Clinical Trials Coordination and Advisory Group (CTAG) - Hoofdinhoud
Deze expertgroep [EU] i (nr. X03839) adviseert de Europese Commissie (Directoraat-generaal Gezondheid en Voedselveiligheid (SANTE) i) bij het opstellen van nieuwe wetgeving en nieuw beleid. Expertgroepen zijn samengesteld uit deskundigen van nationale overheden, vertegenwoordigers van belangenorganisaties en/of experts uit het bedrijfsleven.
Details
Abbreviation: CTAG
Policy Area: Public Health
Lead DG: DG Health and Food Safety
Type: Formal
Scope: Limited
Mission: In order to assist the Commission to support the effective and efficient implementation of the Clinical Trials Regulation (EU) No 536/2014, including also its implementing acts, Member States will coordinate and collaborate through their designated national contact points in the Clinical Trials Coordination and Advisory Group
Task: Assist the Commission in relation to the implementation of existing Union legislation, programmes and policies
Contact: -
Publication in RegExp: 18/02/2022
Creating Act: -
Last updated: 10/07/2023
Additional Information
Activity report: The CTAG’s tasks shall be those provided in Articles 84 and 85 of the CTR, in particular: 1.To support the exchange of information between the coordination and cooperation with Member States and the Commission on the experience acquired with regard to the implementation of the CTR, such as the submission and assessment of Clinical Trial Applications and clinical trials oversight by Member States; 2.To advise the Commission to ensure the harmonised implementation of the CTR and its relevant implementing and delegated acts and provide expert level consultations during the preparatory work of delegated Acts. 3.To assist the Commission in supporting the functioning of the cooperation of Member States for the assessment of safety reports, as described in the Implementing Regulation (EU) 2022/20. 4.Prepare recommendations on criteria for the selection of Reporting Member States. 5.The work of CTAG shall be part of a broader policy agenda to improve clinical research in the EU, in collaboration with the relevant groups of the Heads of Medicines Agency network and the European Medicines Agency. Duplication will be avoided. 6.To draw up its rules of procedure, which will be made public, as referred to in Article 85(6) of the CTR.
Selection procedure: Article 85 of the Clinical Trials Regulation (EU) 536/2014 (“CTR”) sets up a Clinical Trials Coordination and Advisory group (CTAG), composed of the national contact points, nominated by each Member State for that Member State (Art 83 CTR). The Clinical Trial Regulation (“CTR”) will start to be applicable as from 31 January 2022 In accordance with Article 83.2 of the CTR, the name of the national contact points and a contact email of the members or their affiliate association shall be published on EudraLex - Volume 10 (europa.eu) .
http://EudraLex - Volume 10 (europa.eu)
Other: regulation
http://EUR-Lex - 32014R0536 - EN - EUR-Lex (europa.eu)
CELEX_32014R0536_EN_TXT.pdf (approx. 756 kb)
Other: Rules of procedure
ROP CTAG Final_ 31 October 2022.pdf (approx. 91 kb)
Subgroups
No Subgroups assigned to this group.