ABSTRACT
The European regulatory system has two routes for the evaluation and approval of medicinal products: (1) The centralized procedure is compulsory for medicinal products derived from biotechnology and other new chemical entities. The European Agency for the Evaluation of Medicinal Products (EMEA) reviews the license application within 210 days, and the European Commission considers the recommendations of EMEA within 90 days to issue a marketing license. (2) The decentralized procedure applies to the majority of conventional medical products.
