EMA Updates Management Board on Brexit, Clinical Trial Portal

Regulatory NewsRegulatory News | 08 June 2018 |  By 

During the 100th meeting of the European Medicines Agency's (EMA) management board this week, the agency provided updates on its preparations for Brexit and said that the EU clinical trial portal is "nearing completion."

Brexit Updates

At the meeting EMA announced that it and the Netherlands have signed the agreement detailing the legal relationship between the agency and its staff, and the Dutch government once the agency begins operations in the Netherlands next year.

"The agreement will provide assurance that EMA staff members and their families who need to relocate early to the Netherlands can do so under the protection of the Seat Agreement immediately," EMA said.

The agency also said it has redistributed the 370 centrally authorized products with UK rapporteurs to new co-rapporteurs from other EU countries as well as Iceland and Norway.

According to EMA, 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 30 March 2019, when the UK officially exits the EU.

The agency is also 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 packages are intended to help national regulators allocate resources for the new products added to their portfolios, especially for more complex products.

Clinical Trial Portal

EMA also told its management board that an auditable release of its EU clinical trial portal and database is nearly complete.

"Development of the auditable release of the portal and database is nearing completion. The release is now in an intensive phase of testing," the agency said.

In June 2017, EMA delayed application of the EU Clinical Trail Regulation from October 2018 to 2019 due to technical difficulties with the development of the IT systems necessary to implement the regulation, which include an auditable portal and database for all clinical trials in the EU.

Looking ahead, EMA said it will begin user acceptance testing of the release in November after the relocated data center is completed, and is planning to audit the system in early 2019.

EMA also said it is paying close attention to how its relocation may impact the completion of the clinical trial portal, especially in the event key agency or developer staff choose not to relocate.



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