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170 Current news of European Medicines Agency


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EMA to relocate to Amsterdam

Working with Dutch government to ensure successful move by end of March 2019


The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands. This decision was taken today by the EU 27 Member States in the margins of the General Affairs Council (Art.50). The Agency now has just over 16 months to prepare for the move and take up its operations in ...


EMA prepares for Brexit

Business continuity plan aims to preserve Agency’s ability to protect public and animal health


The European Medicines Agency (EMA) has developed and initiated a business continuity plan to deal with the uncertainty and workload implications linked to the United Kingdom’s (UK’s) withdrawal from the European Union (EU) and the Agency’s relocation. “Preparing for the move, managing the ...


EMA’s CHMP Issues Positive Opinion for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma

Decision by the EC is expected in the third quarter of 2017


Merck and Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of avelumab (BAVENCIO®) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and ...


Highlights of June 2017 EMA Management Board meeting

Focus on Brexit preparations and the development of the EU clinical trial portal and database


Brexit preparations The Management Board of the European Medicines Agency (EMA) was updated on the Agency’s preparation for the withdrawal of the United Kingdom (UK) from the European Union (EU). Further to the UK’s invocation of Article 50 on 29 March 2017, EMA needs to prepare and is working on ...


EMA and heads of national competent authorities discuss consequences of Brexit

Key principles and working methodology established


The European Medicines Agency (EMA) organised an information meeting yesterday with members of its Management Board and heads of the National Competent Authorities (NCAs) of the EU/EEA Member States. The goal was to start discussing how the work related to the evaluation and monitoring of ...


New judicial decisions at odds with EMA’s efforts to allow access to documents on medicines

EMA appeals interim measures


The European Medicines Agency (EMA) has appealed two interim orders by the President of the General Court of the European Union (EU) to suspend the release of documents requested by third parties under Regulation (EC) no. 1049/2001, the so-called “Transparency Regulation”. The first order blocked ...


Merck Receives EMA Acceptance for Review of Marketing Authorization Application for Cladribine Tablets


Merck announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) of the investigational product Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS). “Our submission of the Marketing Authorization ...


Regulation of advanced therapy medicines

Report details concrete proposals to encourage development and authorisation of ATMPs in the EU


The European Medicines Agency (EMA) today published a report from a multi-stakeholder expert meeting held on 27May 2016 to explore possible ways to foster the development of ATMPs in Europe and expand patients’ access to these new treatments. ATMPs comprise gene therapies, tissue engineered ...


“EMA ready to address challenges ahead”


Executive Director Guido Rasi outlined his vision for his five-year mandate at the helm of the European Medicines Agency (EMA), at a press briefing today. Among the current shifts in medicines development, Professor Rasi mentioned the vast progress made in the understanding of the human body and ...


Merck and Pfizer Receive Positive Opinion from EMA Committee


Merck and Pfizer announced that the European Medicines Agency (EMA)’s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion for Orphan Drug designation (ODD) for avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, pending an official decision by ...


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