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Updated: Oct 8, 2026

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
Published on: September 15, 2023
[European Agency for the Evaluation of Medicinal Products: five years experience]
Abstract:
The "European Agency for the Evaluation of Medicinal Products" (EMEA) is since 1995 primarily responsible for the scientific evaluation of applications for a European marketing authorisation for medicinal products derived from biotechnology and other high technology (centralised procedure). For other products, the EMEA arbitrates where mutual recognition of national marketing authorisations between the Member States is not possible (decentralised procedure). European patients are now able to have speedier access to new drugs, usually within one year. The new system also helps to reinforce the safety of medicines for humans and animals, particularly through a pharmacovigilance network and the establishment of safe limits for residues in food-producing animals.
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