Consultation on revision pediatric guidance document

Consultation on the revision of “Ethical Considerations for Clinical Trials on Medicinal products Conducted with Minors”: a response from Enpr-EMA and partners.

As you know, the EU Clinical Trials Regulation 536/2014 is to come into application in October 2018.
On 01 June 2016, the EU Commission issued a draft guidance document for consultation for the application of the Clinical Trials Regulation, i.e., “Ethical Considerations for Clinical Trials on Medicinal products Conducted with Minors”.

During the European network of paediatric research at EMA (Enpr-EMA) annual meeting on 02 June 2016 in London, it was agreed that a consolidated review document including Enpr-EMA and its working groups (representatives of Networks, National Competent Authorities, pharmaceutical industry and CRO) would be prepared and be submitted to the EU Commission by Enpr-EMA.

EUCROF was a major contributor in the preparation of the comment document. See attached the version submitted. I wish to thank Martine Dehlinger-Kremer very much for her involvement in writing the document and Sergii Myronenko for his review of the draft guidance and his valuable input.

Best regards to all
Stefano

Consultation document
Regulations
Consultation on the revision