Regulatory Authority in Europe is European Medicines Agency (EMEA). The European Medicines Agency relies on the results of clinical trials carried out by pharmaceutical companies to reach its opinions on the authorisation of medicines. Although the authorisation of clinical trials occurs at Member State level, the Agency plays a key role in ensuring that the standards of good clinical practice (GCP) are applied across the European Economic Area (EEA) in cooperation with the Member States. It also manages a database of clinical trials carried out in the European Union. The European Medicines Agency (EMEA) is a decentralized body of the European Union with headquarters in London.

This topic describes: EMEA, National authorization procedures, Good Clinical Practice – Human Medicinal Products, GCP Inspectors Working Group.

Regulatory Environment in Europe

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