German Pilot Seeks Companies To Test EU's Future Clinical Trial Application Procedure
This article was originally published in SRA
Executive Summary
Drug regulators and research ethics committees in Germany have launched a pilot project to determine how they will meet the new rules and strict deadlines that the forthcoming EU Clinical Trials Regulation will introduce for processing clinical trial applications1.
You may also be interested in...
Belgium To Test Parallel Review Of Clinical Trial Dossiers Ahead Of New Regulation
Belgium is following the footsteps of Germany and France by launching a pilot to develop and test procedures for the coming EU Clinical Trial Regulation, which requires national competent authorities and ethics committees to evaluate trial dossiers in parallel and to issue a consolidated single decision within short timelines.
EMA Probe Finds No Link Between GLP-1s And Suicidal Thoughts & Actions
After reviewing the evidence from non-clinical studies, clinical trials, post-marketing surveillance data and other studies, the European Medicines Agency said there was no need to update the product information for 11 diabetes and weight management drugs.
English Funding For Aquipta Targets AbbVie’s Migraine Drug To 170,000 People
Aquipta is the first oral treatment that NICE has recommended for preventing chronic migraines in the fourth-line setting, and the second oral treatment for episodic migraines in the same setting. The drug has already secured reimbursement in Scotland, Sweden and Israel.