EMA updates management board on Brexit and EU clinical trial portal

During the 100th meeting of the European Medicines Agency’s (EMA) management board, the agency provided updates on its preparations for Brexit and stated that the European Union (EU) clinical trial portal is “nearing completion”.

The EMA and the Netherlands have signed the agreement which details the legal relationship between the agency, its staff and the Dutch Government once the agency begins operations in the Netherlands next year. The EMA stated that the agreement provides assurance that EMA staff members and their families who are having to relocate early to the Netherlands can do so under the protection of the Seat Agreement.

The EMA has also redistributed the 370 centrally authorised products with United Kingdom (UK) rapporteurs to new co-rapporteurs from other EU countries as well as Iceland and Norway. Marketing authorisation holders were notified of the new rapporteurships in April and the new co-rapporteurs will assume full responsibility for the reallocated products on 30th March 2019, when the UK exits the EU. In the meeting the agency announced that they are working on a “knowledge transfer package” for each reallocated product that will include background information on the regulatory and evaluation history of each product. The aim of the packages are to help national regulators allocate resources for the new products added to their portfolios, especially for complex products.

The EMA also told its management board that development of the auditable release of the EU clinical trial portal and database is nearing completion; the release is now in an intensive phase of testing. In June 2017, the EMA delayed the application of the EU Clinical Trial Regulation from October 2018 to 2019 due to technical difficulties with the development of the IT systems, which included the portal and database for all clinical trials in the EU.

In the meeting the EMA stated that user acceptance testing of the release of the EU clinical trial portal will begin in November 2018, after the relocated data centre is complete, and the agency is planning to audit the system in early 2019. The EMA plans to pay close attention to how its relocation may impact the completion of the clinical trial portal, especially if key agency or developer staff choose not to relocate.

To read more on the highlights of the June 2018 EMA management board meeting, please click here.