The Investigational Medicinal Product Dossier is the basis for approval of clinical trials by the competent authorities in the EU.
The Clinical Trials Directive (2001/20/EC) came into force in April 2001, harmonising the laws, regulations and administrative provisions of the Member States relating to the implementation of Good Clinical Practice (GCP) in the conduct of clinical trials on medicinal products for human use. Member States were obliged to transform the requirements outlined in the Directive into the respective national laws by May 2004. The Directive introduced a harmonised procedure for the authorisation to perform a clinical study in any one of the EU Member States. In addition, it defines the documentation to be submitted to the Ethics Committee as well as the Investigational Medicinal Product Dossier (IMPD) to be submitted to the competent authority for approval. Thus, an IMPD is requested whenever the performance of a clinical study in any one of the EU Member States is intended.
The IMPD includes summaries of information related to the quality, manufacture and control of the Investigational Medicinal Product, data from non-clinical studies and from its clinical use. An overall risk-benefit assessment, critical analyses of the non-clinical and clinical data in relation to the potential risks and benefits of the proposed study have to be part of the IMPD. In certain situations, e.g. where the Investigational Medicinal Product has already been authorised as a medicinal product in one of the EU Member States or where clinical studies with the IMP have already been approved by a Member State, a simplified IMPD will be sufficient.