Good laboratory practice in non-clinical trials

29 July 2014

Clinical Trials Facilitation Group (CTFG) has prepared a document describing the requirements as to good laboratory practice (GLP) in non-clinical trials.

Applicants are reminded that all pivotal non-clinical studies conducted to support submissions for marketing authorisation applications and clinical trial applications must be conducted in, or inspected by, a country that has implemented the OECD Mutual Acceptance of Data system.

Read more under 7.3 in the updated guideline for applications for authorisation of clinical trials of medicinal products in humans.

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