TQMC Network: EMA and usFDA

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The European Medicines Agency is a decentralised body of the European Union, located in London.

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24/09/2010
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 20-23 September 2010
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24/09/2010
European Medicines Agency recommends suspension of Octagam in all EU Member States
CHMP recommendation based on risk of thrombo-embolic reactions ... Read more
23/09/2010
European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim
The European Medicines Agency today recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim. These medicines will stop being available in Europe within the next few months. ... Read more
23/09/2010
European Medicines Agency confirms positive benefit-risk balance of RotaTeq
Very low levels of porcine circovirus type 2 DNA fragments in the oral vaccine pose no risk to public health ... Read more
23/09/2010
European Medicines Agency updates on the review of Pandemrix and reports of narcolepsy
Available evidence does not confirm a link; more research needed ... Read more
22/09/2010
European Medicines Agency welcomes adoption of new pharmacovigilance legislation by European Parliament
The European Medicines Agency welcomes the adoption of the new pharmacovigilance legislation by the European Parliament today. This is a major step towards the legislation coming into force, currently expected for mid-2012. ... Read more
20/09/2010
Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 14-16 September 2010
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17/09/2010
European Medicines Agency publishes first review of orphan designation
The European Medicines Agency has published the first of its ‘review of orphan designation’ documents. These documents summarise the review of the orphan designation carried out by the Committee for Orphan Medicinal Products (COMP) whenever an orphan medicine reaches marketing authorisation. ... Read more
17/09/2010
Novartis Europharm Ltd withdraws its marketing authorisation application for Rasival (aliskiren/valsartan)
The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Rasival (aliskiren/valsartan), 150/160 mg and 300/320 mg film-coated tablets. ...Read more
15/09/2010
European Medicines Agency and U.S. Food and Drug Administration extend confidentiality arrangements indefinitely
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have extended their confidentiality arrangements related to medicinal products for human and veterinary use, following the positive experience gained since the initial arrangements were signed in September 2003. This cooperation will now continue indefinitely without the need for further renewal. ... Read more
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