Investigator medicinal product dossier

According to the joint announcement of the BfArM (Federal Institute for Drugs and Medical Devices) and the Paul-Ehrlich-Institute, the Investigator Medicinal Product Dossier must be submitted when applying for approval of a clinical study. The IMPD must contain detailed information on the following topics:

Quality of the active substance (nomenclature, structure and physical / chemical properties such as pH, melting point, solubility, etc.)

manufacture of the active substance (contact details of the manufacturer, description of the synthesis method and process controls, control of starting materials, control of critical substances, process validation, development of the manufacturing process, manufacturing formula, control of excipients)

documentation on the pharmacological-toxicological tests (characterisation of the active substance with structure elucidation and other characteristics, method description, control of the active substance, information on reference standards, information on the stability of the investigational product)

Draft of the intended labelling of the investigational product(s) according to § 5 GCP-V,

the manufacturing authorisation of all manufacturers,

where applicable, a copy of the import permit into the EU

Documents on the results of clinical trials conducted to date and other clinical findings that have become known,

summary benefit-risk assessment.

Where appropriate, reference may be made in the IMPD to other documents, copies of which shall be submitted. For an investigational medicinal product of an EU Member State, a simplified Investigator Medicinal Product Dossier with the Summary of Product Characteristics may be submitted, if applicable.

The sponsor must update the Investigator's Brochure in the IMPD at least once a year. In the investigational product dossier, the sponsor should demonstrate, on the basis of submitted scientific evidence, that the use of this substance in generating certain reactions is known and is safe for the intended use in the clinical trial.