Get Multinational Clinical Trials In Europe And

EU-CTD obliges multiple safety submissions to NCAs and ECs, whereas EU-CTR requires all safety reporting via EudraVigilance. A single safety report can be submitted for trials involving more than one IMP, but all unexpected events which affect a trial's benefit-risk balance must be reported within 15 days.

The European Medicines Agency (EMA) is a decentralized agency of the EU responsible for the scientific evaluation, supervision, and safety monitoring of medicines. The EMA serves the EU and three countries from the EEA—Iceland, Norway, and Liechtenstein.

There are 50 countries in Europe, but only 44 of them have their capital city on the European continent. The largest country in Europe is Russia, followed by Ukraine and France. The smallest country in Europe is Vatican City, which is only about 0.44 square kilometers (0.17 square miles) in area.

The EUCTR replaces the previous European Clinical Trials Directive and governs the conduct of clinical trials in all EU Member States, including Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, ...

The United States is the clear frontrunner among the leading five countries for health-sciences research, with a Share almost four times higher than China, in second place. The United Kingdom is third, with a Share of almost 1,500, a higher placing than its fourth position overall in the Nature Index.

Information about the three EEA EFTA States: Iceland, Liechtenstein and Norway. The EU Member States, together with three of the EFTA States - Iceland, Liechtenstein and Norway - make up the EEA Contracting Parties (the EEA States).

All clinical trials, including phase 1 trials must first be registered in European EudraCT database after which the clinical trial application (CTA) is scrutinised by a Competent Health Authority and an Ethics Committee, in each country where the trial is intended to be conducted.

EU-CTD obliges multiple safety submissions to NCAs and ECs, whereas EU-CTR requires all safety reporting via EudraVigilance. A single safety report can be submitted for trials involving more than one IMP, but all unexpected events which affect a trial's benefit-risk balance must be reported within 15 days.