Tag Archives: EU

Europe: More Direct-Acting Antivirals, More Controversy

The storms raging across Europe—and beyond—over the pricing of new hepatitis C treatments have been intensified by the European Union’s approval last week of the latest directly-acting antiviral, Bristol-Myers Squibb’s Daklinza (daclatasvir). Just two months after the European Medicines Agency gave a positive opinion on the drug, the formal authorization was delivered for use in […]
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60 Years of Pharma Regulation in Europe

European regulation of pharmaceuticals has, since the foundation of the European Union around 60 years ago, been a story of medicines being controlled in a collaboration between regulators at the EU and national levels. In recent years, this collaboration has been extended to involve not just the regulators themselves but also other stakeholders such as […]
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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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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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European Pharma Races to Catch Up with Data Protection

The European Union’s struggle to bring its data protection rules into the 21st century continues—haltingly—as the EU itself enters its new era, with a new European Parliament, a new President-designate of the European Commission, and a new European Commission due to take office in November. This has left the pharmaceutical sector, already out of breath […]
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