Tag Archives: regulation

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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EU Clinical Trials Agreement 'Compromised', Says Industry

European Union (EU) regulators reached agreement today on the much-vaunted Clinical Trials Regulation. The regulation harmonizes the rules for the conduct of clinical trials in the EU and the ‘acceptability’ of the resulting data, and palces further safeguards on the safety of trial subjects. The legislation’s aim is to facilitate and expedite the authorization procedure […]
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Mutual v. Bartlett: A Line in the Sand on Side Effects

The Supreme Court ruled last Monday in the case of Mutual Pharmaceuticals v. Bartlett that generic drug makers cannot change labeling or the formula of a drug after it has been approved by the FDA. The majority, which included Justices Alito, Roberts, Scalia, Kennedy, and Thomas, concluded that federal regulation trumps state tort liability law, […]
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The EU Pharma Switch

The chair of the first session of the joint meeting between the European Medicines Agency (EMEA) and The Organization for Professionals in Regulatory Affairs (TOPRA) in London this week was quick to point out that the event was not scheduled to coincide with last Friday’s announcement that European Commission (EC) responsibility for EMEA is finally […]
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Europe: Go Easy on Your Pharma Lobbyists

European pharmaceutical executives are sometimes heard to complain that their public affairs departments are not doing a good job for them, and that their industry associations are a waste of time and money. A report published in Brussels earlier this month suggests that this judgment may be excessively harsh. Lobbyists for healthcare and pharmaceuticals score […]
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