Related Experiment Video
Updated: Aug 5, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation
Stéphane Vignot1, Gaelle Guyader1, Valérie Salomon1
1Agence Nationale de Sécurité du Médicament et des Produits de Santé, Boulevard Anatole France, 93200, Saint Denis, Grand Paris, France.
Abstract:
The implementation of the new European Clinical Trial Regulation on 31 January 2022, is a major step to promote clinical research in Europe. The French National Agency for Medicines and Health Products Safety (ANSM) proposes to share some key aspects of the preparation for the application of the Regulation initiated in 2017 and to discuss shared indicators that should be considered to monitor clinical trials opportunities on a territory with regards to access to innovation for patients and attractiveness for sponsors. New criteria based on the time from the first request for authorisation to the first inclusion could be of particular interest to appraise the implementation of the European Clinical Trial Regulation.
Related Concept Videos
Clinical Trials: Overview
Clinical Trials
There are four phases in a clinical trial. A phase one...
Preclinical Development: Overview
Drug Regulation
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

