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Relationship between receiving authorities and monitoring authorities. The EMEA experience.

Authors
  • Cuddy, Brendan James
Type
Published Article
Journal
Annali dell'Istituto superiore di sanità
Publication Date
Jan 01, 2008
Volume
44
Issue
4
Pages
357–358
Identifiers
PMID: 19351995
Source
Medline
License
Unknown

Abstract

The approach of the European Medicines Agency (EMEA) to good laboratory practice (GLP) inspections in the context of authorization of medicinal products is illustrated with particular reference to the EMEA's experience as a receiving authority (RA), the procedures it has in place for the reporting and follow-up of GLP inspections, and the role of the ad hoc GLP inspectors working group. Other key issues dealt with are the relationship between the EU monitoring authorities (MAs) and the EMEA as a specific RA, how inspections outside the EU are handled and some aspects (exchange of information, handling of non-compliance, triggers for inspection) that have been raised during recent inspections.

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