EU Clinical Trials New Regulation – Important Consultations HAVE YOUR SAY
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:
[B]Risk Proportionate Approaches in Clinical Trials[/B]
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:[URL="SANTE-B4-GL-risk-proportionate-approach@ec.europa.eu"]SANTE-B4-GL-risk-proportionate-approach@ec.europa.eu[/URL]
[B]Summary of Clinical Trial Results for Laypersons[/B]
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: [URL="SANTE-B4-GL-results-laypersons@ec.europa.eu"]SANTE-B4-GL-results-laypersons@ec.europa.eu[/URL]
[B]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))[/B]
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: [URL="SANTE-B4-GL-IMP-AMP@ec.europa.eu"]SANTE-B4-GL-IMP-AMP@ec.europa.eu[/URL]
[B]Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors[/B]
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: [URL="SANTE-B4-GL-Ethics-Minors@ec.europa.eu"]SANTE-B4-GL-Ethics-Minors@ec.europa.eu[/URL]
The link below will direct you to the European Commission website:
[URL="http://ec.europa.eu/health/human-use/clinical-trials/developments/index_en.htm"]http://ec.europa.eu/health/human-use/clinical-trials/developments/index_en.htm[/URL]
[B]Do not send your contributions to the MHRA, please send to the address provided by the Commission.[/B]