title: Biopharmaceuticals approved in the EU 1995-1999: a European Union-United States comparison.
abstract: The European Union's (EU) centralized procedure for new drug review was implemented in 1995 to unify the regulatory process and provide EU-wide marketing authorizations for innovative medicinal products. Goals were instituted to ensure the timeliness of the various steps of the process. The EU approved 27 biopharmaceutical products through the centralized procedure during 1995-1999. This study documents the success of the EU in meeting the timeline goals for the group and for separate categories of biopharmaceuticals (recombinant proteins, monoclonal antibodies, and antisense oligonucleotides). A subset of the 27 biopharmaceuticals approved in the EU were also approved in the United States (US). We compared EU and US approval times for these products by product category and by review status (exceptional/non-exceptional circumstance in the EU and priority/standard in the US).
authors.affiliation: Tufts Center for the Study of Drug Development, Boston, MA 02111, USA. janice.reichert@tufts.edu
authors.forename: J M
authors.initials: JM
authors.lastname: Reichert
authors.forename: E M
authors.initials: EM
authors.lastname: Healy
mesh_terms: D001702:Biopharmaceutics; D017277:Drug Approval / Q000706:statistics & numerical data*; D005062:European Union; D005569:Formularies as Topic; D014481:United States