EMA Guidelines for Host Cell Proteins in Biopharmaceuticals


The European Medicines Agency is responsible for maintaining and promoting public health in the European Union (EU) by coordinating ongoing evaluation and surveillance of all medicinal products for human and veterinary use. Its work draws on the scientific resources of the National Competent Authorities (NCAs) of the 31 Member States of the European Union and EEA States.

The European Medicines Agency plays a central role in the authorisation of medicinal products in the European Union and the EEA states. On the basis of its scientific assessment, the European Commission issues a favourable or negative decision on applications for marketing authorisations submitted by pharmaceutical manufacturers in the centralised procedure.

With scientific guidelines, scientific advice programmes and incentives, the EMA facilitates the research and development of new medicines so that patients can concretely benefit from advances in medical science. In particular, the EMA promotes the development of drugs for children and to combat rare diseases.

Since clinical trials will often be designed as multi -centre studies, potentially involving different
Member States, one central aspect of EMA’s guidelines is to define harmonised requirements for the documentation to be submitted throughout the European Union.

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