Tag Archives: EMA

Global Gaps in Standards Threaten Biosimilar Development

Although biopharmaceutical companies and regulatory authorities have made considerable progress in establishing policies for bringing biosimilars to market, key differences and gaps in requirements for testing and documenting product similarity still characterize the European Union, the U.S. and other regions. The EU’s European Medicines Agency (EMA) has set the regulatory pace, with 18 products approved since 2006, […]
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Europe Leads Generic-Drugs Assessment Project

The European Union’s  decentralized procedure is to be used by international regulatory agencies as a model for facilitating generic-drug application assessments, as part of the International Generic Drug Regulations Pilot (IGDRP) project. At the request of a generic-drug company, the EU will share assessment reports in real time with collaborating international regulatory agencies. According to […]
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EMA Invites Comments on Good Biomarker Practice

The European Medicines Agency (EMA) has released a consultation on good genomics biomarker practices. The outcome of the consultation will inform a guideline, which will set criteria to underpin the generation of robust clinical genomic datasets throughout a medicine’s lifecycle,  the choice of genomic techniques and biomarkers, the impact on the relevant study design, and the […]
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EMA Invites Comments on Guidance for Flu Vaccines

The European Medicines Agency (EMA) has released the second module of a new overarching guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication in April of […]
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The European Parliament’s New Term: What Can We Expect?

As Europe departs for its annual holiday—sacrosanct, even amid the continuing economic woes, the multiple crises in the Middle East, and the dark mysteries of Russia’s intentions in its former satellites—the question remains unresolved as to what to expect from the new European Parliament in the new term. Philip Ward considers the options in this […]
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