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Notulen CTAG vergadering oktober gepubliceerd
Op 19 december 2022 zijn de notulen gepubliceerd van de vergadering van de Clinical Trials Coordination and Advisory Group (CTAG) die op 19 oktober 2022 heeft plaatgevonden.
Hieronder heb ik een aantal interessante snippets uit de notulen overgenomen die betrekking hebben op de Clinical Trials Regulation (CTR):
Survey on CTR implementation: blocking issues, solutions, and the way forward
The EMA informed that major blockers that are preventing the users to work smoothly on CTIS have been identified and that the service providers were committed to solve these blockers before 31 January 2023, date from which the use of CTIS will be compulsory. Member States expressed concerns about CTIS performance and some of the persisting blocking issues, calling for a fully operational system to be delivered on time. The Commission joined this call and encouraged good coordination at national level to ensure that the positions expressed at the EMA management board reflect the Member States needs expressed in this group. The Commission announced that the next steps would consist in identifying the persisting issues, prioritising them and allocating them to the different entities for possible resolution (EMA, Commission, Member States, CTAG, Commission Expert Group on Clinical Trials (CTEG), Clinical Trial Coordination Group (CTCG)). A sub-group of CTAG would be set up to prepare the work of an ad hoc CTAG plenary meeting in December 2022 dedicated to that follow-up.
Union Controls
The Commission recalled the concerns expressed by Member States concerning the scope of the Union controls performed in the frame of the CTR. Notwithstanding that Union Controls is a critical method to verify whether Member States correctly supervise compliance with the CTR, the Commission has decided to pause the Union Controls until there is an internal review of the legal provisions. In relation to those Union Controls that had already started, the Commission has been liaising bi-laterally with the concerned Member State to seek agreement as to how to proceed.
Proposals by ES and NL to facilitate clinical trial applications and CTR implementation
ES and NL presented a set of proposals to facilitate clinical trial applications and the CTR implementation. These proposals consisted in rationalising and optimising the work of the different groups involved in the implementation and enforcement of the CTR, updating and complementing guidance materials, developing a kit of first understanding of the CTR (a document summarising the new rules and pointing to the different guidance materials). The Commission welcomed these proposals and indicated that they will be considered, notably in the context of the survey follow-ups. Collaboration with the CTEG and other interested parties will be sought as appropriate.
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