MHRA and EMA divorce process continues ahead of Brexit deadline

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Evgeny Gromov)
(Image: Getty/Evgeny Gromov)

Related tags ABPI Mhra Ema

It has been revealed that the EMA is awarding significantly fewer contracts to evaluate the application of new drugs to the MHRA, as the Brexit deadline nears.

The deadline for Brexit is March 2019, which means that with only seven months left that the EMA could not risk drug evaluations potentially running over this deadline; in order to protect against this possibility, with most drug evaluations taking around a year, it will no longer award the MHRA with any new contracts.

The Guardian​ first reported that the European Medicines Agency (EMA) was limiting the number of contracts awarded to the UK’s Medicines Healthcare products Regulatory Agency (MHRA), after speaking to individuals from both organisations.

In the article, it noted that the MHRA had bid for a total of 36 EMA contracts in 2018 but had been awarded just two.

Existing contracts that the MHRA holds are now being transferred to other national regulatory agencies across Europe to prepare for the UK’s exit from the European Union (EU).

This transition will be particularly challenging for the EMA, given that the MHRA has always played a key role in evaluating medicines, taking on approximately 20% of all drug evaluations, according to the Association of the British Pharmaceutical Industry (ABPI).

In the media report, the ABPI suggested that the MHRA also carries out a third of all manufacturing inspections and identified the same proportion of drug safety signals on adverse events.

As a result of losing out on these contracts, the MHRA will lose out on funding worth £14m (€15.5m).

At least part of the responsibility that the MHRA developed was due to the presence of the EMA’s headquarters in London, but this will no longer be the case as of February 2019.

The EMA will move into temporary offices​ in February of next year while the Netherlands completes construction of the agency’s new headquarters.

Moving as a result of the Brexit referendum has hit the EMA particularly hard, with an announcement being issued out of the agency that it would have to reduce its activity due to a higher than expected number of staff losses​.

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