to provide [...]

The European Food Safety Authority (EFSA) has published implementing rules related to Declarations of Interest (DOIs), one of the cornerstones of its recently adopted Policy on Independence and Scientific Decision-Making Processes. The rules related to Declarations of Interest (DOIs) continue to strengthen the procedures in place for screening and managing interests declared by those involved [...]

The European Food Safety Authority (EFSA) has published implementing rules related to Declarations of Interest (DOIs), one of the cornerstones of its recently adopted Policy on Independence and Scientific Decision-Making Processes. The rules related to Declarations of Interest (DOIs) continue to strengthen the procedures in place for screening and managing interests declared by those involved [...]

Mandatory data set to be submitted by 2 July 2012 The European Medicines Agency has published an updated set of mandatory requirements for marketing authorisation holders to comply with Article 57(2), one of the key measures of the new pharmacovigilance legislation. The Agency has considerably reduced the number of data fields initially required in the [...]