Review of EU clinical trials framework on track; directive to be replaced with regulation
This article was originally published in SRA
Executive Summary
The European Commission wants to replace the EU directive on clinical trials – which is currently undergoing revision – with a regulation so as to ensure greater uniformity among member states in implementing the revised provisions, EU commissioner for health and consumer policy John Dalli announced at a 7 March meeting1.
You may also be interested in...
Global Medtech Guidance Tracker: February 2021
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-eight guidance documents have been posted on the tracker since its last update.
First Oral Treatment For Spinal Muscular Atrophy Gets EMA Nod
New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
EMA Works On Defining Metadata From RWD Sources
As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: