Brexit Impact: EMA Suspends Publication of Clinical Trial Data

Regulatory NewsRegulatory News | 15 August 2018 |  By 

As of 1 August, the European Medicines Agency (EMA) has suspended all new activities related to the publication of clinical data.

EMA said it will continue to publish clinical data submitted by the end of July but no new data packages will be processed until further notice.

“This is a result of the implementation of the third phase of EMA's business continuity plan to prepare for its relocation to the Netherlands,” the agency said.

EMA has stopped sending “invitation letters” and is contacting companies to cancel new submissions due after 1 August 2018. EMA will contact applicants prior to the restart of clinical data publication, once the relocation is complete, the agency added.

“By the end of October 2018, EMA will publish all clinical data submitted before 1 August 2018 (corresponding to regulatory procedures finalised in December 2016),” EMA noted.


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