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Clinical trials

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Clinical trials

 

Clinical trials assess the effectiveness and safety of medications or medical devices by checking their effects on humans.

 

In general, new medicinal products in Europe have to pass through the following steps:

Graphic Clinical Trials.PNG

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All clinical trials carried out in the EU have to be performed in accordance with the Clinical Trials Directive 2001/20/EC and the ethic principles of the Helsinki Declaration.

In October 2018, the new Clinical Trials Regulation EU No 536/2014  (EU-CTR) becomes applicable and will replace Directive no 2001/20/EC (EU portal and EU database delivery time frame).

Main characteristics of the new regulation:

  • Registration via a single EU entry portal for all clinical trials conducted in Europe,
  • Harmonized authorisation procedure with a single set of documents and a central database for all clinical trials,
  • Authorisation procedures carried out by National Competent Authorities in the Member States according to common protocols.


The following flowchart provides a first insight into the authorisation procedure under EU-CTR.

To obtain an overview of National Competent Authorities for Clinical Trials, please consult the EudraCT, the EU clinical trials database for clinical trials on medicines which commenced in the Community from 1 May 2004.

The EU Clinical Trials Register, launched by EMA in March 2011, allows public access and search for information on completed and ongoing clinical trials for medicines. The information is extracted from EudraCT.

Clinical trial sponsors have to consider a dual submission procedure. The documents have to be submitted to

1) the National Competent Authority, and ICH-GCP serves as the basis for an adequate documentation:

ICH (International Conference on Harmonisation = international bodies from America, Europe and Japan) - GCP (Good Clinical Practice) represents an international quality standard for a set of criteria such as conduct, monitoring, auditing and reporting of clinical trials. It ensures that the data and the results are reliable and accurate, and that confidentiality and rights of subjects and volunteers are protected.

In parallel, documents have to be submitted to

2) the relevant Ethics Committee for evaluation. An overview which Ethics Committee needs to be contacted in the different Member States is provided by the European Network of Research Ethics Committees.

It is recommended to authorize a Contract Research Organization (CRO) with the professional management of the complete clinical trials procedure. A CRO provides full support in pre-clinical and clinical trials management and pharmacovigilance by offering to their clients the expert knowledge of transferring a new pharmaceutical or device from its concept to market approval.

For further particulars, please view the survey Entry Portal Contract Research Organisations in Europe.

 

Ecosystem of Nanomedicine:

EU Regulatory Process  >> International Regulatory Processes >> Clinical trials >>  Pricing and Reimbursement


Contact:

Should you have any question or require further information related to the ecosystem of Nanomedicine, please contact:

Dr. Klaus-Michael Weltring
Gesellschaft für Bioanalytik Münster e. V.
Tel. +49 (0)251 38450333
weltring@bioanalytik-muenster.de