Applying Regulation (EU) no. 536/2014 in Clinical Trials

by Vittoria de Giovanni di S Severina, Associate Partner-Quality Assurance Specialist - GCP & GCP Auditor @ PQE Group

Where we are now

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31 January 2022 represented the GO LIVE date of the new Clinical Trials evaluation system in Europe, with the full application of Regulation (EU) no. 536/2014: THE NEW CLINICAL TRIAL REGULATION! 

From that date, a one-year transition period began. During this period, applications for authorization of clinical trials pursuant to Directive 2001/20/EC (LINK) were allowed on a voluntary basis.  

Beginning 31 January 2023, all initial clinical trial applications in the EU must be submitted via the Clinical Trials Information System (CTIS). Within the next two years all ongoing trials will transition to the new requirements under the EU Clinical Trial Regulation (CTR). 

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CTR Main Goals

The goal of the CTR is to create an environment favorable to conducting clinical trials in the EU by harmonizing the assessment and supervision rules and processes of clinical trials, while guaranteeing the highest standards of safety for participants and the transparency of information through the publication of all information concerning the authorization, conduct and results of each clinical trial carried out in Europe. 

What does CTR replace? 

The new Clinical Trials legislation has taken the legal form of a Regulation, thus replacing Directive 20/2001/EC and national law. This will ensure that the rules for assessing clinical trial applications and for conducting clinical trials are identical throughout the EU.

Key Features and Application 

The main characteristics of the new CTR are:





New clinical trial application 

A streamlined application procedure via a single entry point - an EU portal and database, for all clinical trials conducted in EEA. Registration via the portal will be a prerequisite for the assessment of any application 

CTA Dossier 

A single set of documents to be prepared and submitted for the application.  


Authorization procedure 


A single authorization procedure for all clinical trials, allowing a faster and more thorough assessment of an application by all Member States concerned, coordinated by the Reporting Member State (RMS) and ensuring one single assessment outcome and authorization per Member State.  


A harmonized 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. 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. 


Authorization timelines 

Strictly defined deadlines for the assessment of clinical trial application. 






EU Database 

As soon as the decision on a clinical trial is made, all information submitted through the EU portal is then stored in the EU Database. 

Access to DB 

Publicly accessible unless, for all or part of the data and information contained therein, confidentiality is justified. 


Database access for citizens of the Union to clinical information about medicinal products. 

Clinical trial summary of results  

The sponsor should submit a summary of the results of the clinical trial together with a summary that is understandable to a layperson. 

Coordination and advisory committee (CTCG) 

This committee serves as a forum for exchanging best practices between Member States. 


Communications between stakeholders 

Trial related communication between sponsor and RMS and MSC entirely through EU portal. 


Union controls in Member States and third countries to ensure that clinical trials rules are being properly supervised and enforced. 




Safety reporting 

Simplified reporting procedures which will spare sponsors from submitting broadly identical information separately to various bodies and different Member States.  


Vulnerable populations 

Specific considerations will be given in the assessment of CTAs addressing vulnerable populations (minors, incapacitated subjects, pregnant or breastfeeding women). 

Damage compensation 

Risk-based damage compensation will be available to patients participating in clinical trials. 


Clinical trials in emergency situations 

CTR outlines specific cases where informed consent may be obtained, and information on the clinical trial may be given, after the decision to include the subject in the clinical trial. 

Cluster trials 

Specific trials where the investigator may obtain informed consent by simplified means. 


EMA’s training resources are tailored for clinical trial sponsors and staff of the European Union (EU) Member States, European Commission and other organizations who will use the system. 

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This system includes three main components that fulfil the needs of its different users: 

  • Authority workspace 
  • Public website 
  • Sponsor workspace 

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In conclusion, the regulation aims to simplify and accelerate procedures authorizing clinical trials to ensure that the European Union (EU) remains attractive for stakeholders conducting clinical research. 


Are you ready?

The Quality Management system of involved stakeholders (pharmaceutical companies, CROs and investigational sites) must be compliant with all new requirements introduced with this regulation. PQE services are able to support them by ensuring the implementation of Standard Operating Procedures with required control measures and quality checks during the involved clinical processes. 


Want to know more?

PQE Group can support your business in reaching the compliance for your products as well as in implementing new procedures, tools and software.

To get more information or support, get in touch with us  or check our Quality Compliance dedicate page to find the most suitable solution for your company.

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