Tag Archives: EMA

EMA Delays Adoption of Policy on Publishing Trial Data

The European Medicines Agency (EMA) has postponed formal adoption of the policy on publication of clinical trial data. An EMA press statement said that “[f]urther clarifications on wording and practical arrangements will be discussed by Board members”, whose additional contributions will now be considered with a view to reaching final agreement at the Management Board meeting on 2 October. […]
Posted in Europe, Global, R&D, Regulatory | Also tagged | Leave a comment

Industry Challenged: “Do More for Teenagers with Cancer”

By Leela Barham. Accessing the latest cancer drugs always seem to be controversial. Not just because of the money but also because of the complexities of accessing treatments during their development. This seems to be especially the case for young people with cancer, according to the UK’s Teenage Cancer Trust. 
Posted in Europe, Global, Guest Blog, R&D | Also tagged , , | Leave a comment

EMA to Review Safety of Ibuprofen Medicines

The European Medicine Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines.
Posted in Europe, Global, Regulatory, Safety | Also tagged , , , , | Leave a comment

EU Steps Up Manufacturing Inspection Efforts

One of EMA’s key objectives this year is improvements in dealing with the “causes and impact of shortages of human medicines caused by GMP non-compliance and quality defects”. The European Directorate for the Quality of Medicines & Healthcare, which is responsible for the European Pharmacopoeia but also runs its own inspection operations, has been tightening […]
Posted in Europe, Guest Blog, Manufacturing, Regulatory | Also tagged , , , | Leave a comment

The European Medicine Agency’s Transparency Dilemma

By Peter O’Donnell, Applied Clinical Trials. The European Medicines Agency thought it might at last be back on the road to salvation when Guido Rasi swept into town in 2011 and started ordering greater transparency in the agency’s operations. He was determined to seek a new type of trust with the agency’s various publics—and particularly […]
Posted in Europe, Guest Blog, Op-Ed, Regulatory | Also tagged , , | Leave a comment
  • Categories

  • Meta