The Main Characteristics of Regulation (EU) 536/2014
- A single set of documents to be prepared and submitted for the clinical trial application (CTA).
- A streamlined application procedure via a single entry point, the EU portal.
- A harmonised procedure for the assessment of applications for clinical trials, which is divided in two parts. Part I is jointly assessed by all Member States concerned, which means the countries where the trial is intended to be conducted. Part II is assessed by each Member State concerned separately.
- The involvement of the Ethics Committees in the assessment procedure in accordance with the national law of the Member State concerned but within the overall timelines defined by the Regulation.
- Extension of agreement which will give sponsors increased legal certainty.
- Streamlined safety reporting procedures which will spare sponsors from submitting broadly identical information separately to various bodies and different Member States.
- Increased transparency as regards clinical trials and their outcomes.
- Union controls in Member States and third countries to ensure that clinical trials rules are being properly supervised and enforced.
- Clinical trials conducted outside the EU, but referred to in a clinical trial application within the EU, will have to comply with regulatory requirements that are at least equivalent to those applicable in the EU.