EU Clinical Trials New Regulation – Important Consultations HAVE YOUR SAY

[MHRA Super Moderator]

EU Clinical Trials New Regulation – Major developments on Risk Proportionate Guidance; Trial Results for Laypersons; Definitions of IMP and AMPs; Ethical Considerations for Minors.
HAVE YOUR SAY

The following guidance which has been developed in preparation for the implementation of the Clinical Trial Regulation (EU) No 536/2014 is currently out for public consultation from 1 June 2016 to 31 August 2016 by the European Commission:

Risk Proportionate Approaches in Clinical Trials
The main objective of this document is to provide further information on how a risk proportionate approach can be implemented in clinical trials and highlights areas within the clinical trials Regulation which support such adaptations.

Please submit your contributions by e-mail to:SANTE-B4-GL-risk-proportionate-approach@ec.europa.eu

Summary of Clinical Trial Results for Laypersons
Article 37 of the Clinical trial Regulation (EU) No 536/2014 requires that sponsors provide a summary of clinical trial results in the EU Portal and Database, in a format understandable to laypersons. The main objective of this document is to provide recommendations and templates for the production of a summary of clinical trial results for laypersons by sponsors and investigators, in accordance with Annex V of the EU Clinical Trials Regulation.

Please submit your contributions by e-mail to: SANTE-B4-GL-results-laypersons@ec.europa.eu

Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)" (previously called "Guidance on Investigational Medicinal Products (IMPS) and Non-Investigational Medicinal Products (NIMPs))
The main objective of this revision is to align it with the Clinical Trials Regulation and with the latest (scientific) insights.

Please submit your contributions by e-mail to: SANTE-B4-GL-IMP-AMP@ec.europa.eu

Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors
The main objective of this revision is to align the document with the Clinical Trials Regulation (EU) No 536/2014 and with the latest (scientific) insights on research with children.

Please submit your contributions by e-mail to: SANTE-B4-GL-Ethics-Minors@ec.europa.eu

The link below will direct you to the European Commission website:
http://ec.europa.eu/health/human-use...s/index_en.htm

Do not send your contributions to the MHRA, please send to the address provided by the Commission.