HMA - Recommendation Paper on Principles of GLP

23rd May 2024

HMA

CTCG jointly issues a new recommendation paper on principles of Good Laboratory Practices (GLP) for clinical trial applications under the EU Clinical Trials Regulation (Regulation (EU) No 536/2014), together with relevant EMA and EC working groups and parties. The aim is to provide transparency on the requirements and to clarify the expected level of information on the GLP status to include in the Clinical Trial Application in support of this.

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