Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear All,

when the EU CTR becomes effective end of next year some of the current regulatory requirements in EU will become invalid (e.g. Annex 13, Directive 2001/20/EC, Directive 2005/28/EC).

Now I am wondering how this will be handled for the trials in the transition period. When some trials follow the new regulation and some trials will be conducted following the old regulation? Will I be able to follow the requirements of Annex 13, Directive 2001/20/EC etc although these will be superseded?

Thank you so much in advance,
Petra

Dear Petra,

Yes, the new regulation comes with a transition period. From the effective date, CTD and CTR are both valid for use. Within three years, all will have to switch to CTR.

There's some explanation in section 11 of the FAQ:
https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf

https://ec.europa.eu/health/sites/default/files/human-use/docs/ev_20210309_co27_en.pdf

https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation

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Anne LeBlanc
United States
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Original Message:
Sent: 14-Dec-2021 09:59
From: Anonymous Member
Subject: EU CTR and transition period, regulations to be followed

This message was posted by a user wishing to remain anonymous

Dear All,

when the EU CTR becomes effective end of next year some of the current regulatory requirements in EU will become invalid (e.g. Annex 13, Directive 2001/20/EC, Directive 2005/28/EC).

Now I am wondering how this will be handled for the trials in the transition period. When some trials follow the new regulation and some trials will be conducted following the old regulation? Will I be able to follow the requirements of Annex 13, Directive 2001/20/EC etc although these will be superseded?

Thank you so much in advance,
Petra