Clinical trials on medicinal products for human use in the EU

From the end of 2020 there will be new regulations in place in the EU governing clinical trials on medicinal products. These rules will affect clinical trials in Switzerland. The FOPH is assessing the impact and closely monitoring further developments.  

Implications for Switzerland of the EU Regulation on Clinical Trials on Medicinal Products for Human Use

Following the jurisprudential comparison between the EU Regulation and the current Swiss legislation on human research (see below), the FOPH had commissioned a multidisciplinary study to investigate the possible implications for Switzerland of the EU Regulation following its implementation. The economic relevance of drug research first had to be established so that the possible legal challenges could then be highlighted – for example, the need to ascertain the views of stakeholders and their expectations regarding the legislation. The study was conducted by a consortium headed by Prof. Michael Hahn from the Institute of European and International Economic Law at the University of Bern (IEW).

A comparison of EU and Swiss legislation

On behalf of the FOPH, Christoph A. Zenger compared the federal legislation on human research in Switzerland and the new EU regulation on clinical trials on medicinal products for human use. The report was published in the Jusletter legal newsletter on 17 November 2014.
On 16 April 2014 the European Parliament passed the definitive version of of the new EU regulation on clinical trials on medicinal products for human use. Almost simultaneously, on 1 January 2014, the Human Research Act and the accompanying ordinances entered into force in Switzerland. In his analysis Christoph Zenger demonstrates that the EU and Swiss regulations are not always compatible.

Status of implementation in the EU

In the future, clinical trials in the European Union (EU) will be subject to uniform rules set down in Regulation EU No 536/2014 on clinical trials on medicinal products for human use (Clinical Trials Regulation or CTR for short). The CTR will harmonise the approval process across the EU.

Under the old regulations the sponsor had to submit separate applications for a multinational study to the authorities and ethics committees of each of the EU member states involved, in the language of the state in question and, depending on the state, accompanied by additional documentation. In the future a single, central application will be sufficient for the whole EU, which can be submitted by the sponsor via an online portal at the European Medicines Agency (EMA).

The new rules will apply as soon as the planned online portal is up and running, probably at the end of 2020.

The implementation work initiated since the CTR was passed includes the following:

  • Online portal set up and developed by the EMA (in collaboration with EU member states and the European Commission).
  • Delegated and implementing acts formulated by the European Commission.
  • Enactment of national laws governing aspects that the CTR leaves to legislators in EU member states.

The FOPH is monitoring developments on a permanent basis, and has commissioned SFL to report regularly on the setting up and development of the online portal and the planned delegated acts, implementing acts and memoranda. SFL uses the following sources:

  • Communications from the European Commission and EMA
  • Contacts with decision makers connected with the European Commission and EMA

The reports are published in English and can be accessed under Documents.

Last modification 22.10.2019

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Federal Office of Public Health FOPH
Division of Biomedicine
Human Research Section
Schwarzenburgstrasse 157
3003 Berne
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