Tag Archives: European Medicines Agency

"Work to Be Done" on EU Clinical Trials Regulation, Says Industry

The European Parliament yesterday voted towards the adoption of the new Clinical Trials Regulation, which removes the legal framework for pharma to not publish its data by stating that information from  trial study reports should not be considered commercially confidential.
Posted in Europe, Global, Regulatory | Also tagged , , , | Leave a comment

Adaptive Licensing: The Start of a Slow Revolution in Europe

By Peter O’ Donnell. So at last it’s happened. Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation. Is this the beginning of the end of binary decision-making on the merits of a new medicine? Has a half-century of the “yes/no” authorization process peaked, to be replaced […]
Posted in Europe, Global, Guest Blog, Op-Ed, R&D, Regulatory, Safety | Also tagged , , , , | Leave a comment

EMA Clarifies Marketing Authorization Categories

The European Medicines Agency (EMA), in agreement with the European Commission, has released an updated question and answer document clarifying a number of issues related to the new categories of variations to the terms of marketing authorizations that were introduced by the agency in August 2013. The Commission guidelines on variations to marketing authorizations of […]
Posted in Europe, Regulatory | Also tagged , | Leave a comment

The EMA Turns 20: What Does It Want to Be?

Reflector looks at the growing pains of the European Medicine Agency (EMA) as it faces the key policy challenges of 2014. The European Medicines Agency (EMA) is 20 years old this year — and it confronts many of the problems familiar to anyone at that age. After the vigorous growth and boundless optimism of its […]
Posted in Europe, Global, Regulatory | Also tagged , , , , | Leave a comment

The European Regulatory Outlook for 2014

Pharm Exec’s EU correspondent, Reflector, looks at some of the European regulatory developments earmarked for 2014 and anticipates their effect on the industry. Personnel Some of the big influences on the pharma industry in Europe next year — and for several years to come — will be the big changes upcoming in key personnel in […]
Posted in Europe, Global, healthcare, R&D, Regulatory | Also tagged , , , , , , , , | Leave a comment
  • Categories

  • Meta