Clinical Trial Applications

A Clinical Trial Application (CTA) is a dossier submitted to the competent National Regulatory Authority(ies) in order to seek permission to perform a clinical trial in a particular country. It is an application with necessary information on investigational medicinal products.

In the European Union (EU), CTAs are governed by Regulation (EU) No. 536/2014 on Clinical Trials. The regulation aims to establish high standards of safety and transparency for clinical studies. Four types of CTAs exist.

Types of CTAs

  • 01

    Initial Application — When requesting a new clinical study in the EU, the sponsor must submit an initial application.
  • 02

    Application for Substantial Amendment — This application is submitted when substantial adjustments to an authorized clinical trial are necessary.
  • 03

    Non-Substantial Modification Application — This application is submitted when non-substantive alterations to an authorized clinical trial are required.
  • 04

    Additional MSC Application — If an additional member state is added to an authorized clinical trial, an additional MSC application is required.

To review CTAs, designated regulators from competent authorities are appointed. The trials are reviewed according to the authority’s specified regulations and timetables.

Sponsors must submit compliant CTAs as they are a vital part of the clinical study approval process. CEBIS can be reached at for information on CTA submission process.

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