EMA has announced that the EU portal ‘Clinical Trials Information System’ is expected to go live in December 2021

18-06-2020 / Daniela van 't Ent - Ifrim / Legislation

Clinical Trials Information System (CTIS), initially published in May 2014, is expected to go live in December 2021. From that moment on, the EU Regulation on research with a medicinal product will apply as well. CTIS is built for the implementation of EU Regulation 536/2014 and will become the central portal for the submission and review of research with a medicinal product in the EU.

The CTR implementation will trigger the repeal of the current GMP Directive 2003/94/EC and its replacement by Directive 2017/1572 (marketed products) and delegated Regulation 2017/1569 (GMP and inspections of IMPs). Annex 13 will be replaced by revised GMP for IMPs that was published in 2017.

As soon as the Regulation applies, a transitional period of three years will commence. In the first year of the Regulation, research with a medicinal product may still be submitted in the current manner or via CTIS.

For more information regarding the EMA Highligts of Management Board: June 2020 meeting, see here.