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Document 32014R0536

High safety standards and streamlined procedures for EU clinical trials

High safety standards and streamlined procedures for EU clinical trials

The European Union (EU) has adopted a law that, from 2016, should ensure the safety of those participating in clinical trials. The law also aims to simplify and speed up procedures authorising these trials which are vital for developing new medicines and improving treatments using existing medicines.


Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.


General principle: a clinical trial may be held only if:

  • the rights, safety, dignity and well-being of participants are protected and prevail over all other interests; and
  • it is designed to generate reliable and robust data.


  • 1.

    Less bureaucracy: sponsors of clinical trials will only need to submit a single application for approval irrespective of where in the EU the trial is to be held. There will be less red tape for less risky trials.

  • 2.

    Shorter authorisation times: the timeline to authorise clinical trials is set at 60 days. If no decision is taken within this period, the trial may go ahead (‘tacit approval’). Decisions on applications for substantial modifications of clinical trials must be taken within 49 days. Where no decision is issued, the authorisation is considered to be given.

  • 3.

    Vulnerable groups: applications for the authorisation of clinical trials must be assessed on the basis of appropriate expertise. Specific expertise must be used to assess clinical trials involving participants in emergency situations, minors, those who are incapacitated, pregnant and breast-feeding women and, where appropriate, certain other groups, such as older people or those suffering from rare and extremely rare diseases.

  • 4.

    Ethical review: all trials are subject to scientific and ethical review. The ethical review must be performed by an ethics committee in accordance with the law of the EU country concerned. However, the procedures and the timelines for the ethical review must be compatible with the authorisation procedure stipulated by this regulation.

  • 5.

    5. Informed consent: prior to the trial, participants must be given clear information about their rights (including the right to withdraw); conditions, duration, nature, objectives, implications, risks and inconveniences of the trial; possible treatment alternatives; and the possible damage compensation system.

  • 6.

    Publicly accessible EU database on clinical trials: the European Medicines Agency will set up a database containing information on all clinical trials held in the EU, whether successful or not.


Regulation (EU) No 536/2014 takes effect on 28 May 2016. The existing legislation in the field (Directive 2001/20/EC) is repealed from that date.


Although Europe’s pharmaceutical sector is highly innovative, fewer clinical trials have been held in the EU in recent years. This is in part due to differing interpretations across EU countries of the existing law on clinical trials which made running trials in more than one EU country difficult and expensive.



Entry into force

Deadline for transposition in the Member States

Official Journal

Regulation (EU) No 536/2014

16.6.2014 Application not earlier than 28.5.2016


OJ L 158 of 27.5.2014


Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).

last update 10.08.2014