Copyright (c) 1996 Elsevier Science B.V. All rights reserved.
The marketing authorization for a new medicinal product is based on the scientific assessment of its quality, safety and efficacy.
The marketing authorization application (MAA & rpar ; which covers all the relevant documentation can be filed in the EU via different application procedures.
For peptides and biological products special issues have to be taken into consideration during drug development.
Due to special production procedures and the complexity of the active substance itself, peptides and biotech products are subject to specific regulatory requirements.
This leads to the necessity to discuss the development program of a new peptide or biotech product with the health authorities on a case by case basis.
This article will focus on the special regulatory requirements for peptides and biotech products including the registration procedures as well as technical, preclinical and clinical issues.
Mots-clés Pascal : Peptide, Macromolécule biologique, Biotechnologie, Protéine recombinante, Développement produit, Législation, Réglementation, Médicament, Enregistrement, Procédure, Spécificité, Essai préclinique, Essai clinique, Procédé fabrication, Etats Unis, Amérique du Nord, Amérique, Documentation, Article synthèse
Mots-clés Pascal anglais : Peptides, Biological macromolecule, Biotechnology, Recombinant protein, Product development, Legislation, Regulation, Drug, Recording, Procedure, Specificity, Preclinical trial, Clinical trial, Manufacturing process, United States, North America, America, Documentation, Review
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 97-0078735
Code Inist : 002B30A08. Création : 21/05/1997.