[co-author: Elinor Pecsteen]

Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was adopted and entered into force in 2014. The European Medicines Agency (“EMA”) has recently confirmed that the Agency is currently on schedule to introduce the new related EU portal and EU database in October 2018. In light of this, the EMA plans to organise training sessions for users of the EU portal and EU database in the second half of 2017.

Background

Clinical trials in the EU are currently governed by Directive 2001/20/EC of 4 April 2001 relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (“Directive 2001/20/EC”). Directive 2001/20/EC will be replaced by the Clinical Trials Regulation following a three-year transitional period that is expected to end October 2021.

The current system provides that applicants for authorisation of a clinical trial must register the protocol for such clinical trial in the EudraCT database to obtain a EudraCT number. Applicants must then submit a related request to each EU Member State in which they wish to conduct the clinical trial. Following the approval of the clinical trial, the competent authority of the EU Member States in which the clinical trial is conducted must submit all information concerning the content, commencement and termination of a clinical trial to the EudraCT database.

In contrast to the current procedure, the EU portal required by the Clinical Trials Regulation will enable applicants who wish to conduct a multi-jurisdictional study in the EU to submit a single application dossier to the EU portal. The application dossier submitted via the EU portal will be accessible, through the EU database, to all EU Member States in which the applicant wishes to conduct the concerned clinical trial. This system intends to simplify and harmonise procedures for the authorisation, assessment and supervision of clinical trials.

The next steps for the development of the EU portal and EU database include the conduct of an independent audit and the publication by the European Commission of a notice once the EU portal and the EU database are proved to be fully functional. The Clinical Trials Regulation shall apply as from six months after the publication of this notice.

Implementation Timetable

On 17 December 2015, the EMA issued a “Delivery time frame for the EU portal and EU database”. This document provides an overview of the planned time frame for the development of the version of the EU portal and EU database which will be subject to an independent audit.

In the “Delivery time frame for the EU portal and EU database” document, the EMA planned for:

• the independent audit to run from August 2017 to November 2017;
• the European Commission notice to be published in the Official Journal of the European Union in March 2018;
• the EU portal and EU database to go-live in September 2018;
• and the new Clinical Trials Regulation to become applicable in October 2018.

On 2 December 2016, the EMA held the Annual European Medicines Agency Review of the Year and Outlook for 2017 conference (“the conference”). At the conference, the EMA stated that the first four of a number of User Acceptance Testing (“UAT”) exercises that are performed with each new version of the system have been completed on time.

The EMA confirmed that the Agency is so far respecting the timelines it has set itself in the “Delivery time frame for the EU portal and EU database” document and that the EMA is on track to launch the EU portal and the EU database in September 2018. This means that the Regulation shall, as foreseen, apply as from October 2018.

Training for use of the EU portal and EU database

At the conference, the EMA announced that sponsors of medicinal products and EU competent authorities will benefit from training to learn how to use the EU portal and EU database. Training sessions will be made available by the EMA during the second half of 2017 for the version of the system that has been built at that point. Further training will be made gradually available as additional functionalities are developed and added to the EU portal and EU database.

With the Clinical Trials Regulation, competent authorities of EU Member States and sponsors of clinical trials will have to submit information concerning the entire lifecycle of a clinical trial, from the preparation of an application to its submission, validation, authorisation and supervision. The EMA clarified at the conference that competent authorities and sponsors will be required to learn, i.e., how to register to use the system, manage their user access to a clinical trial and work in their designated workspaces using the new tools and capabilities.

This training will be made available to users online, through a number of modules focused on specific topics for training. The EMA also plans to organise face-to-face training days closer to the date of the launch of the EU portal and EU database in September 2018.

Current concerns and areas for improvement concern user management rules and how they will work in practice. The EMA intends for users of the system to have access to the EU portal and EU database functions according to their role, so the system will display the appropriate data and also the appropriate activities for them. UATs are currently being conducted to allow end-users to verify business functions and the system flow against business requirements.

Transitional period

The Clinical Trials Regulation foresees a transitional period of three years from the date of application of the Regulation. From October 2018 to October 2019, applicants may submit their clinical trial applications either under the new Clinical Trials Regulation using the EU portal and EU database, or under Directive 2001/20/EC using the EudraCT database. From October 2019 to October 2021, only clinical trials authorised under the Directive will continue to be governed by that Directive. Any trials authorised under the Directive and still on-going in October 2021 will from then-on be governed by the Clinical Trials Regulation.

For further information visit: https://pink.pharmamedtechbi.com/PS119781/Training-For-Huge-EU-Clinical-Trials-Portal-And-Database-On-Track-For-2017