Belgium To Test Parallel Review Of Clinical Trial Dossiers Ahead Of New Regulation

Belgium is following the footsteps of Germany and France by launching a pilot to develop and test procedures for the coming EU Clinical Trial Regulation, which requires national competent authorities and ethics committees to evaluate trial dossiers in parallel and to issue a consolidated single decision within short timelines.

Belgium’s Federal Agency for Medicines and Health Products is preparing to launch a pilot later this year under which it plans to review clinical trial applications in parallel with national ethics committees and within the strict timeframes specified in the upcoming EU Clinical Trials Regulation.

The FAMHP explained that while the voluntary pilot would be conducted under Belgium’s current national clinical trials legislation of May 7, 2004, the evaluation of clinical trial dossiers included in the pilot “would follow the spirit” of the CTR that is set to come into force in October 2018. (Also see "Training For ‘Huge’ EU Clinical Trials Portal And Database On Track For 2017" - Pink Sheet, 6 Jan, 2017.)

Sponsors interested in participating in the pilot can still send in their proposals to [email protected] even though the official deadline for companies to sign up ended on Jan. 24, an FAMHP spokesperson told the Pink Sheet that. The selection of trials to be included in the pilot is to be confirmed by the FAMHP and the “college” of ethics committees that will be established in the future.

The selection of trials for the pilot will depend on the available capacity at both the FAMHP and the ethics committees and on the added value that such testing would bring. There is no restriction on the types of clinical trial applications that can be submitted under the pilot as it includes both national and multi-national trials as well trials evaluated under those voluntary harmonization procedures (VHPs) for which Belgium is the reference member state, the spokesperson clarified.

The response from sponsors to the pilot to date has been quite good with commercial as well as non-commercial sponsors submitting applications, the spokesperson said. The agency is aiming to evaluate a batch of 10 trials representing different types of applications.

The pilot is expected to help the FAMHP identify any potential obstacles involved with assessing applications under the CTR processes and timelines so that it can streamline its procedures before the new regulation enters into force. The first tests under the pilot are expected to begin in October/December 2017.

Germany and France have undertaken similar preparatory pilots to develop and test procedures in anticipation of the CTR. (Also see " German Pilot Seeks Companies To Test EU's Future Clinical Trial Application Procedure " - Pink Sheet, 29 Oct, 2015.) (Also see "French To Test Future EU Clinical Trial Procedures For Drugs" - Pink Sheet, 6 Oct, 2015.)

The Belgian pilot is expected to commence in March this year, when the government amends the existing 2004 clinical trials legislation to change, among other things, the provisions relating to ethics committees. Under the CTR, the review of clinical trial dossiers by the national competent authority and the ethics committee will have to run in parallel so that they are able to issue a consolidated single decision within a short timeline.

To ensure coordination between the FAMHP and the 24 accredited ethics committees currently functioning in Belgium, the government plans to establish a “college” of ethics committees in the near future. The college, which will be hosted by the Federal Public Service (Public Health), will be an independent entity and will act as a contact point between the FAMHP and the ethics committees.

The college will coordinate the working of the ethics committees and will be responsible for their quality assurance. The college will “support the ethics committees and attempt to harmonise their way of working,” the FAMHP spokesperson said.

In addition, to support the ethics committees, the government is developing a royal decree for the accreditation of ethics committees to enable them to evaluate clinical trials with medicinal products under the upcoming CTR, the spokesperson added.

From the editors of Scrip Regulatory Affairs.