How are clinical trials in Europe governed?

Clinical Trials Directive is soon to be replaced by the Clinical Trials Regulation
Clinical Trials Directive is soon to be replaced by the Clinical Trials Regulation © Andres Rueda

SciTech Europa Quarterly takes a look at the regulatory framework governing clinical trials in Europe.

The high standards of quality and safety of medicinal products in the EU are guaranteed by the legal framework in place across the Union. This regulatory environment (soon to be governed by the Clinical Trials Regulation) also promotes the functioning of the internal market, encouraging innovation and competiveness in Europe through various measures.

This framework is based on the principle that medicinal products may be placed on the market only following a marketing authorisation granted by the competent authorities, and in order to achieve this a large body of legislation has developed with the progressive harmonisation of requirements implemented across the whole European Economic Area (EEA).

The safety and effectiveness of investigational medicinal products (IMPs) are established or confirmed by scientifically controlled studies known as clinical trials. In the European Union, the conduct of these trials is currently governed by the Clinical Trials Directive. However, this is soon to be replaced by the Clinical Trials Regulation, which, according to the European Commission, aims to ensure ‘a greater level of harmonisation of the rules of conducting clinical trials throughout the EU.’

The Clinical Trials Regulation will include:

  • Strengthened transparency for clinical trials data;
  • A single authorisation procedure for all clinical trials, to allow a faster and more thorough assessment by all concerned EU countries;
  • A streamlined application procedure for all clinical trials conducted in Europe via a single EU portal and database; and
  • The extension of the silent agreement principle to the authorisation process giving more legal certainty to sponsors and researchers, in particular SMEs and academics

How will the Clinical Trials Regulation help?

For the European Medicines Agency (EMA), which bases its opinions on the authorisation of medicines on the results of clinical trials carried out by pharmaceutical companies, the new Regulation will enable an environment favourable to conducting clinical trials in the EU, ‘with the highest standards of safety for participants and increased transparency of trial information.’

The EMA also argues that the Clinical Trials Regulation will increase the efficiency of all trials in Europe with the greatest benefit for those conducted in multiple member states.

It also aims to foster innovation and research, while helping avoid unnecessary duplication of clinical trials or repetition of unsuccessful trials.

Some 4,000 clinical trials are authorised in the European Economic Area (EEA) annually, which are a result of around 8,000 clinical-trial applications, each involving two member states on average. The EMA also reveals that approximately 61% of clinical trials are sponsored by the pharmaceutical industry and 39% by non-commercial sponsors, mainly academia.

Is the Clinical Trials Regulation going to be delivered on time?

While EMA’s management board endorsed a delivery timeframe for the new regulation in December 2015, technical difficulties with the development of the IT systems have resulted in the date for the portal – which will be the single entry point for submitting clinical trial information in the EU, which will then be stored in the database – to go live being postponed, meaning that the EU Clinical Trial Regulation will now come into force during 2019 rather than in October 2018, as previously scheduled.


This article will appear in SciTech Europa Quarterly issue 26, which will be published in March, 2018.

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