EU Regulatory Review – What Pharma Should Remember From 2017

 
• By Maureen Kenny
  
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You could be forgiven for thinking that Brexit was the only story in town on the European regulatory front in 2017, but there were of course plenty of other important developments during the year.

2017 into 2018
As 2017 draws to a close, Scrip looks back at EU regulatory changes over the year • Source: Shutterstock

In 2017 the landmark mutual recognition agreement between the EU and the US on pharmaceutical inspections finally became operational. The European Commission published its long-awaited report on ten years of the EU Paediatric Regulation, but the implementation date of the new EU Clinical Trials Regulation was put back yet again. PRIME, the European Medicines Agency’s priority medicines scheme for speeding up access to medicines for unmet medical needs, is now well and truly a fixture on the EU regulatory scene.

The EMA’s policy on the proactive publication of clinical data passed its one-year anniversary, and patient involvement in the medicines...

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