What is the EMA and what tasks does it fulfil?

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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