What is the EMA and what tasks does it fulfil?

28.10.2024

Question of the Week

The European Medicines Agency (EMA) has been responsible for the authorisation of innovative and biotechnologically manufactured medicinal products in a centralised procedure since 1995. Before finalising the assessment process, the responsible committee can have a GMP inspection carried out. In the mutual recognition authorisation procedure, the EMA has a mediating function in the event of differences of opinion between the Member States concerned.

[GMP Compliance Adviser, Chapter B.2]

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