Sep23 CTAG Meeting Minutes released today

Today, the Minutes of the 18Sep23 ?Clinical Trial Coordination and Advisory Group (CTAG) Meeting were released.

The key topic (and clearly the critical one for next year) is the Transitional trials (Ongoing trials under the EU CT Directive transition to the EU CT Regulation).

From the minutes, we learn that:

• Member States announced possible adaptations and simplification of the guidance material following some questions raised at the event EMA organised on that subject. The CTAG sub-group dealing with that guidance will be reactivated to propose these changes to CTAG.
• The revised KPI report, that the EMA has been publishing on a monthly basis, now reports the number of clinical trials that have transitioned in the previous month.
• In particular, it is important to support academic sponsors and SMEs. It is noted that most of the questions come from academic and non-commercial sponsors: in the case where Member States already have specific training material for academic/non-commercial sponsors, it would be advisable to have (within the national websites listed in Annex III) a specific webpage with this material.

We can also learn from Point 4 of the minutes that the Commission services expressed intention to explore with a group of CTAG volunteers the extent the templates currently available on Eudralex vol. 10 are being used, if and how these have been adapted, and if there is the need to develop other templates within and beyond the context of the CTR. The use of common templates is a way to keep divergences of approach among different Member States to a minimum (recital 5 of the CTR).

This full review of available templates may have an important impact on the future CTA packages.

Finally, the update from DG SANTE on Union Controls (an important topic, Article 79 of EU CTR) was not very informative.

https://ec.europa.eu/transparency/expert-groups-register/core/api/front/document/99541/download