EMA Publish Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials

Posted on May 18, 2012 by adam.parker| Leave a comment

The “Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial”1 (‘detailed guidance CT-1’) sets out the requirements as regards data related to an investigational medicinal product (IMP) to be submitted with the request for a clinical trial authorisation in the IMP Dossier (IMPD).

For further details, please view the document below.

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