The release of the portal and the EMA database shift to 2020

ema-kCEH--258x258@Quotidiano_Sanita-WebThe news, mentioned in hypothesis during the DIA Europe Congress that took place in Basel last April, but now it finds confirmation in the article Why the EU’s New Clinical Trials System is Taking So Long that Ian Schofield posted on the Pink Sheet 31 May. Technical complexities have pushed back the finalisation of the clinical trial portal and database system to early or mid-2020.

The system was initially scheduled to be up and running in September 2018, but problems with its development have meant that the deadline is continually being pushed back. Last year the go-live date was shifted to late 2019: now, figures given to the Pink Sheet by the European Medicines Agency suggest it could be May 2020 before the system is ready for use.

The arrival of the portal is keenly awaited by companies that plan to run multi-country trials in the EU. It will offer a single electronic entry point for all trial approval submissions. It is also a crucial part of the EU Clinical Trials Regulation (No 536/2014), as its provisions won’t take effect until six months after the European Commission has published a notice certifying that the portal and database system is fully functional.

Thanks to Robert Paarlberg, chair of the Clinical Trial Disclosure Community – DIA) for bringing this to our attention.