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French ePharmaDay 2015: New EU Clinical Trial Regulation and Data Transparency

Posted on November 24th, 2015 by in Pharmacovigilance


On 16 April 2014, the new EU Clinical Trial Regulation on medicines for human use was adopted. The purpose of the new Clinical Trial Regulation is to create an environment that is favourable for conducting clinical trials, with the highest standards for patient safety, within the EU.

The main characteristics of the EU Clinical Trial 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 application, defined in Annex I of the Regulation;
  • 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 and Part II is assessed by each Member State concerned separately;
  • Strictly defined deadlines for the assessment of clinical trial 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 whole authorisation process which,¬†without compromising safety,¬†will give sponsors, in particular SMEs and academics,¬†increased legal certainty;
  • Simplified 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; and
  • 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.

Reporting Safety information from Clinical Trials

The Clinical Trial Regulation simplifies the rules on safety reporting:

  • The protocol may provide that not all adverse events (AE) and serious adverse events are recorded and reported;
  • For a clinical trial involving more than one investigational medicinal product (IMP) there is the possibility to submit in the Clinical Trial Eudravigilance database a single safety report on all IMPs used in that clinical trial; and
  • Suspected unexpected serious adverse reactions (SUSARs) will be reported via the Clinical Trial¬†Eudravigilance database.


The Clinical Trial Regulation provides more transparency on the clinical trials data.

All information in the EU database submitted in the clinical trials application and during the assessment procedure shall be, in principle, publically accessible unless the confidentiality of the information can be justified on the basis of any of the below listed grounds:

  • Protection of commercially confidential information;
  • Protection of personal data;
  • Protection of confidential communication between the Member States in relation to the preparation of the assessment report; or
  • Ensuring effective supervision of the conduct of clinical trial by Member States.

Additionally, the Regulation obliges the sponsor to submit to the Database a summary of results and a lay person summary one year after the end of the trial in the EU. A Clinical Summary Report should be submitted to the database 30 days after a Member state grants a Marketing authorisation for the investigational medicinal product, the procedure for granting the marketing authorisation has been completed or the applicant for marketing authorisation has withdrawn the application.

Making Research Data Available

Clinical trials are essential in drug development and are the cornerstone for getting a medicinal product authorized for marketing, because clinical trials investigate efficacy and drug safety. When the results of clinical trials are published, they can be informative to health care professionals, policy makers, media and the general public. But not all trial results are conclusive or significant, and many trials show that drugs are ineffective.

Do you want to know what happens to these results? Join the presentation about Elsevier‚Äôs newly launched Open Access Journal ‚ÄėContemporary Clinical Trials Communications‚Äô at the French ePharma Day 2015 to find out.

See also: French ePharma Day programme

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