The European e-Submission Experience: An Applicant’s View of Different Procedures

Posted 01 June 2010 | By

The European Union (EU) presents a heterogeneous environment for regulatory submissions. There are four regulatory procedures (Centralised, Decentralised, Mutual Recognition and National). The EU comprises 27 countries and some, such as Germany, have more than one regulatory agency. In addition, there are three countries of the European Economic Area (Norway, Iceland and Lichtenstein). Finally, there is the European Medicines Agency (EMA), which operates as a decentralized agency responsible for the protection and promotion of human and animal health through the coordination of evaluation and monitoring of centrally authorized products and national referrals, developing technical guid

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