Update ECTR timelines to OCT 18
Following this EMA Board meeting on 17th Dec, the agency made public the minutes of the meeting endorsing a Dzgo live Dz database in Sept 18 and a Clinical Trial Regulation becoming applicable in Oct 18 as per the below timeframe.
A three year transition period is foreseen in Article 98 of the Regulation. These three years are counted from the date of its application.
During the first year of that transition period clinical trial applications may be made either under the new Regulation using the EU portal and database, or under Directive 2001/20/EC.
For the following two years clinical trials authorised under the Directive will continue to be governed by that Directive.
Any trials authorised under the Directive and still ongoing 3 years after the Regulation comes into application will from then on be governed by the Regulation.
Activity and Date
1. Auditable Version released for audit, including implementation of auditable and non-auditable must requirements, July 2017
2. Independent Audit commences, August 2017
3. Development of remaining requirements commences, August 2017
4. Independent Audit completed, November 2017
5. Audit endorsed by EMA Management Board, December 2017
6. European Commission notice published in Official Journal of the European Union, March 2018
7. Production Version completed, including implementation of remaining should requirements, July 2018
8. Production Version go-live, September 2018
9. Regulation (EU) No 536/2014 becomes applicable, October 2018