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null Clinical Trials Regulation and CTIS to come into application 31 January 2022

Clinical Trials Regulation and CTIS to come into application 31 January 2022

2.8.2021

The EU Commission has confirmed that the Clinical Trials Regulation (CTR536/2014) will be applied simultaneously with the introduction of the Clinical Trials Information System (EUPD/CTIS) maintained by the European Medicines Agency on 31 January 2022.

In accordance with the Clinical Trials Regulation, the EU Commission published a notice in the Official Journal of the European Union (L275) on 31 July 2021 confirming the functionality of the key elements required for its implementation. The regulation shall enter into force and the CTIS will be introduced six months after the notification.

It aims to harmonise and streamline the submission, assessment and supervision processes for EU and EEA clinical trials. One common database reduces the administrative work of sponsors of clinical trials when the trial no longer needs to be notified to each national authority separately. The introduction of the system will also open up a public database where information can be obtained from all clinical trials in the EU.

EMA press release 02 August 2021:
Six-month countdown to go-live for the Clinical Trials Information System (CTIS)

More information for pharmaceutical industry operators on the introduction of the regulation and the CTIS on Fimea's website:
EU Regulation 536/2014
 

Ytterligare information ges av

  • clinicaltrials(at)fimea.fi
  • Marita Kailajärvi, Chief Physician, tel. + 358 29 522 3355
  • E-mail addresses are in the format firstname.lastname@fimea.fi