Regulatory Information

ESMO's objective: allowing EU research to continue unhindered  

Clinical Trials Regulation

The Regulation came into effect in 2014 and acknowledges the importance of data stored for a clinical trial to be used beyond the end of a clinical trial, for research purposes, and ensures that medical research will be able to continue in a smooth manner. It will become law in all EU Member States six months after the European Medicines Agency has created the EU single portal and database and they are fully functional (but not earlier than two years after the regulation's publication, which means earliest in 2016).

Read the main points of the Clinical Trials Regulation

Data Protection Regulation

The ESMO position paper on the EU General Data Protection Regulation seeks to raise awareness with EU decision-makers that their legitimate response to citizens’ concerns on data security should not hinder the much-needed work of public health researchers and their appropriate access to data, acknowledging that strict safeguards protecting medical data are already in place.

Read the main points of the Data Protection Regulation