Where is Industry Getting it Wrong? A Review of Quality Concerns Raised at Day 120 by the Committee for Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions for Chemical Entity Medicinal Products

• Main Authors: John Joseph Borg (Author), Jean-Louis Robert (Author), George Wade (Author), George Aislaitner (Author), Michal Pirozynski (Author), Eric Abadie (Author), Tomas Salmonson (Author), Patricia Vella Bonanno (Author)
• Format: Book
• Published: Frontiers Media S.A., 2009-08-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

ABSTRACT - Purpose. The aim of this study was to identify common trends in the deficiencies identified in the quality part of the dossier during the evaluation of marketing authorisation applications for medicinal products for human use submitted through the EU's centralised procedure. Methods....