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Latest News | 25 March 2013

EMA Recommends Limiting Indication of Cilostazol-Containing Medicines Because of Risks

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A warning issued by the European Medicines Agency (EMA) on 22 March 2013 cautions healthcare providers and the public not to use cilostazol-containing medicines to treat intermittent claudication, a Read More...


Latest News | 18 March 2013

Centralized Procedure to see Simplified Submission Process, Says EMA

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The European Medicines Agency (EMA) has announced that it has simplified the process by which marketing authorization applications (MAAs) are submitted to the agency, reducing the number of Read More...


Latest News | 19 December 2012

EMA Announces Huge Overhaul of Operations, Processes

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The European Medicines Agency (EMA) is preparing to reorganize its operations, processes and offices in 2013, it has announced.In a statement released on its website on 19 December 2012, the agency Read More...


Latest News | 22 October 2012

CHMP Appoints New Vice-Chair

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The European Medicines Agency (EMA) has appointed Ian Hudson as the new vice-chair of its Committee for Medicinal Products for Human Use (CHMP) after its previous vice-chair was appointed to the Read More...


Latest News | 2 October 2012

After Failures, EMA Calls for Overhaul of Existing Obesity Treatment Guidance

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A new concept paper released by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) seeks to establish an updated framework for anti-obesity and weight control drug Read More...


Latest News | 17 September 2012

CHMP Elects New Leader after Atypical Transition

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The European Medicines Agency (EMA), currently in the midst of a number of changes in committee staff, has elected Thomas Salmonson as the new chair of its influential Committee for Medicinal Products Read More...


Latest News | 20 July 2012

CHMP Recommends EU's First Gene Therapy Product

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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended for use the first gene therpy product in the European Union, regulators said Friday, 20 Read More...


Latest News | 25 May 2012

EMA Recommends Vertex's Cystic Fibrosis Drug Kalydeco

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The European Medicines Agency (EMA) has recommended Vertex Pharmaceuticals' cystic fibrosis (CF) drug Kalydeco (ivacaftor), moving the drug one step closer to becoming the drug the first in Europe for Read More...


Latest News | 4 May 2012

EMA Adopts Guidance on Medical Products Containing Genetically Modified Cells

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The European Medicines Agency (EMA) announced 5 May it has adopted a scientific guideline on aspects relating to the development and testing of medicinal products containing genetically modified Read More...


Regulatory Update | 17 April 2012

Europe: EMA Releases New 'Practical Guidance' on Foreign Clinical Trials

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The European Medicines Agency (EMA) yesterday (16 April) published guidance, in the form of a final reflection paper, on ethical and good clinical practice (GCP) aspects of clinical trials conducted Read More...


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