The Guideline for Good Clinical Practice E6 (R2) Integrated Addendum has reached Step 2 of the ICH process in June 2015.
This Addendum is proposed to modernise ICH E6 to enable implementation of innovative approaches to clinical trial design, management, oversight, conduct, documentation, and reporting that will better ensure human subject protection and data quality. see also: ICH - Efficacy Guidelines
2014-05-27 Regulation (EU) No 536/2014
The new Clinical Trials Regulation (CTR) has been adopted on the 16th April 2014 and has been published in the Official Journal of the European Community. Clinical Trials Regulation will come into force no sooner than 28th May 2016.
see: Regulation (EU) No 536/2014 and European Commission - Public Health - CTR
This database should provide a valuable source of advice to people who are involved in the planning of mono- or multi-centre clinical trials within different European countries. It contains contact addresses of national authorities as well as national legislation and documents.
The TREAT-NMD Regulatory Affairs Database has been developed by the Clinical Trials Unit of the University Medical Center Freiburg within the TREAT-NMD network. In co-operation with the European Clinical Research Infrastructures Network (ECRIN) information provided in this database is updated on a regular basis (at least once a year).
(For more information please click on one of the country items below)
Additional information is available about
Please note:National and international regulations or legislation in the field of clinical trials are subject to continuous amendments. In spite of careful verification, liability for the correctness, completeness, and up-to-dateness can not be assumed. The information provided represents the authors' opinions, without making claims to their correctness or agreement with regulations, legislation or official use.
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