Aucune remarque pour cette diapositive
Étant donné que toutes les grandes institutions de l&apos;UE - le Parlement, la Commission et le Conseil (ministres des Etats membres) - ont été impliquées dans les négociations qui ont conduit à l&apos;accord de Décembre 2013, on ne s&apos;attend pas à ce que le Comité et le Parlement introduisent des changements majeurs dans le texte, a dit un porte-parole ENVI.
The reporting MS will assess the application and prepare an assessment report (Part I) with a conclusion on the trial’s acceptability (ie acceptable, acceptable but subject to compliance with specific conditions, or not acceptable). This will be based on: anticipated therapeutic and public health benefits; risks and inconveniences for the subject; compliance with rules on manufacturing and importation of investigational medicinal products and auxiliary medicinal products; compliance with labelling requirements; and completeness and adequacy of the investigator’s brochure.
In parallel, each MS carries out a Part II assessment on aspects that are intrinsically national, ethical, or local aspects. This covers an assessment of: compliance with informed consent requirements, arrangements for compensating investigators and subjects, subject recruitment, data protection, suitability of trial sites, suitability of individuals involved in conducting the clinical trial, damage compensation, and compliance with rules on collection, storage and future use of biological samples.
The Commission has incorporated risk-proportionality into assessments in that timelines are dependent on whether the trial is &apos;low intervention&apos;, &apos;other than low intervention&apos; or an advanced therapy medicinal product.
The proposed Regulation does not establish a central body to co-ordinate assessments; however, a co-ordination and advisory forum, managed and chaired by the Commission, would be created to address issues that may arise during the authorisation procedure.
The Commission leaves to each Member State concerned the authority to determine the appropriate body or bodies to be involved in the assessment. However, the proposed Regulation would require each Member State to designate one national contact point in order to facilitate the functioning of the assessment and decision procedures.
Do you want to mention that this builds on the VHP?