Peter O’ Donnell

The European Union's extensive links with the US FDA and Health Canada have reached a further level of maturity, writes Peter O' Donnell.

The entry into force of the new EU clinical trials regulation last June is really little more than a virtual event. The new rules will apply only once the EU Clinical Trials Portal and Database now under development are fully operational.

So at last it’s happened. Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation.

This week (February 28), Europe will celebrate Rare Disease Day. This is an interesting example – one might almost say a rare example – of a successful attempt by a European interest group to capture public attention.

As the United Kingdom debate about whether to stay in the European Union becomes more bitter and intense, an insight into how EU membership impacts on medicines and pharmaceuticals has appeared from a British politician who was until recently the UK Government Adviser on Life Sciences, George Freeman.

Although a broad compromise was reached in late December on the future shape of the European Union’s clinical trials rules, there are still many details to be resolved – including on that perennial issue of data transparency.