EMA’s Brexit relocation decision date announced

The European Medicines Agency has given an update on its preparations for Brexit, ahead of the October meeting that will decide its new location.

In its latest management board update the EMA said it has several Brexit work streams – including one dealing with the physical relocation of the agency from its current headquarters in London to one of the remaining member states.

According to the document the European Council is expected to choose from a list of cities bidding to host the regulator in October.

Earlier this year, health secretary Jeremy Hunt indicated that the UK will have to quit the EMA because of the government’s desire to be free of the jurisdiction of the European Court of Justice.

This will make the EMA’s London headquarters location untenable, and it will have to move its base from the Canary Wharf location it has occupied since the 1990s.

Hosting the EMA is seen as a magnet for the pharmaceutical industry, and pharma companies have cited the agency’s location as a factor when deciding on investing in the UK.

That is why member states from Ireland to Romania are bidding to host the EMA, as it as seen as a catalyst for growth of the life sciences industry.

Another Brexit issue the EMA is wrestling with is redistributing work formerly conducted by the UK’s drugs regulator, the MHRA.

The MHRA often takes a lead role when medicines are assessed using the centralised process, and as one of the larger EU regulators it also conducts work such as safety monitoring.

All of this must be distributed between the other regulators and the EMA has set up two working groups, one focused on human medicines, and one dealing with veterinary medicines, which will explore how to relocate this work across the rest of the network.

The EMA has also produced guidance for pharma companies to help them adapt processes and consider changes to marketing authorisations to ensure they remain valid.

 

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