The EU Clinical Trials Regulations 2016 - implentation in the UK?

[a123456]

You should remember that the EMA said that :- "This is a maximum timeline and every effort will be made to bring the Regulation into application as soon as possible....progress of implementation of the system will be closely monitored ...and hence application of the Regulation to an earlier time as possible".
The EU clinical trials portal and Union database stakeholders meeting (08Dec2015) their plan, stated (information issued 15 Dec 2015), that the regulation would apply from 4Q 2017.

So the timeline of Oct 2018 is a maximum, but the people working on the portal think that the Regulation may apply from 4Q2017. Be prepared!

[a123456]

The EU clinical trials portal and Union database stakeholders meeting (Feb 2016) has now updated their timeline and it is the same as the EMA document - regulation applies Oct 2018. But it should still be remembered that :- "This is a maximum timeline and every effort will be made to bring the Regulation into application as soon as possible....progress of implementation of the system will be closely monitored ...and hence application of the Regulation to an earlier time as possible".

[a123456]

Of course the story still continues! In October 2019 the EMA posted:--

Update: In October 2019, EMA's Management Board endorsed the six-monthly monitoring report on the development of the CTIS, which assesses the performance of the IT supplier against agreed key performance indicators. The Board agreed that actions proposed in the report should be further developed, for example improving the quality of the work delivered by the supplier and selecting the critical items needed for audit, as well as extending the monitoring period for at least three releases.
The product owners validated the first release developed in the agile, iterative delivery in September 2019, confirming that all 79 items had been delivered.
The release enhanced CTIS functionalities for the submission of clinical trials and the assessment process, user management and included other general improvements.
The product owners will begin to carry out an operational assessment of the system to identify critical business blockers, in order to enable EMA's Management Board to consider the timing of the audit of the system.