EU directives/Regulations

Current status on EU legislation on clinical trials

A new regulation on clinical trial Regulation EU No 536/2014 is in the pipeline.

The main characteristics of the new Regulation will be:

  • “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. 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.
  • 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.”

Currently, Directive 2001/20/EC is in place until Regulation 2014/536/EU is implemented.

The implementation of the regulation is postponed until 2019.  Latest news on EU Clinical Trial Regulation from EMA here.

Medicinal Products for Human use legislation

Directives and regulations regarding clinical trials fall into EU pharmaceutical legislation. Information about legislation on medicinal products for human use can be found here.

Important legislation to keep in mind:

– Directive 2001/20/EC on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
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-Regulation EC No 1394/2007 on advanced therapies.
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– Regulation EU No 520/2012 on pharmacovigilance activities.
> Read more

-Regulation EU No 536/2014
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Information on Directives and Regulations regarding Technology Assessment and Health Informatics:

-On eHealth
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-On Health Technology Assessment
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-On data collection
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-On cross-border healthcare
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More information on Health at EU level here

EU directives/Regulations

Technology Assessment and Health Informatics

-On data collection:
Data protection is protected by the Directive 95/46/EC and Article 8 from Charter of Fundamental Rights of the European Union even if some Member State do not have explicit laws available.

Directive 2002/58/EC, directive on Privacy and Electronic Communications increase its relevancy in medical sector through the emergence of eHealth.

-On eHealth:
Despite increase in interest and use of eHealth nad in particular Telemedecine, no legal framework exists. Directive 2011/24/EU on cross-border healthcare provides regulation on reimbursement, international cooperation between healthcare entities and cross border enforcement of patients’ rights.

-On Health Technology Assessment:
Aim to provide policy-makers with evidence based information and can influence decision on reimbursement at national level. In 2016, the EU through the HTA network launched: EUnetHTA Joint Action 3.

EU directives/Regulations


The European commission defines telemedicine as ” the provision of healthcare services, through the use of ICT, in situations where the health professional and the patient (or two health professionals) are not in the same location. It involves secure transmission of medical data and information, through text, sound, images or other forms needed for the prevention, diagnosis, treatment and follow-up of patients”.

There is no regulation at EU level,, nevertheless some pre-existing directives influence it and give it a framework and guide Member States: Directive 2011/24/EU, Directive 95/46/EU, Directive 2000/31/EC and Directive 2002/58/EC.

More information on Telemedicine here.

More information on eHealth in general here.


-Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare
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-Directive 95/46/EU on the protection of personal data
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-Directive 2000/31/EC on ‘electronic commerce’
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-Directive 2002/58/EC on privacy and electronic communications
> Read more