Canada Develops RWE Guide Anticipating Increased Submissions
Executive Summary
New Canadian guidance is expected to help drug sponsors collect high-quality, real-world data that meets international evidence requirements for approval. It focuses on good practices for protocol development and data collection.
You may also be interested in...
Real-World Reluctance? Despite Guidance, Drug Developers Wary Of RWE-Based Trials
Biopharma companies are reluctant to rely on real-world evidence trials, but while uncertainty remains about how these novel studies will be accepted, US and other regulators are encouraging drug developers to take a chance – and some have taken on the challenge.
Canada To Open Up Priority Review To More New Drugs
Health Canada has proposed revised criteria that take account of patients' needs and the health care system when deciding whether to fast-track the review of a particular drug.
Centralized Templates To Help Harmonize Trial Dossiers Requirements Across The EU
Following feedback from its clinical trials expert group, the European Commission has published new and updated templates that sponsors can use to prepare study applications that would be acceptable in all the EU member states.