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16 wrz 2022 · Under the clinical trial regulation (CTR), authorisation of the clinical trial application (CTA) has to occur through a new process: a single dossier has to be submitted to the one portal (EU Clinical Trial Information System [CTIS]).
Under the Regulation, clinical trial sponsors must submit all new clinical trial applications in the Clinical Trials Information System (CTIS) from 31 January 2023. National regulators in the EU Member States and EU/EEA countries also use CTIS.
public access to information on the Clinical Trial Information System (CTIS). This material describes a preliminary version of CTIS and may therefore not entirely
Clinical Trials Applications (CTAs) to DAIDS to ensure compliance with ICH E6. This document provides guidance to In-Country Sponsor Representatives that prepare and submit CTAs to the competent National Regulatory Authority(ies) for authorization to conduct a clinical trial in a specific country. Background:
A Clinical Trial Application (CTA) is a Regulatory dossier that is submitted to the Health Authority (HA) of the country in which a sponsor would like to conduct clinical trials with Investigational Medicinal Products (IMPs) or with approved drugs to explore new indications.
Content and structure of a clinical trial application Content and structure of the CTA dossier is in line with Annex I of the CT Regulation. The initial application can be of two types: • Full initial: all the MSC receive part and part II (Article 5) • Partial initial: all MSC receive part I and some, or none, of the MSC receive part II ...
23 paź 2023 · As of 31 January 2023, the EU only accepts CTAs that are submitted via the Clinical Trial Information System (CTIS; learn more about this clinical trial database in this blog). A CTIS submission includes the IMPD and cannot accommodate eCTD sections or structure.
