Intended for healthcare professionals


EU’s new clinical trial system aims to streamline approvals and improve transparency

BMJ 2022; 376 doi: (Published 26 January 2022) Cite this as: BMJ 2022;376:o228
  1. Elisabeth Mahase
  1. 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 …

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