The authorisation and oversight of clinical trials is the responsibility of EU/EEA Member States while EMA is responsible for maintaining CTIS. The European Commission oversees the implementation of ...

EU Clinical Trials Regulation (EU CTR) has been a hot topic for a little while now. An initiative launched by the European Commission, EMA, and national regulators within the EU in 2022 in order ...

A European Union (EU) ruling moving clinical trials across the continent onto a single platform, the Clinical Trials Information System (CTIS), has come into full effect with ‘corrective ...

A major overhaul and consolidation of EU clinical trial regulations is paving the way to faster approvals, greater international coordination, and resilience to drug shortages, according to ...

Bureaucracy and delays are pushing clinical trials away from Europe, with Asia and the United States taking the lead.

Members of the European Parliament has voted by a large majority to adopt the Clinical Trials Regulation ... effect in mid-2016 at the earliest. All EU member states will be obliged to adopt ...