News about GMP/cGMP

28.06.2016

Brexit and EMA

With the U.K. voting to leave the EU, the speculation about a new headquarter for the European Medicines Agency EMA have started. The London-based EMA approves medicines for all EU countries. With a full-time staff of around 750, it is the largest EU body in Britain.

 

The consequences that the British exit from the EU will have for the pharmaceutical industry are not yet to be estimated. It will slow down the approvals of medicines across Europe. This includes Britain and its regulatory agency the MHRA, if it has to re-engineer its system. It might as well weaken the EMA’s scientific capability by losing British experts. According to Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries “the uncertainty this created is not good for the industry”. Britain could also choose to participate in the EMA as a non-EU member, like Norway, Iceland and Liechtenstein for example. Or it could take a more active role like Switzerland and its Swissmedic. Alternatively, UK’s MHRA could develop its own drug approval system. It is now up to the UK government to decide on how to act.

Meanwhile, officials in Italy, as drugmakers in Sweden and Denmark, or the BPI in Germany have all expressed interest in taking over as host country.

However, there will be a two-year period before any relocation decision is taken. This will be a rough time for the life science industry and the pharmaceutical industry overall.


Source:

Fierce Pharma: Pharma News



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