Tag Archives: regulation

Major Changes to EU Clinical Trials Regulation

Earlier this year, the newly approved EU Clinical Trials regulation (No 536/2014) was published in the Official Journal of the EU (OJEU).  The European Commission (EC) estimates that all the changes could save researchers €800 million (over $1 billion) a year. It replaces the existing EU Clinical Trials Directive (2001/20/EC), which was intended to simplify […]
Posted in Europe, Global, Guest Blog, R&D, Regulatory | Also tagged , , , | Leave a comment

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 […]
Posted in Europe, Regulatory, Safety | Also tagged , | Leave a comment

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 […]
Posted in Europe, Global, R&D, Regulatory | Also tagged , , , | Leave a comment

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, […]
Posted in FDA, Legal, Market Access, Marketing, Regulatory, Safety | Also tagged , , , , , , , , , , , , , , , , | Leave a comment

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 […]
Posted in Europe, Global, Regulatory | Also tagged , , , , , , | Leave a comment
  • Categories

  • Meta