Update on the EU Clinical Trial Regulation 536/2014 at the 97th EMA Management Board 5th October 2017

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Update on the EU Clinical Trial Regulation 536/2014 at the 97th EMA Management Board 5th October 2017

The EMA Management Board was updated last Friday, 5th October 2017, on the EU Clinical Trial Regulation 536/2014, especially on the development of the clinical trial EU Portal and EU Database.

The development is progressing, though still requires close monitoring. More precision of the delivery timeframe will be possible after a planned cycle of extensive testing by Member States and sponsor representatives, and, when further progress with the auditable version of the system has been made. The development remains aligned to the schedule that enables the EU Clinical Trial Regulation to come into application in the second half of 2019.The previous schedule was for the Regulation to become applicable in October 2018, so it seems the delay will be at least 9 months, possibly a year.

The Delivery time frame for the EU portal and EU database that was endorsed in 2015 will be revised when more is known about the first activity (“Auditable Version released for audit, including implementation of auditable and non-auditable must requirements”). The development of the EU portal and EU database was delayed due to technical difficulties with the development of the IT systems.

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/12/WC500199078.pdf

Brexit preparations, Report from the Committee for Orphan Medicinal Products (COMP) & Mid-year report were also discussed at the Meeting.

http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2017/10/WC500236190.pdf

As a reminder, although the Regulation was adopted and entered into force in 2014, the timing of its application depends on confirmation of full functionality of the EU portal and EU database through an independent audit. The Regulation becomes applicable six months after the European Commission publishes notice of this confirmation.

Pierre Mermet-Bouvier

Author

Pierre Mermet-Bouvier, Global Head of the Project Management Office at Clintec

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