Prescription Drug Approval Process: Europe

In years past in the European Union (EU), medical products were approved for marketing at the national level. However, beginning in 1983, a mutual recognition procedure was established, and a single national review for pharmaceutical/medicinal products for all EU countries was made a reality.

The primary aim of this procedure was to create a unified standard for product review among all involved national regulatory authorities. A few years later, in 1987, a concentration procedure was established for biologically derived and high-technology products by directive 87/22. This stated that the Committee for Proprietary Medicinal Products (CPMP) should complete product assessment, along with the traditional national regulatory review. Then, in 1993, by council regulation (EED), this procedure was replaced with a centralized procedure, by which all of these ...