EU’s new clinical trial system aims to streamline approvals and improve transparencyBMJ 2022; 376 doi: https://doi.org/10.1136/bmj.o228 (Published 26 January 2022) Cite this as: BMJ 2022;376:o228
- Elisabeth Mahase
- The BMJ
The EU Clinical Trials Regulation is set to come into effect on 31 January 2022 and will include a new streamlined system for trial sponsors and regulators, the European Medicines Agency (EMA) has announced.1
The Clinical Trials Information System (CTIS), which comes after a decade of work, will mean sponsors no longer have to submit clinical trial applications separately to each of the 30 national authorities and ethics committees. It also provides a single place where results can be published and will include a searchable database for healthcare professionals and the public.
The regulation will apply to EU and the …