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EMA survey identifies gaps in pharma industry's preparedness for Brexit

An EMA survey has identified gaps in the pharmaceutical industry’s preparedness for Brexit, finding that only 58% of market authorisation holders are on track with their regulatory planning in preparation for the UK’s exit from the European Union in March 2019.  

The survey, aimed at identifying centrally authorised products (CAPs) that are at risk of shortages following Brexit, identified that for 16% of the medicines surveyed, there are serious concerns the necessary procedures will not be carried out in time.

Rare diseases - pharma’s new frontier

Published on 26/03/12 at 09:35am
Micrograph image
Light micrograph of a spleen of a patient with Gaucher’s disease, the inherited metabolic disorder treated by Genzyme’s Cerezyme

The last ten years has seen our understanding of rare diseases move ahead rapidly, often thanks to greater understanding of genetic problems, which are behind 80% of rare diseases. 

For the pharma and biotech industry, this has made rare diseases an increasingly important area for research - and this is matched by the commercial potential. 

Another factor influencing the industry’s move towards rarer diseases is the fact that breakthroughs in the most widespread problems - hypertension or asthma for example - have become harder to achieve. 

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