Traduction de «Mise à l'essai d'un nouveau médicament pour les animaux » (Français → Anglais) :

new animal drug application

In those clinical trials the investigational medicinal products are used in accordance with the marketing authorisations, and the individual subject receives a standard treatment regardless of whether he or she accepts or refuses to participate in the clinical trial, or withdraws from it, so that the only consequence of non-participation is that data relating to him or her are not used for the clinical trial.

the relevance of the clinical trial, including whether the groups of subjects participating in the clinical trial represent the population to be treated, or if not, the explanation and justification provided in accordance with point (y) of paragraph 17 of Annex I to this Regulation; the current state of scientific knowledge; whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products; and, where applicable, any opinion formulated by the Paediatric Committee on a paediatric investigation plan in accordance with Regulation (EC) No 1901/2006 of the European Parliament ...[+++] and of the Council

The risk to subjects participating in clinical trials varies depending whether the trial is to test a new medicine or to compare existing medicines.

A typical late-stage trial of a novel intervention can take up to 15 years with a development cost of between 500 to 800 million euro per new candidate drug or vaccine.