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Europe Daily Bulletin No. 13104

21 January 2023
SECTORAL POLICIES / Health
European Clinical Trials Information System should be fully operational by end of transition to new regulation
Brussels, 20/01/2023 (Agence Europe)

The one-year transition period that followed the entry into force of the new Clinical Trials Regulation (Regulation EU/536/2014, also known as CTR) will end on 31 January. During this transitional period, clinical trial sponsors had the option of submitting an application for a new clinical trial through the national submission procedures under the old regulation (Directive 2001/20/EC) or submitting their application through the Clinical Trials Information System (CTIS) under the new...

Contents

SECTORAL POLICIES
ECONOMY - FINANCE - BUSINESS
EXTERNAL ACTION
COURT OF JUSTICE OF THE EU
NEWS BRIEFS