Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers.

ABSTRACT:

Background and objective

Biological medicinal products (biologics) are subject to specific pharmacovigilance requirements to ensure that biologics are identifiable by brand name and batch number in adverse drug reaction (ADR) reports. Since Member States collect ADR data at the national level before the data is aggregated at the European Union (EU) level, it is important that an unambiguous understanding of which medicinal products belong to the biological product category exists. This study aimed to identify the level of consistency between Member States regarding the classification of biologics by national authorities responsible for ADR reporting.

Methods

A sample list of recombinant biologics from the European Medicines Agency database of European Public Assessment Repor

SUBMITTER: Klein K 

PROVIDER: S-EPMC4684580 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature