Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
Period of consultation
From 28 August 2015 to 24 November 2015.
Contributions to and results of the consultation
A summary of the responses is available here.
Below are the public responses to the above-mentioned public consultation:
- ACRO (Association of Clinical Research Organizations)
- AEMPS (Spanish Agency of Medicines and Medical Devices)
- AESGP (Association of the European Self-Medication Industry)
- AstraZeneca
- efpia (European Federation of Pharmaceutical Industries and Associations)
Objective of the consultation
With this public consultation the Directorate General for Health and Food Safety, DG SANTE, intends to seek the views of stakeholders – and other interested parties – on the revision of the document "Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors" in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.
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.
The consultation document
The consultation document can be downloaded here.
Protection of personal data
The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.
Specific privacy statement
Please consult the Privacy Statement to be downloaded here.