EU CENTRALIZED APPROVALS PROCESS COULD BE IMPEDED BY POLITICAL PRESSURES; SINGLE INDICATION, TRADEMARK UNDER CENTRALIZATION ARE PROBLEMATIC
Executive Summary
The regulatory step following product approval by the European Union's Committee for Proprietary Medicinal Products, during which the decision is referred to the European Commission for final sign-off, "is a purely political process," attorney Ansis Helmanis of the D.C. firm Barnes, Richardson & Colburn asserted at an Institute for International Research conference on "Global Regulatory Strategies" in Washington Sept. 13.