Eudralex Volume 10 Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials

GUIDELINE ON THE REQUIREMENTS TO THE CHEMICAL AND PHARMACEUTICA

The guideline is to be seen in connection with directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of the Good Clinical Practices in the conduct of clinical trials on medicinal products for human use, which came into force on May 1, 2004 and the pertaining European Commission document “Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial” in its current version. The latter describes the structure of the chemicalpharmaceutical data to be submitted in the Investigational Medicinal Product Dossier (IMPD), however provides no guidance on the required detail of information.