EMA Consults On Using Registry Studies As RWE Source
A draft EU guideline explains how disease registries can be used to supplement evidence in the pre-authorization phase and provide infrastructure for post-authorization evidence generation.
You may also be interested in...
The European Medicines Agency is planning an October workshop to discuss its new guideline on registry-based studies and to discuss recent experience on aspects such as the use of a large registry for clinical trials.
The UK Medicines and Healthcare products Regulatory Agency is developing a series of guidance documents on general points to consider when planning a trial to generate real-world evidence. The first document in this series focuses on prospective randomized trials.
With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.