In 2017 the landmark mutual recognition agreement between the EU and the US on pharmaceutical inspections finally became operational. The European Commission published its long-awaited report on ten years of the EU Paediatric Regulation, but the implementation date of the new EU Clinical Trials Regulation was put back yet again. PRIME, the European Medicines Agency’s priority medicines scheme for speeding up access to medicines for unmet medical needs, is now well and truly a fixture on the EU regulatory scene.
The EMA’s policy on the proactive publication of clinical data passed its one-year anniversary, and patient involvement in the medicines...
