EU regulatory frameworks and pharmaceutical law
This article describes the legal and administrative frameworks and procedures for the regulation, grant of marketing authorization and subsequent safety vigilance activities required to comply with European law within member states of the European community.
In particular we consider the components of the submission dossier for authorization, the methodologies used to evaluate the appropriate risk: benefit of new medicinal products and the different procedures used in submission to ensure harmonization of product authorizations and details throughout the EU.
The European system for regulating the manufacture and distribution of medicinal products developed in the years following the thalidomide disaster in the early 1960s. Over the past few years there have been dramatic changes in the way the pharmaceutical industry discovers and develops new products. For instance the production of recombinant macromolecules and monoclonal antibodies, the development of the new oligonucleotide biochemistry and other molecular biological approaches to therapeutics are transforming the industry. These scientific advances have to be closely matched by new regulatory methodologies to evaluate the safety and efficacy of a new medicinal product such that an appropriate benefit risk profile for a particular patient group wit