From the end of 2021 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 2021.
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.
Until the end of 2019, the FOPH had been monitoring developments on a permanent basis, and has had 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 has been using 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.
- Executive summary-implications for Switzerland of Regulation (EU) on Clinical Trials on Medicinal Products (PDF, 156 kB, 28.02.2019)
- Schlussbericht: Auswirkungen der VO 536/2014 über klinische Prüfungen mit Humanarzneimitteln (only in German) (PDF, 1 MB, 26.03.2019)
- Report by C.A. Zenger (only in German) (PDF, 922 kB, 28.11.2016)Comparison between the Swiss federal human research act and implementing ordinances and the EU regulation of 16 April 2014 (CTR) on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
- Table comparing Clinical Trials Ordinance (ClinO) and CTR (only in German) (PDF, 722 kB, 28.11.2016)
- Addendum - EU regulation, December 2019 update (PDF, 127 kB, 28.02.2020)
- EU regulation, December 2019 update (PDF, 415 kB, 20.12.2019)
- EU Regulation, August 2019 update (PDF, 336 kB, 13.08.2019)
- EU regulation, April 2019 update (PDF, 304 kB, 25.04.2019)
- EU regulation, December 2018 update (PDF, 248 kB, 20.12.2018)
- EU regulation, August 2018 update (PDF, 281 kB, 31.08.2018)
Last modification 19.11.2020