Clinical trial regulation in Europe - Legal reporting requirements and regulatory strategies in seven key countries “We advocate full transparency of which clinical trials are ongoing

Article 44 of the Law of 7 May 2017 provides for the following penalties (for your information: article 37 of the Regulation 536/2014 provides for the obligation to publish the results of a clinical trial within one year after the end of the trial): • Article 44. [...] The civil servant-lawyer, can either send the original of the report directly to the Public Prosecutor, or propose a settlement to the offender, within three months of the date of the report. [...] If the civil servant-lawyer does not propose a transaction to the offender, they will send the original of the report to the Public Prosecutor for the prosecution of the public action. [...] Based on the original estimated duration of the trial, which was initially informed by the sponsor upon the authorization of the trial, Fimea actively contacts the sponsor in case the information of the date of completion and/or the results of the trial have not been forwarded to Fimea. [...] Based on the original estimated duration of the trial, which was initially informed by the sponsor upon the authorization of the trial, Fimea actively contacts the sponsor in case the information of the date of completion and/or the results of the trial have not been forwarded to Fimea.