Abstract

Italy is carrying on campaigning strongly to have Milan as the next seat for the EMA. Should this occur, the fact of having both the EMA and the EFSA – offices of the latter are in Parma – in Italy would mean creating a sort of European FDA authority in the country.

Soon, everything could be centered on Italy in terms of approval, safety and regulations on pharmaceutical products. In the foreseeable future, drugs and medical devices may in fact be approved for market or withdrawn from it by an Italy-based authority.

As a result of the UK’s decision to leave the EU – the exact timing and conditions for Brexit to occur are still quite uncertain however - the European Medicines Agency (EMA) will have to be relocated elsewhere in the European Union.
Italy is one of the strongest candidate-countries to host the EMA, while Sweden, France, Denmark, Hungary and Bulgaria are also among those making pitches.

Nothing has been decided yet, not even whether the EMA should indeed be moved, though relocation seems very likely if we consider that the UK is strongly opposing moving the EMA outside of the UK, clearly being aware that the risk of losing the advantages of hosting a EU agency of this caliber does indeed exist.

EMA employs approximately 900 people, who shape and oversee the regulations of a pharmaceutical market that serves 500 million patients / end users.

As well as the international prestige, there ...