EMA says it’s busy with Brexit and needs specifics of EU pre-submission probe

By Gareth Macdonald contact

- Last updated on GMT

iStock/cbies
iStock/cbies
The EMA has asked the European Ombudsman for concrete details of its probe of pre-submission activities, warning that Brexit preparations have limited its capacity to respond.

Ombudsman Emily O’Reilly launched the investigation in July​ to determine if “eventual decisions by EMA on the authorisation of medicines may be influenced by what has been discussed during the meetings with medicine developers prior to receiving their marketing authorisation application​.”

O’Reilly asked for an overview of pre-submission activities between 2012 and 2016, including a list of the 10 medicine developers that met with the EMA most often. 

She also said “Even if EMA were to ensure that its subsequent assessments of applications for marketing authorisations are objective and complete, there is still a risk that pre-submission activities create, in the eyes of the public, at least some perception of bias​.”

The EMA responded in a letter​ published last week, describing the probe as “extremely broad-ranging​” because pre-submission activities cover more than just meetings and touch on all major operational processes at the agency.

Some of the questions you are raising may find an initial answer in the various documents already published on our external website. Some others would instead require a careful analysis as to their scope and purpose​” the agency said.

Huge Brexit disruptions

Such analysis is likely to be a challenging exercise according to the London-based agency, which said preparations for its relocation after the UK leaves the European Union (EU) are its focus for the next few years.

To be able to prepare for the move and work on necessary operational changes, we have already had to free up staff by reducing or temporarily suspending certain, less essential tasks.

It is obvious that we need to limit what we undertake and plan our activities with extreme care to ensure that the huge disruptions linked to Brexit, affecting both the agency as a whole and our staff individually, do not have an adverse impact on public health​.”

The EMA said it would meet with the Ombudsman this week to establish the scope of the investigation and agree a timeline.

Related topics: Regulatory & Safety, Regulations

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