title: Overhauling oversight--European drug legislation.
abstract: At the end of next month, the European Medicines Agency (EMEA) will implement a new legislative framework and several provisions that seek to provide incentives and streamline regulatory oversight of certain monoclonal antibodies and other biologic products.
authors.affiliation: Pharmaceutical and Medical Devices Regulatory Practice of Arnold & Porter LLP, Tower 42, 25 Old Broad Street, London EC2N 1HQ, UK. lincoln_tsang@aporter.com
authors.forename: Lincoln
authors.initials: L
authors.lastname: Tsang
mesh_terms: D000911:Antibodies, Monoclonal / Q000737:chemistry; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000639:trends; D004348:Drug Labeling; D015507:Drugs, Investigational; D005060:Europe; D007880:Legislation, Drug; D008004:Licensure; D004364:Pharmaceutical Preparations; D013997:Time Factors; D006113:United Kingdom
chemical_list: D000911:Antibodies, Monoclonal; D015507:Drugs, Investigational; D004364:Pharmaceutical Preparations