FAQ - Frequently Asked Questions
To what extent is there an obligation for those responsible for clinical trials to publish their results in the European EudraCT database?
Transparency in clinical trials is indispensable to protect health and foster innovations in medical science. The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, expressly supports the joint request by the European Commission (EC), The European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) to the persons responsible for clinical trials to provide the results of their authorised clinical trials in the European database, EudraCT.
There is currently no general legal obligation to publish reports on the results of clinical trials. Other than in the case of a European Directive, the Guideline of The European Commission 2012/C 303/03 – Guidance on posting and publication of result-related information on clinical trials does not represent a binding legal basis.
However, with regards to an obligation in the meaning of a legal obligation for the sponsors of a clinical trial and the authorisation holders to transmit the reports on the result of clinical trials to the EMA – also for the inclusion in the EurdraCT database – such a binding legal basis would be required.
Such a binding legal basis is included in the so-called Paediatric Regulation (Regulation (EC) No 1901/2006). Pursuant to Article 41 of this regulation in connection with the (not legally binding) guideline of the European Commission – Guidance on posting and publication of result-related information on clinical trials as part of the implementation of Article 57 para 2 of Regulation (EC) No 726/2004 and Article 41 para 2 of Regulation (EC) No 1901/2006 (2012/C 302/03) – results of clinical trials must be uploaded to the EudraCT database in accordance with Articles 45 and 46 of Regulation 1901/2006. Parties obliged to fulfil this obligation (only) include the sponsors/marketing authorisation holders of paediatric clinical trials in the context of the Paediatric Regulation, or similar parties.
It can be assumed that universities adhere to the usual scientific practice of publishing results such as publications in scientific journals. Capturing the results of clinical trials in EudraCT contributes to additional transparency.
In future, the results of all clinical trials conducted in the EU will be accessible to the public through an EU database. For this purpose, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (2014) lays down requirements for the publication from clinical trial data throughout Europe. However, Regulation (EU) No 536/2014 can only be implemented when the EU portal (among other things designed as the successor of EudraCT) is in operation at the European Medicines Agency (EMA), which is so far not the case.
What are the legal options to increase the number of publications of results of authorised clinical trials according to Regulation (EU) No. 536/2014?
Although regulation (EU) No 536/2014 was adopted in 2014, this regulation is not yet in force, since the portal and the database do not yet exist. Since Regulation (EU) No 536/2014 cannot be applied directly to clinical trials already started pursuant to Directive 2001/20 EC, i.e. its translation into the German Medicines Act (Arzneimittelgesetz) and the GCP Regulation, it is currently not possible to impose penalties in retrospect. As mentioned in Answer 1, this would require a legal basis.
For further questions on the timelines of the implementation of the regulation please contact DG Sante at the EU Commission or the European Medicines Agency (EMA), which is responsible for the regulation’s implementation.