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High safety standards and streamlined procedures for EU clinical trials

High safety standards and streamlined procedures for EU clinical trials

 

SUMMARY OF:

Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use

WHAT IS THE AIM OF THE REGULATION?

  • The regulation aims to ensure the safety of those participating in clinical trials. It also aims to simplify and speed up procedures authorising these trials which are vital for developing new medicines and improving treatments using existing medicines.
  • It repeals Directive 2001/20, which is still in force (see section "From when does the regulation apply?" below).

KEY POINTS

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.

Rules

  • 1.

    Less bureaucracy (‘red tape’): 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.

    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.

FROM WHEN DOES THE REGULATION APPLY?

Regulation (EU) No 536/2014 shall apply as from six months after the publication of the notice referred to in Article 82(3) stating that an independent audit report verified that the EU portal and the EU database have achieved full functionality. The existing legislation in the field (Directive 2001/20/EC) will be repealed following a three year transition period from that date.

BACKGROUND

For more information, see:

MAIN DOCUMENT

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 (OJ L 158, 27.5.2014, pp. 1-76)

Successive amendments to Regulation (EU) No 536/2014 have been incorporated into the original text. This consolidated version is of documentary value only.

RELATED DOCUMENTS

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. 34-44)

See consolidated version.

last update 07.05.2020

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