Clinical Trials Regulation 536/2014
The European Clinical Trials framework will undergo a major change when the Clinical Trials Regulation 536/2014 comes into application towards the end of January 2022.
The European Clinical Trials framework will undergo a major change when the Clinical Trials Regulation 536/2014 comes into application towards the end of January 2022. The legislation becomes a regulation, rather than a directive, which will ensure key aspects have identical rules throughout the EU.
The main characteristics of the new Regulation are:
In order to meet the essential elements for successful implementation of the Regulation and reaching its objectives, EFPIA has identified three key and distinct needs as follows:
The main characteristics of the new Regulation are:
- A streamlined application procedure via a single entry point, the EU portal.
- A single set of documents to be prepared and submitted for the clinical trial application (CTA).
- 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.
- A harmonised procedure for the assessment of clinical trials application.
- 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 the tacit agreement principle to the authorisation process which, without compromising safety, 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.
In order to meet the essential elements for successful implementation of the Regulation and reaching its objectives, EFPIA has identified three key and distinct needs as follows:
- Deliver flexible, efficient and streamlined execution of the authorisation procedure to avoid administrative delays.
- Enable the required collaboration between concerned Member States, as well as sponsors
- Appropriately manage the transparency of data over the life of the clinical trial.