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Haben Sie auch schon an unseren Werbeaktionen teilgenommen?
Sind Sie als Kunde durch Werbeaktionen auf eine Fleischerei aufmerksam geworden?
Teilen Sie uns Ihre Meinung, Fragen und Wünsche mit!
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Montag, 14. September 2026 01:35 | Klosterneuburg




GLP-1 Receptor Agonists Reduce Substance use Disor
This content applies to human and veterinary medicines.
Exhaustive information about GLP can be found on the websites of the OECD and the European Commission. Questions and answers concerning the interpretation of the two GLP Directives can be found in Questions and answers concerning the implementation of Directives 2004/9/EC and 2004/10/EC on Good Laboratory Practice.
The questions were discussed by Commission services and representatives from the Member States' GLP-monitoring authorities and the answers were approved by the EU GLP Working Group. The document attempts to provide guidance to monitoring authorities, regulatory authorities and test facilities.
The answers represent the opinion of the EU GLP Working Group. The Standard operating procedure for co-ordination of good-laboratory-practice inspections describes the co-ordination of GLP inspections of the non-clinical safety, toxicological and pharmacological studies proposed in human and veterinary applications for marketing authorisations and various post-authorisation applications submitted to the European Medicines Agency through the centralised procedure.
The European Medicines Agency has a co-ordinating role for these inspections, whilst the responsibility for carrying them out rests with the Competent Authority under whose responsibility the test facility falls. The ad hoc GLP Inspectors Working Group focuses on harmonisation and coordination of GLP-related activities at Community level.
EMA's Clinical and Non-clinical Compliance Service chairs and provides secretarial support to the ad hoc GLP Inspectors Working Group. Members provide the expertise to carry out the group's tasks and play a key role in the development of collaborative projects.
They support the coordination of the provision of GLP advice and provide a link with other groups such as the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP). These links include support to the non-clinical assessors in verifying GLP compliance and contributing to the drafting/revision of guidance addressing GLP compliance.
Exhaustive information about GLP can be found on the websites of the OECD and the European Commission. Questions and answers concerning the interpretation of the two GLP Directives can be found in Questions and answers concerning the implementation of Directives 2004/9/EC and 2004/10/EC on Good Laboratory Practice.
The questions were discussed by Commission services and representatives from the Member States' GLP-monitoring authorities and the answers were approved by the EU GLP Working Group. The document attempts to provide guidance to monitoring authorities, regulatory authorities and test facilities.
The answers represent the opinion of the EU GLP Working Group. The Standard operating procedure for co-ordination of good-laboratory-practice inspections describes the co-ordination of GLP inspections of the non-clinical safety, toxicological and pharmacological studies proposed in human and veterinary applications for marketing authorisations and various post-authorisation applications submitted to the European Medicines Agency through the centralised procedure.
The European Medicines Agency has a co-ordinating role for these inspections, whilst the responsibility for carrying them out rests with the Competent Authority under whose responsibility the test facility falls. The ad hoc GLP Inspectors Working Group focuses on harmonisation and coordination of GLP-related activities at Community level.
EMA's Clinical and Non-clinical Compliance Service chairs and provides secretarial support to the ad hoc GLP Inspectors Working Group. Members provide the expertise to carry out the group's tasks and play a key role in the development of collaborative projects.
They support the coordination of the provision of GLP advice and provide a link with other groups such as the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP). These links include support to the non-clinical assessors in verifying GLP compliance and contributing to the drafting/revision of guidance addressing GLP compliance.
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