Журнал клинических случаев

Strategies Followed for the Assessment of the Advanced Therapies by European Medicines Agency

Abstract

Raja Rajeswari Kamisetti*

The present study intended at the responsibility and strategies of European Medicines Agency which is a decentralised bureau of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the European Union. The study carried out on the role of European Medicines Agency in the advanced therapies and ensure the assessment of European Medicines Agency in the evaluation of Advanced therapy Medicinal Products and to study the independence of its scientific assessments towards its open and translucent policy. It was focused on its scientific expertise together in the framework of European medicines regulatory network and the procedure of team work and commitment of the Committee in agreement with the regulations following GMP, GCP and GLP. Ultimately, the complete support and guidance given to the Companies researching, developing and manufacturing Advanced Therapy Medicinal Products.