Ombudsman disagrees with EMA clinical trial data disclosure policy
This article was originally published in SRA
The European Ombudsman has criticised the European Medicines Agency for turning down requests for access to certain clinical trial data on two anti-obesity drugs – orlistat and rimonabant – on the grounds of protecting drug company commercial interests1,2.
You may also be interested in...
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.
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.
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.