Tag Archives: EMA
By Guest Blogger | Published: April 28, 2014
New data maintenance guidelines have sparked a flurry of activity in Europe. Organizations are still grappling with electronic submissions, and the need to update data is intensifying the pressure. But there is an upside, says Miranda Pothiawala. Earlier this year formal guidelines on how to maintain and update data submitted to the extended EudraVigilance Medicinal […]
By Guest Blogger | Published: April 14, 2014
By Peter O’ Donnell. The European Medicines Agency is determined to minimize opposition to its next moves on releasing clinical trial data. It announced last week yet another consultation on its plans to publish the results of trials — a policy it initially aimed at introducing from the beginning of this year. The latest twist […]
By Pharm Exec | Published: April 3, 2014
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.
By Guest Blogger | Published: March 25, 2014
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 […]
By Pharm Exec | Published: March 21, 2014
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Sylvant (siltuximab) for adult patients with multicentric Castleman’s disease.