Dear Shahnaz, I have been checking to see if anyone had replied to you since this post went up and I am imagining there might be a few people out there with answers for you, but we are all in a 'watch and wait' mode until further guidance documents are released by the EU Commission.

I am by no means a regulatory expert but am happy to provide my understanding and I welcome other members of the forum to add to this, based on what is happening within their organisations.

It is my understanding that :
The Regulation 536/2014 will be applied NO EARLIER than 28 May 2016. For any trials that have been submitted under the existing Clinical Trials Directive i.e. currently ongoing, then those trials can continue under that Clinical Trials Directive for 3 years.

Please note that the EU Commission is working on the EU portal that will be used by organisations to submit their electronic regulatory applications in accordance with the Regualtion. The readiness of the portal will be important in deciding when the Regulation can be implemented e.g. if there is no functioning portal available, then the process for single electronic appilications cannot occur. I have seen it mentioned that the Regulation only becomes effective 6 MONTHS after the portal has been declared fully functional (this can be no earlier than 28th May 2015).

I am not aware of any summary of changes e.g. Directive vs Regulation. If anyone knows of it, it would be useful to share on this forum or indicate where it is available.

The 25 years for TMF archiving, I would not be sure of a correct answer there : maybe this will be clarified in further guidance documents. As I understand it, further guidance documents could be released by the EU Commission, EMA and possibly the CTFG.

That is the best I can offer so it would be good to see what other comments people may have.
Best wishes,
FW