title: Special considerations concerning regulatory requirements and drug development for peptides and biotech products in the EU.
abstract: 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) 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.
authors.affiliation: F. Hoffmann-La Roche AG, Basel, Switzerland. andrea.braun@roche.com
authors.forename: A
authors.initials: A
authors.lastname: Braun
authors.forename: R
authors.initials: R
authors.lastname: Gassmann
authors.forename: K
authors.initials: K
authors.lastname: Kraus
authors.forename: G
authors.initials: G
authors.lastname: Lorenzi
authors.forename: U
authors.initials: U
authors.lastname: Weigel
mesh_terms: D001709:Biotechnology / Q000331:legislation & jurisprudence* / Q000592:standards*; D005062:European Union; D007880:Legislation, Drug; D011994:Recombinant Proteins / Q000096:biosynthesis / Q000627:therapeutic use / Q000633:toxicity
chemical_list: D011994:Recombinant Proteins