EU clinical trial harmonisation pilot expands scope
This article was originally published in Scrip
Companies planning to undertake multinational clinical trials in just three or more European Union member states are now eligible to participate in the voluntary harmonisation procedure, the pilot programme initiated by the Heads of Medicines Agencies Clinical Trials Facilitation Group that offers co-ordinated and simultaneous review of clinical trial applications.
You may also be interested in...
The Netherlands-based GetReal Institute builds on seven years of multi-stakeholder collaboration to promote greater understanding of real-world evidence.
With the COVID-19 pandemic exacerbating the challenges of recruiting patients for studies targeting catastrophic diseases and rare cancers, regulators are becoming more receptive to new ways of using real-world evidence in clinical trials.
Companies can get the European Medicines Agency’s scientific opinion for their products’ use in EU and non-EU countries at about the same time.