Clinical Trial Experts Group (CTEG)
Clinical Trials Coordination Group (CTCG), Heads of Medicines Agencies (HMA)
"In order to simplify the re-submission process to CTIS CTCG accepts that the CT numbers within the documents uploaded into the system are shortened concerning the last 2 digits which only show how often the sponsor created previous submissions and re-submitted the applications.
In case of a decision letter the full number including the last 2 digits will be reflected.
If the full number is reflected in the documents and a re-submission takes place, there is no expectation that these numbers are immediately corrected within the documents during the ongoing procedure. This can be done at a later stage when the documentation is updated during a SM procedure."
bron: HMA CTCG Key documents list
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"The new Clinical Trial Regulation EU No. 536/2014 and Implementing regulation (IR) which came into force on 31 Jan 2022 introduced the concept of safety cooperation and work-sharing among Member States (MSs)
Joint Action (JA) 12 of the EU4Health Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials or SAFE CT supports these new concepts through provision of additional resources and expertise necessary to implement the new regulation.
The goal of this JA is to establish and maintain cooperation in safety data assessment in clinical trials via building capacities and performing training activities in the participating MSs. The experience gained during the JA will be used to update and improve the procedures on cooperation and training in safety surveillance in clinical trials.
The project is currently in grant agreement preparation phase and will run for 36 months (with a retrospective start date from 01/05/2022 – 01/04/2025)."
bron: HMA CTCG SAFE CT
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Clinical Trials Information System (CTIS): Protection of personal data and commercially confidential information
Etiketteringsvoorschriften voor niet-toegelaten geneesmiddelen en auxiliaire geneesmiddelen
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