Clinical Trial Regulation No. 536/2014 - implementation and changes

July 13, 2017

 

The Regulation 536/2014 will repeal Directive 2001/20/WE and comes into application in 2019. The change of law will require adjustments in documentation evaluation timelines and all procedures connected with this process.

The aim

Regulations' goal is to unify and harmonise the assessment and supervision processes for clinical trials throughout the European Union, via an EU portal and database. Portal will be mantained by EMA, Member States and European Commission. 

 

Regulation shall increase the efficiency of all trials in Europe because it will unify procedures for those conducted in multiple countries and the Regulation will help to avoid duplication of clinical trials or its repetition.

 

All clinical trials information will be stored in database and will ba available to the public access, unless exempted under the protection Regulation. 

 

Clinical Trial Application

All Member States will have to follow the same rules and time requirements when evaluating CTA.

CTA will be submitted by EU portal and sponsor shall propose one of the Member States concerned (MSC) as reporting Member State (RMS).

 

Part I

Application will be submitted in two parts, first will be evaluated by RMS within 10 days. RMS will notify sponsor whether the clinical trial applied for falls within the scope of regulation and whether the appplication is complete. The clinical trial shall be deemed to fall within the scope of Regulation and the application dossier shall be considered complete when the RMS has not notified sponsor within 10 days.


Reference Member State has 45 days after validation to evaluate the documentation and shall submit report of Part I assessment through the EU portal. Report shall include its conclusion, to the sponsor and to the other Member States concerned.

 

If clinical trial application involve more that one state the application will be evaluated by all of them in three stages. First of all the RMS will conduct an initial assessment, then coordinated review phase will be carried out by all Member States concerned and in the end a consolidation phase will be performed by the reporting Member State.

 

Part II

Application is going to be assessed by each Member State concerned for its own territory. Timelines for this assessement stay the same as for Part I of documentation evaluation. Notifications are submitted by EU portal along with roports.

 

Decision on the clinical trial

It is possible that not all states will report that the conduct of the clinical trial is acceptable or acceptable subject to compliance with specific condition.

 

When the reporting Member State conclusion is that the clinical trial is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned.

 

Public website

Detailed information on clinical trials can be accessed by public in all EU official languages:

  • overview of clinical trial statistics;

  • advanced search;

  • download data and reports;

  • site updates and announcements.
     

Implementation

As of July 13, 2017 the delivery time frame for the EU are considered on 2019.

 

More information can be found on EMA's website.

 

 

 

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July 13, 2017

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