Chapter 9: The Changing Face of European Drug Registration

The changing face of european drug registration Until the mid-1990s, drug registration in Europe was the prerogative of regulatory authorities in each country. On January 1, 1995, however, the countries of the European Economic Area (EEA) (the member states of the European Union [EU] plus Iceland, Liechtenstein, and Norway) inaugurated the European Agency for the Evaluation of Medicinal Products (commonly known as the European Medicines Evaluation Agency [EMEA]). The European Commission states that the EMEA is charged with “pooling the scientific expertise of member states in order to ensure a high degree of protection for public health, ensuring free movement of pharmaceuticals, and making certain that Europeans have access to new generations of medicinal products.” The creation of the EMEA was arguably the first significant milestone on the long road to a single European market for pharmaceuticals. After almost a decade of activity, the EMEA has transformed the drug registration ...

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