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News New fees for marketing authorisation applications in force
The European Medicines Agency reminds applicants that revised implementing rules on fees payable to the Agency apply as of 7 October 2010. |
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News European Medicines Agency strengthens rules on conflicts of interests of its scientific experts
The European Medicines Agency has published new rules on how the Agency will be handling potential conflicts of interests of its scientific experts, following endorsement by its Management Board on 7 October 2010. |
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News European Medicines Agency reviews treatment recommendations for Fabrazyme
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reviewed its previous recommendations on the use of Fabrazyme (agalsidase beta) during the ongoing supply shortage. This was triggered by an increase in reported adverse events in patients treated with the lower dose of Fabrazyme that has been introduced during the shortage. |
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News European Medicines Agency recommends use of fibrates as second-line treatment
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of the four fibrates bezafibrate, ciprofibrate, fenofibrate and gemfibrozil continue to outweigh their risks in the treatment of patients with blood lipid disorders. |
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News European Medicines Agency concludes that benefit-risk balance of Invirase remains positive
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reviewed all available data on Invirase (saquinavir) and the potential risk of arrhythmia, and concluded that the benefit of the medicine continues to outweigh its risks. |
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News European Medicines Agency receives 1,000th application for a Paediatric Investigation Plan or Waiver
The European Medicines Agency has received and validated the 1,000th application for a Paediatric Investigation Plan (PIP) or Waiver since its Paediatric Committee was established in July 2007. |
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News European Medicines Agency Management Board adopt new policies on handling of conflicts of interests and on access to documents
The European Medicines Agency’s (EMA) Management Board adopted a number of important policies at its 68th meeting. |
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News European Medicines Agency publishes first review of orphan designation
The European Medicines Agency has published the first of its ‘review of orphan designation’ documents. |
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News 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. |
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News European Medicines Agency holds international workshop on clinical trials in the context of global medicines development
On 6-7 September 2010 the European Medicines Agency (EMA) held an international workshop with a broad cross section of stakeholders from around the world to discuss a way forward for a global framework of clinical trials that has at its heart the protection of the rights, safety and wellbeing of patients participating in clinical trials anywhere in the world. |
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News European Medicines Agency holds first scientific workshop on nanomedicines
European and international experts prepare for the evaluation of future nanomedicines |
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News European Medicines Agency starts review of Pandemrix
Agency is investigating whether there is a link between vaccine and cases of narcolepsy |
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News EMA and US FDA seek potential candidate companies for joint GMP inspection programme
The European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. |
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News European Medicines Agency concludes review of modified-release oral opioids of the WHO level III scale for the management of pain
Benefits of most of these medicines outweigh risks; marketing authorisations of opioids using polymethacrylate-triethylcitrate controlled release systems should be suspended because of concerns over interaction with alcohol |
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News European Medicines Agency update on ongoing benefit-risk review of Avandia, Avandamet and Avaglim
Doctors reminded to follow current restrictions for rosiglitazone-containing anti-diabetes medicines until further notice |
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News European Medicines Agency recommends restricting the use of modafinil
Doctors and patients advised to use modafinil for treatment of narcolepsy only; all other indications to be removed from product information |
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News European Medicines Agency confirms positive benefit-risk balance of topical formulations of ketoprofen
Doctors to inform patients how to use these medicines appropriately |
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News European Medicines Agency confirms positive benefit-risk balance of Rotarix
Porcine circovirus type 1 in the oral vaccine poses no risk to public health |
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News Agency publishes policy on communicating safety issues for human medicines
A new policy on communicating safety-related issues on medicines for human use has been published by the European Medicines Agency (EMA). |
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News European Medicines Agency starts review of rosiglitazone-containing medicines
New studies question cardiovascular safety of anti-diabetes medicines |
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News European Medicines Agency and European Commission start reflection process on way forward for the Agency and the network
Conference on outcomes of evaluation of the European Medicines Agency brings together some 150 partners and stakeholder representatives |
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News European and international experts discuss the way forward in stem-cell research and development
European Medicines Agency hosts first workshop on stem cell-based therapies |
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News European paediatric research network ready to start
European Medicines Agency asks interested networks to start self-assessment process; operational structure agreed with networks |
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News European Medicines Agency gives new temporary treatment recommendations for Fabrazyme
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has been informed by Genzyme, the manufacturer of Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta), that the supply shortages for these medicines are expected to continue at least until the end of September 2010, because of a new manufacturing problem. |
